Trial Outcomes & Findings for Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms (NCT NCT02756572)
NCT ID: NCT02756572
Last Updated: 2021-11-08
Results Overview
Success will be defined as enrollment of at least 30 patients with transplants occurring in 15 of these 30 (50%) within 60 days of enrollment or start of induction chemotherapy with G-CLAM, whichever is earlier.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 60 days after start of chemotherapy
Results posted on
2021-11-08
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, HCT)
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, HCT)
n=30 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
|---|---|
|
Age, Customized
|
56.5 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
18 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
|
High-Grade Myeloid Diagnosis
Acute myeloid leukemia (AML)
|
29 Participants
n=5 Participants
|
|
High-Grade Myeloid Diagnosis
Myelodysplastic syndrome excess blasts 2 (MDS EB-2)
|
1 Participants
n=5 Participants
|
|
Disease Status
Relapsed
|
16 Participants
n=5 Participants
|
|
Disease Status
Refractory
|
14 Participants
n=5 Participants
|
|
Treatment Related Mortality Score
|
2.33 units on a scale (0-100)
n=5 Participants
|
|
ELN 2017 Risk Stratification
Favorable
|
5 Participants
n=5 Participants
|
|
ELN 2017 Risk Stratification
Intermediate
|
10 Participants
n=5 Participants
|
|
ELN 2017 Risk Stratification
Adverse
|
15 Participants
n=5 Participants
|
|
Prior Lines of Therapy
|
2 Number of prior treatment regimens
n=5 Participants
|
|
Duration of First Complete Remission
|
2 Months
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days after start of chemotherapySuccess will be defined as enrollment of at least 30 patients with transplants occurring in 15 of these 30 (50%) within 60 days of enrollment or start of induction chemotherapy with G-CLAM, whichever is earlier.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=30 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant
Received allogeneic HCT on study within 60 days (feasibility success)
|
9 Participants
|
—
|
|
Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant
Did not receive allogeneic HCT on study within 60 days (feasibility failure)
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 months after early allogeneic HCT on studyPopulation: Nine subjects received allogeneic HCT on study, however one subject died shortly after HCT and was not including in this analysis.
Success will be defined as observing a 40% of higher 6-month relapse-free survival among patients who received early transplant on study.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant
No relapse within 6 months post-HCT (feasibility success)
|
6 Participants
|
—
|
|
Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant
Relapse within 6 months post-HCT (feasibility failure)
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days after early allogeneic HCTPopulation: Nine subjects received allogeneic HCT on study, however one subject died shortly after HCT and was not including in this analysis.
Complete Remission (CR), defined as \<5% blasts in bone marrow with hematologic recovery (ANC\>1000/ul and platelets \>100,000/ml). CRi, defined as complete remission with insufficient hematologic recovery (ANC\<1000/ul or platelets\<100,000/ul). CRp, defined as complete remission but platelets \<100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria. Morphologic leukemia-free state (MLFS), defined as \<5% blasts in bone marrow with no hematologic recovery. Relapse, defined as \>5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
MLFS with MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
MLFS without MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
Relapse
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
CR with MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
CR without MRD
|
7 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
CRi with MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
CRi without MRD
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 84 days after early allogeneic HCTPopulation: Nine subjects received allogeneic HCT on study, however one subject died shortly after HCT and was not included in this analysis.
Complete Remission (CR), defined as \<5% blasts in bone marrow with hematologic recovery (ANC\>1000/ul and platelets \>100,000/ml). CRi, defined as complete remission with insufficient hematologic recovery (ANC\<1000/ul or platelets\<100,000/ul). CRp, defined as complete remission but platelets \<100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria. Morphologic leukemia-free state (MLFS), defined as \<5% blasts in bone marrow with no hematologic recovery. Relapse, defined as \>5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
CR with MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
CR without MRD
|
4 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
CRi with MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
MLFS with MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
MLFS without MRD
|
0 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
Relapse
|
2 Participants
|
—
|
|
Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
CRi without MRD
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantRelapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Relapse-free Survival (RFS) Among Patients Who Received Early Transplant
|
91 Percentage of participants
Interval 85.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to 6 months post-transplantRelapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Relapse-free Survival (RFS) Among Patients Who Received Early Transplant
|
82 Percentage of participants
Interval 62.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantEvent-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Event-free Survival (EFS) Among Patients Who Received Early Transplant
|
91 Percentage of participants
Interval 85.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to 6 months post-transplantEvent-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Event-free Survival (EFS) Among Patients Who Received Early Transplant
|
82 Percentage of participants
Interval 62.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantOverall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Overall Survival (OS) Among Patients Who Received Early Transplant.
|
91 Percentage of participants
Interval 85.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to 6 months post-transplantOverall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Overall Survival (OS) Among Patients Who Received Early Transplant.
|
82 Percentage of participants
Interval 62.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days after induction day 1Overall survival among patients who did not receive early allogeneic HCT on study as estimated with the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=21 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
|
75 Percentage of participants
Interval 60.0 to 97.0
|
—
|
SECONDARY outcome
Timeframe: Up to 6 months after induction day 1Overall survival among patients who did not receive early allogeneic HCT on study as estimated with the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=21 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
|
62 Percentage of participants
Interval 44.0 to 87.0
|
—
|
SECONDARY outcome
Timeframe: At day 100Acute graft versus host disease (graded II, III, or IV) among patients who received early allogeneic HCT on study.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Acute Graft Versus Host Disease Among Patients Who Received Early Transplant
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At day 100Treatment related mortality calculated among patients who received early allogeneic HCT on study vs patients who did not receive early transplant on study.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
n=21 Participants
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Treatment Related Mortality Among Patients Who Received Early Transplant vs Patients Who Did Not Receive Early Transplant
|
9 Percentage of participants
Interval 0.0 to 27.0
|
23.8 Percentage of participants
Interval 5.0 to 43.0
|
SECONDARY outcome
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)Population: Only 18 of the 21 patients who did not receive an allogeneic hematopoietic peripheral blood stem cell within 60 days of bridge chemotherapy on study were analyzed.
Patients who receive early transplant will be compared to those that don't using the Wilcoxon rank sum test for the quantitative variable of treatment-related mortality (TRM). This outcome measure is intended to report a predicted TRM score assessed at the time of feasibility evaluation. The TRM score is used to measure "treatment-related mortality," or likelihood of death within 28 days of initiation of induction chemotherapy for patients with AML. The score is normalized from 0 to 100, so that a score of 0 demonstrates the patient has a very low likelihood of TRM and a score of 100 a very high likelihood of death. A calculation is used to predict TRM using age, performance status, if they have secondary AML, albumin, creatinine, platelet count, white blood cell count, and peripheral blood blast percentage. The higher the TRM score, the higher the risk of TRM. Calculator and table of relationship between TRM score and TRM probability found here: https://trmcalculator.fredhutch.org/.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
n=18 Participants
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - TREATMENT RELATED MORTALITY
|
2.15 units on a scale
Interval 0.61 to 3.67
|
3.045 units on a scale
Interval 0.57 to 8.2
|
SECONDARY outcome
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)Patients who receive early transplant will be compared to those that don't using the Fisher's exact test for the categorical variables of gender.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
n=21 Participants
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - GENDER
Female
|
8 Participants
|
10 Participants
|
|
Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - GENDER
Male
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)Patients who receive early transplant will be compared to those that don't using the Wilcoxon rank sum test for the quantitative variable of age.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=9 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
n=21 Participants
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - AGE
|
55 years
Interval 36.0 to 67.0
|
57 years
Interval 28.0 to 69.0
|
SECONDARY outcome
Timeframe: Up to 12 months post-HCTPopulation: The number analyzed in each of the rows below represent the patients alive at that timepoint who were due to complete a survey.
The amount of returned patient-reported outcome questionnaires will be summarized for each collection timepoint using percent collection from surviving patients for PRO timepoints.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=30 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
Enrollment PROs returned
|
27 Participants
|
—
|
|
Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
Post G-CLAM PROs returned
|
23 Participants
|
—
|
|
Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
Pre-HCT PROs returned
|
8 Participants
|
—
|
|
Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
6 months post-HCT PROs returned
|
4 Participants
|
—
|
|
Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
12 months post-HCT PROs returned
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the first year of induction chemotherapy on studyThe amount of days of hospitalization (the major driver of costs within the first year) will be collected for resource utilization.
Outcome measures
| Measure |
Treatment (Chemotherapy, HCT)
n=30 Participants
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine). HCT conditioning consisted of fludarabine and melphalan, with total body irradiation for patients over age 55 or with significant co-morbidities. HCT was to be received within 60 days of starting G-CLAM chemotherapy.
|
Did Not Receive Allogeneic HCT on Study
Patients who did not receive an allogeneic hematopoietic peripheral blood stem cell transplantation within 60 days of bridge chemotherapy on study.
|
|---|---|---|
|
Demonstrate the Feasibility of Collecting Resource Utilization Data for Trial Participants
|
49 days
Interval 32.0 to 56.0
|
—
|
Adverse Events
Post-Chemotherapy
Serious events: 30 serious events
Other events: 0 other events
Deaths: 5 deaths
Post-Transplant
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Post-Chemotherapy
n=30 participants at risk
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine).
|
Post-Transplant
n=9 participants at risk
Allogeneic peripheral blood stem cell transplant with reduced-intensity conditioning regimen consisted of fludarabine and melphalan, with total body irradiation for subjects over age 55. Prophylaxis for acute graft-vs-host-disease was mycophenylate mofetil (MMF), cyclosporine, and sirolimus.
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Number of events 3 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Nervous system disorders
Intracranial lesions
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Nervous system disorders
Syncope
|
6.7%
2/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Nervous system disorders
Stroke
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Nervous system disorders
Encephalopathy
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Psychiatric disorders
Hallucinations
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 3 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Typhlitis
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Bowel perforation
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Diverticulitis
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Nausea with vomiting
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
33.3%
3/9 • Number of events 4 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
66.7%
6/9 • Number of events 6 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
44.4%
4/9 • Number of events 4 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
2/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Metabolism and nutrition disorders
Blood bilirubin increased
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
5/30 • Number of events 5 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxemic respiratory failure
|
6.7%
2/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse aveolar hemorrhage
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Cardiac disorders
Heart failure
|
6.7%
2/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Cardiac disorders
Cardiogenic shock
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Cardiac disorders
Cardiac arrest
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
3/30 • Number of events 3 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Immune system disorders
Allergic reaction
|
6.7%
2/30 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
3/30 • Number of events 3 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Infections and infestations
Lung infection
|
20.0%
6/30 • Number of events 7 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Infections and infestations
Skin infection
|
10.0%
3/30 • Number of events 3 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
46.7%
14/30 • Number of events 17 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
88.9%
8/9 • Number of events 8 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Infections and infestations
Bacteremia
|
40.0%
12/30 • Number of events 16 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Infections and infestations
Sepsis
|
6.7%
2/30 • Number of events 3 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Hepatobiliary disorders
Hepatic failure
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Hepatobiliary disorders
Liver fibrosis
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Investigations
Ejection fraction decreased
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
22.2%
2/9 • Number of events 2 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
General disorders
Edema in limbs
|
0.00%
0/30 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
11.1%
1/9 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
General disorders
Multi-organ failure
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
|
General disorders
Deconditioning/poor functional status
|
3.3%
1/30 • Number of events 1 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
0.00%
0/9 • Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are "successes" • The date the subject is off-study, for subjects who are "failures" and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.
Other (not including serious) adverse events were not collected and reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Mary-Elizabeth Percival, MD, MS
University of Washington/Seattle Cancer Care Alliance
Phone: 206-606-1320
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place