Trial Outcomes & Findings for Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML) (NCT NCT02441803)
NCT ID: NCT02441803
Last Updated: 2024-02-22
Results Overview
Number of participants classified as achieving overall response of complete remission(CR: \< 5% blast in a bone marrow/and platelet \>100/and ANC \>1) or CR without platelet recovery (CRp: \< 5% blast in a bone marrow/and platelet \<100/and ANC \>1) or CR with insufficient hematological recovery (CRi: \< 5% blast in a bone marrow/and platelet \>100/and ANC \<1) post transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
4 months after initial treatment/3 months after transplant
Results posted on
2024-02-22
Participant Flow
All participants were recruited in MD Anderson Cancer Center
Participant milestones
| Measure |
Matched Sibling Donor Group
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
8
|
2
|
|
Overall Study
COMPLETED
|
1
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Matched Sibling Donor Group
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
2
|
Baseline Characteristics
Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Matched Sibling Donor Group
n=1 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
n=8 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
n=2 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
8 participants
n=4 Participants
|
2 participants
n=27 Participants
|
11 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 4 months after initial treatment/3 months after transplantNumber of participants classified as achieving overall response of complete remission(CR: \< 5% blast in a bone marrow/and platelet \>100/and ANC \>1) or CR without platelet recovery (CRp: \< 5% blast in a bone marrow/and platelet \<100/and ANC \>1) or CR with insufficient hematological recovery (CRi: \< 5% blast in a bone marrow/and platelet \>100/and ANC \<1) post transplant.
Outcome measures
| Measure |
Matched Sibling Donor Group
n=1 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
n=8 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
n=2 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Overall Response (OR) Post Transplant
|
1 Participants
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 months post initial treatment/3 months post transplantNumber of participants died from treatment-related death within 4 months post initial treatment/3 months post transplant.
Outcome measures
| Measure |
Matched Sibling Donor Group
n=1 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
n=8 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
n=2 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Treatment-Related Mortality (TRM)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants alive and disease free in 1 year post transplant.
Outcome measures
| Measure |
Matched Sibling Donor Group
n=1 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
n=6 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
n=2 Participants
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Overall Survival (OS)
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Matched Sibling Donor Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Haploidentical Donor Group
Serious events: 5 serious events
Other events: 6 other events
Deaths: 7 deaths
Matched Unrelated Donor Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Matched Sibling Donor Group
n=1 participants at risk
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
n=8 participants at risk
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
n=2 participants at risk
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin GvHD
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Nervous system disorders
Tacrolimus induced PRES
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Secondary Graft Failure due to GvHD
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Fungal Infections
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Viral Infections
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
Other adverse events
| Measure |
Matched Sibling Donor Group
n=1 participants at risk
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched sibling donor stem cell transplant
|
Haploidentical Donor Group
n=8 participants at risk
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received haplo-identical related donor stem cell transplant
|
Matched Unrelated Donor Group
n=2 participants at risk
AML patients with primary induction failure refractory to HD Cytarabine based chemotherapy received matched unrelated donor stem cell transplant
|
|---|---|---|---|
|
Infections and infestations
BK virus associated hemorrhagic cystitis
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
General disorders
Fluid overload
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
50.0%
4/8 • Number of events 4 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
62.5%
5/8 • Number of events 5 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
75.0%
6/8 • Number of events 6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Elevated transminitis
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
75.0%
6/8 • Number of events 6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
100.0%
1/1 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Bacterial Infections
|
0.00%
0/1 • Up to 2 years
|
75.0%
6/8 • Number of events 6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Viral Infections
|
0.00%
0/1 • Up to 2 years
|
75.0%
6/8 • Number of events 6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
GI GvHD
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Liver GvHD
|
0.00%
0/1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Upper GI GvHD
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Renal and urinary disorders
Cytoxan induced cystitis
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Neutropenic fevers
|
0.00%
0/1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Up to 2 years
|
37.5%
3/8 • Number of events 3 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 2 years
|
37.5%
3/8 • Number of events 3 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Elevated bilirubin
|
0.00%
0/1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
Additional Information
Dr. Richard Champlin, MD/Stem Cell Transplantation
University of Texas MD Anderson Cancer Center
Phone: 713-792-3618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place