Trial Outcomes & Findings for Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia. (NCT NCT01041508)
NCT ID: NCT01041508
Last Updated: 2024-02-01
Results Overview
The primary objective of the study is to determine the maximum feasible dose (MFD) of Clofarabine that can be given in combination with 2Gy total body irradiation as a non-myeloablative preparative regimen for allogeneic stem cell transplantation in pediatric patients with relapsed leukemia. The MFD is defined as the highest clofarabine dose associated with both an acceptably low toxicity and low non-engraftment (NE) rate. NE is defined as \< 5% donor T cells at any time point during serial monitoring. Monitoring during the evaluation period is required Day +30, +60 and +100.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Day +100
Results posted on
2024-02-01
Participant Flow
At each dose level, after the first 3 patients or after 6 patients, the dose level will be either escalated to the next dose level, expanded, or de-escalated, or the study will be halted, depending on the number of observed Transplant Related Mortality (TRM) or Severe Renal Insufficiency (SRI) and Non-engraftment (NE) and evaluation status of surrounding dose levels.
Participant milestones
| Measure |
Cohort A - Related Donor- Dose Level 1
Dose Level 1 Clofarabine 40 mg/m\^2. Cohort A will include patients who have matched related donors.
|
Cohort B - Related Donor- Dose Level 2
Dose Level 2 Clofarabine 52 mg/m\^2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
Dose Level 1 Clofarabine 40 mg/m\^2. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donors- Dose Level 2
Dose Level 2 Clofarabine 52 mg/m\^2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
Baseline characteristics by cohort
| Measure |
Cohort A- Related Donor- Dose Level 1
n=3 Participants
Dose Level 1 Clofarabine 40 mg/m\^2. Cohort A will include patients who have matched related donors.
|
Cohort B- Related Donor - Dose Level 2
n=6 Participants
Dose Level 2 Clofarabine 52 mg/m\^2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor - Dose Level 1
n=3 Participants
Dose Level 1 Clofarabine 40 mg/m\^2. Cohort C will include patients who have matched unrelated donors.
|
Cohort D- Unrelated Donor - Dose Level 2
n=6 Participants
Dose Level 2 Clofarabine 52 mg/m\^2. Cohort D will include patients who have matched unrelated donors.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15 years
n=5 Participants
|
5.5 years
n=7 Participants
|
3.5 years
n=5 Participants
|
9 years
n=4 Participants
|
14.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Diagnosis
Acute Lymphoblastic Leukemia (ALL)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Diagnosis
Acute Myeloid Leukemia (AML)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Prior myeloablative allogeneic HSCT
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Prior liver transplantation
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Trisomy 21
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Donor type
Related Donor
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Donor type
Unrelated Donor
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Stem cell source
Peripheral Blood
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Stem cell source
Bone Marrow
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
CD34+ cell dose
|
6.8 million cells per kg
n=5 Participants
|
6.8 million cells per kg
n=7 Participants
|
6.8 million cells per kg
n=5 Participants
|
6.8 million cells per kg
n=4 Participants
|
6.8 million cells per kg
n=21 Participants
|
|
Performance Status
90-100
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Performance Status
80-90
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Performance Status
50-80
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day +100Population: This analysis was performed for the entire study population. Cohorts were not separately analyzed for the maximum feasible dose of clofarabine.
The primary objective of the study is to determine the maximum feasible dose (MFD) of Clofarabine that can be given in combination with 2Gy total body irradiation as a non-myeloablative preparative regimen for allogeneic stem cell transplantation in pediatric patients with relapsed leukemia. The MFD is defined as the highest clofarabine dose associated with both an acceptably low toxicity and low non-engraftment (NE) rate. NE is defined as \< 5% donor T cells at any time point during serial monitoring. Monitoring during the evaluation period is required Day +30, +60 and +100.
Outcome measures
| Measure |
Entire Study Population
n=18 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
Maximum Feasible Dose of Clofarabine
|
52 mg/m^2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days +30, 60, 100, 180Donor engraftment will be assessed by serial monitoring of T-cell (CD3) and myeloid (CD33) chimerism at day +30, 60, 100, 180 and 1 year at the local institution using PCR based VNTR/STR amplification techniques. Neutrophil engraftment is defined as first day of an ANC ≥500/μL on 3 consecutive measurements.
Outcome measures
| Measure |
Entire Study Population
n=3 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
n=3 Participants
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)
|
20 Days
Interval 17.0 to 22.0
|
19.5 Days
Interval 14.0 to 25.0
|
19 Days
Interval 19.0 to 20.0
|
15.5 Days
Interval 9.0 to 19.0
|
SECONDARY outcome
Timeframe: Day 100TRM is defined as any mortality within the first 100 days post stem cell infusion associated with regimen related toxicity, infection, or GVHD.
Outcome measures
| Measure |
Entire Study Population
n=3 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
n=3 Participants
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
Transplant Related Mortality (TRM) at Day +100
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days +30, 60, 100, 180Platelet recovery is defined as the first day of 3 consecutive measurements of platelets ≥20,000/μL after at least 7 days without transfusion support.
Outcome measures
| Measure |
Entire Study Population
n=3 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
n=3 Participants
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
Days to Platelet Recovery
|
10 Days
Interval 7.0 to 17.0
|
13.5 Days
Interval 3.0 to 29.0
|
11 Days
Interval 9.0 to 11.0
|
10.5 Days
Interval 6.0 to 16.0
|
POST_HOC outcome
Timeframe: Within 100 Days Post-SCT (Stem Cell Transplant)Acute GVHD was graded according to consensus grading criteria (Przepiorka D, Weisdorf D, Martin P, et al. 1994 consensus conference on acute GVHD grading. Bone Marrow Transplant. 1995;15:825-828.)
Outcome measures
| Measure |
Entire Study Population
n=3 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
n=3 Participants
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
Number of Participants With Acute GVHD ≥ Grade 2
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
POST_HOC outcome
Timeframe: Day 30Donor engraftment was assessed by testing of chimerism in the T cell (CD3) subpopulation at day +30 done by local institution using PCR-based analyses of polymorphic microsatellite regions.
Outcome measures
| Measure |
Entire Study Population
n=3 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
n=5 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
n=3 Participants
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
CD3 Donor Chimerism at Day 30 (Full Donor)
|
2 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
POST_HOC outcome
Timeframe: Day 30Donor engraftment was assessed by testing of chimerism in the T cell (CD3) subpopulation at day +30 done by local institution using PCR-based analyses of polymorphic microsatellite regions.
Outcome measures
| Measure |
Entire Study Population
n=3 Participants
Maximum Feasible Dose (MFD) was analyzed across all cohorts of the study. This includes all 18 patients who were enrolled on to this trial
|
Cohort B- Related Donor- Dose Level 2
n=5 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort B will include patients who have matched related donors.
|
Cohort C- Unrelated Donor- Dose Level 1
n=3 Participants
Dose Level 1 is the starting dose level of Clofarabine will be 40 mg/m2/dose given day -6 through -2. A modified 3+3 patient cohort dose escalation and de-escalation design. Cohort C will include patients who have unrelated donors.
|
Cohort D- Unrelated Donor- Dose Level 2
n=6 Participants
Dose Level 2 of Clofarabine will be administered 52 mg/m2/dose Day -6 through -2. Cohort D will include patients who have unrelated donors.
|
|---|---|---|---|---|
|
CD3 Donor Chimerism at Day 30 (Mixed Chimerism)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
40 mg/m2 Dose
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
52 mg/m2 Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
40 mg/m2 Dose
n=6 participants at risk
Patients who received the starting dose level of 40 mg/m2
|
52 mg/m2 Dose
n=12 participants at risk
Patients who received the increased dose level of 52 mg/m2
|
|---|---|---|
|
General disorders
Fever
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
Other adverse events
| Measure |
40 mg/m2 Dose
n=6 participants at risk
Patients who received the starting dose level of 40 mg/m2
|
52 mg/m2 Dose
n=12 participants at risk
Patients who received the increased dose level of 52 mg/m2
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Endocrine disorders
Adrenal insufficiency NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
6/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
33.3%
4/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
41.7%
5/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Aspartate aminotransferase increased
|
83.3%
5/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
25.0%
3/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Dermatology-Other
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Diarrhea NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Hemoglobin
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
25.0%
3/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Hemoglobinuria
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypoglycemia NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
16.7%
2/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Vascular disorders
Hypotension NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection w/ Gr 3/4 ANC, Blood
|
16.7%
1/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection w/ norm ANC, Catheter
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection w/ norm ANC, Colon
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection-Other
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
50.0%
3/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
41.7%
5/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
2/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
41.7%
5/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Metabolic/Lab-Other
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
16.7%
2/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Neutrophil count
|
50.0%
3/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
41.7%
5/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Pain - Other
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
33.3%
2/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
58.3%
7/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
16.7%
2/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Vomiting NOS
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Weight increased
|
0.00%
0/6 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
8.3%
1/12 • 3 years, 1 month
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
Additional Information
Peggy Romano, BA, CCRP
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles
Phone: 323-361-5505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60