A Phase 2 interventional study of Daratumumab and Vincristine in Precursor Cell Lymphoblastic Leukemia-Lymphoma, sponsored by Janssen Research & Development, LLC. Completed at 53 sites in 10 countries. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
Screening for eligible participants will be performed within 21 days before administration of the study drug. Participants with B-cell ALL/LL will receive treatment until disease progression, unacceptable toxicity or achievement of CR followed by hematopoietic stem cell transplant (HSCT). Participants with T cell ALL/LL will receive treatment for up to 2 cycles. If disease progression is confirmed, then the participant will discontinue study treatment, complete the End of Treatment Visit, and enter the Posttreatment Period. For those participants who discontinue study drug prior to disease progression, disease evaluations will continue to be performed every 8 weeks until subsequent anticancer therapy is initiated.
Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) as defined by the criteria below:
Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing defined as follows:
Adequate liver function prior to enrollment defined as:
Exclusion Criteria:
Has either of the following:
Any one of the following:
Cohort 1 will include participants with B cell ALL/LL in second or greater relapse or refractory to at least 2 prior induction regimens. Participant will receive daratumumab in combination with vincristine and prednisone.
Drug: Daratumumab · Drug: Vincristine · Drug: Prednisone
Cohort 2 will include participants with T-cell ALL/LL in first relapse or refractory to at least 1 prior induction/consolidation regimen. Participant will receive daratumumab in combination with vincristine, prednisone, doxorubicin and peg-asparaginase in Cycle 1 and daratumumab in combination with cyclophosphamide, cytarabine, 6- mercaptopurine and methotrexate in Cycle 2.
Drug: Daratumumab · Drug: Vincristine · Drug: Prednisone · Drug: Doxorubicin · Biological: Peg-asparaginase · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: 6-mercaptopurine · Drug: Methotrexate
Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.
Participant will receive vincristine 1.5 milligram per meter square (mg/m\^2) in cohort 1 and cohort 2.
Participant will receive prednisone 40 mg/m\^2 in cohort 1 and cohort 2.
Participant will receive doxorubicin 60 mg/m\^2 in cohort 2.
Participant will receive peg-asparaginase 2500 units per meter square (U/m\^2) in cohort 2.
Participant will receive cyclophosphamide 1 gram per meter square (g/m\^2) once in cohort 2.
Participant will receive cytarabine 75 mg/m\^2 in cohort 2.
Participant will receive 6-mercaptopurine 60 mg/m\^2 orally daily in cohort 2.
Participant will receive methotrexate 5 g/m\^2 intravenously (IV) in cohort 2.
Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (\>)100\*10\^9 cells/liter (L) and absolute neutrophil count (ANC) \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arm only.
Time frame: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)
Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arms only.
Time frame: End of Cycle 1 (that is, up to 28 days)
Overall Response Rate (ORR)
For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of \>=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions.
Time frame: Up to 4 years 4 months
Event-free Survival (EFS)
EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is \[ie\], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or \>5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis.
Time frame: Up to 4 years 4 months
Relapse-free Survival (RFS)
RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or \>5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis.
Time frame: Up to 4 years 4 months
Overall Survival (OS)
OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event.
Time frame: Up to 4 years 4 months
Minimal Residual Disease (MRD) Negative Rate
MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (\<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry.
Time frame: Up to 4 years 4 months
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported.
Time frame: Up to 4 years 4 months
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum observed serum concentration of daratumumab.
Time frame: Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2
Minimum Observed Serum Concentration (Cmin) of Daratumumab
Cmin was defined as minimum observed serum concentration of daratumumab.
Time frame: Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2
Number of Participants With Anti-daratumumab Antibodies
Number of participants with anti-daratumumab antibodies was reported.
Time frame: Up to 4 years 4 months
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
Time frame: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
| Milestone | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Started | 7 | 24 | 5 | 10 |
| Completed | 7 | 24 | 4 | 10 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (\>)100\*10\^9 cells/liter (L) and absolute neutrophil count (ANC) \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arm only.
| Percentage of participants | Cohort 1: B-cell ALL (1-17 Years) |
|---|---|
| Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL) | 0 (NA to NA) |
Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arms only.
| Percentage of participants | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|
| Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL | 41.7 (24.6 to 60.3) | 60.0 (18.9 to 92.4) | 30.0 (8.7 to 60.7) |
For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of \>=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions.
| Percentage of participants | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Overall Response Rate (ORR) | 14.3 (0.7 to 52.1) | 83.3 (65.8 to 94.1) | 80.0 (34.3 to 99.0) | 50.0 (22.2 to 77.8) |
EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is \[ie\], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or \>5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis.
| Months | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Event-free Survival (EFS) | 1.1 (0.9 to 2.1) | 8.9 (5.3 to NA) | 10.3 (2.6 to NA) | 2.9 (1.3 to 4.9) |
RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or \>5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis.
| Months | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Relapse-free Survival (RFS) | — | 19.4 (5.3 to NA) | 9.4 (3.6 to NA) | NA (1.8 to NA) |
OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event.
| Months | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Overall Survival (OS) | 3.2 (1.0 to 3.6) | 10.9 (6.7 to NA) | 12.0 (4.5 to NA) | 4.2 (1.7 to 5.6) |
MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (\<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry.
| Percentage of participants | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Minimal Residual Disease (MRD) Negative Rate | 0 (0 to 0) | 45.8 (28.2 to 64.2) | 20.0 (1.0 to 65.7) | 50.0 (22.2 to 77.8) |
Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported.
| Percentage of participants | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | 14.3 (0.7 to 52.1) | 75.0 (56.5 to 88.5) | 60.0 (18.9 to 92.4) | 30.0 (8.7 to 60.7) |
Cmax was defined as maximum observed serum concentration of daratumumab.
| Micrograms per milliliter (mcg/mL) | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Daratumumab | 494 ± 184 | 763 ± 185 | 501 ± 347 | 758 ± 157 |
Cmin was defined as minimum observed serum concentration of daratumumab.
| mcg/mL | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Minimum Observed Serum Concentration (Cmin) of Daratumumab | 172 ± 115 | 369 ± 105 | 172 ± 177 | 365 ± 204 |
Number of participants with anti-daratumumab antibodies was reported.
| Participants | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Number of Participants With Anti-daratumumab Antibodies | 0 | 0 | 0 | 0 |
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
| mcg/mL | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Cycle 1 Day 1 predose | NA ± NA | NA ± NA | NA ± NA | NA ± NA |
| Cycle 1 Day 15 predose | — | 0.907 ± 1.96 | 0.319 ± 0.203 | 0.456 ± 0.280 |
| Cycle 2 Day 1 predose | 0.573 ± 0.545 | — | — | — |
| Cycle 2 Day 2 predose | — | 0.915 ± 0.916 | 0.296 ± 0.191 | 1.23 ± 0.728 |
| Cycle 2 Day 15 predose | — | 0.934 ± 0.549 | 0.163 | 1.06 ± 0.282 |
Collected over From baseline (Day 1) up to 4 years 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: B-cell ALL (1-17 Years) | 7/7 (100%) | 3/7 (42.9%) | 7/7 (100%) |
| Cohort 2: T-Cell ALL (1-17 Years) | 14/24 (58.3%) | 16/24 (66.7%) | 24/24 (100%) |
| Cohort 2: T-Cell ALL (18-30 Years) | 3/5 (60%) | 4/5 (80%) | 5/5 (100%) |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 8/10 (80%) | 7/10 (70%) | 10/10 (100%) |
| Event | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 3/7 | 6/24 | 1/5 | 2/10 |
| PyrexiaGeneral disorders | 0/7 | 7/24 | 1/5 | 1/10 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/7 | 0/24 | 1/5 | 0/10 |
| StomatitisGastrointestinal disorders | 0/7 | 1/24 | 1/5 | 0/10 |
| PainGeneral disorders | 0/7 | 0/24 | 1/5 | 0/10 |
| CellulitisInfections and infestations | 0/7 | 1/24 | 1/5 | 0/10 |
| Septic ShockInfections and infestations | 0/7 | 2/24 | 1/5 | 0/10 |
| Weight DecreasedInvestigations | 0/7 | 0/24 | 1/5 | 0/10 |
| Decreased AppetiteMetabolism and nutrition disorders | 0/7 | 0/24 | 1/5 | 0/10 |
| DeliriumPsychiatric disorders | 0/7 | 0/24 | 1/5 | 0/10 |
| Event | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 4/7 | 16/24 | 2/5 | 10/10 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/7 | 18/24 | 3/5 | 9/10 |
| ConstipationGastrointestinal disorders | 2/7 | 6/24 | 4/5 | 2/10 |
| HyperbilirubinaemiaHepatobiliary disorders | 0/7 | 7/24 | 4/5 | 4/10 |
| Blood Alkaline Phosphatase IncreasedInvestigations | 0/7 | 0/24 | 4/5 | 0/10 |
| HyponatraemiaMetabolism and nutrition disorders | 0/7 | 6/24 | 4/5 | 2/10 |
| StomatitisGastrointestinal disorders | 0/7 | 10/24 | 2/5 | 7/10 |
| PyrexiaGeneral disorders | 4/7 | 13/24 | 3/5 | 7/10 |
| NeutropeniaBlood and lymphatic system disorders | 2/7 | 15/24 | 2/5 | 6/10 |
| Abdominal PainGastrointestinal disorders | 2/7 | 12/24 | 3/5 | 4/10 |
| Age, Continuous(years) | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Total |
|---|---|---|---|---|---|
| Mean | 8.1 ± 5.01 | 9.8 ± 4.17 | 22.2 ± 2.77 | 13.5 ± 5.68 | 11.7 ± 6.03 |
| Sex: Female, Male(Participants) | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Total |
|---|---|---|---|---|---|
| Female | 4 | 10 | 0 | 1 | 15 |
| Male | 3 | 14 | 5 | 9 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 2 | 1 | 8 |
| Not Hispanic or Latino | 4 | 16 | 3 | 7 | 30 |
| Unknown or Not Reported | 2 | 4 | 0 | 2 | 8 |
| Race (NIH/OMB)(Participants) | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 0 | 1 |
| White | 5 | 18 | 2 | 8 | 33 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 5 | 0 | 2 | 9 |
| Region of Enrollment(Participants) | Cohort 1: B-cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (1-17 Years) | Cohort 2: T-Cell ALL (18-30 Years) | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Total |
|---|---|---|---|---|---|
| BELGIUM | 0 | 1 | 0 | 0 | 1 |
| FRANCE | 0 | 3 | 0 | 2 | 5 |
| GERMANY | 2 | 0 | 0 | 0 | 2 |
| ISRAEL | 0 | 2 | 0 | 0 | 2 |
| ITALY | 2 | 4 | 0 | 0 | 6 |
| NETHERLANDS | 0 | 2 | 0 | 0 | 2 |
| SPAIN | 2 | 5 | 1 | 4 | 12 |
| UNITED KINGDOM | 0 | 3 | 1 | 1 | 5 |
| UNITED STATES | 1 | 4 | 3 | 3 | 11 |
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