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Antimetabolites
Daratumumab for Lymphoblastic Leukemia-Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
B-cell cohort: Stage 1; ALL in second or greater relapse or refractory to 2 prior induction regimens with greater than or equal to (>=) 5 percent (%) blasts in the bone marrow and aged 1 to less than (<) 18 years. Stage 2; ALL in second or greater relapse or refractory to 2 prior induction regimens with (>=) 5% blasts in the bone marrow and aged 1 to 30 years. LL in second or greater relapse or refractory to 2 prior induction regimens and biopsy proven and with evidence of measurable disease by radiologic criteria and aged 1 to 30 years.
T-cell cohort: Stage 1; ALL in first relapse or refractory to 1 prior induction/consolidation regimen with (>=) 5% blasts in the bone marrow and aged 1 to <18 years. Stage 2; ALL in first relapse or refractory to 1 prior induction/consolidation regimen with (>=) 5% blasts in the bone marrow and aged 1 to 30 years. LL in first relapse or refractory to 1 prior induction/consolidation regimen biopsy proven and with evidence of measurable disease by radiologic criteria and aged 1 to 30 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years 4 months
Awards & highlights
Study Summary
This trial will test if adding daratumumab to standard chemotherapy can improve the CR rate in children with relapsed/refractory B-cell or T-cell ALL/LL.
Eligible Conditions
- Lymphoblastic Leukemia-Lymphoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
Secondary outcome measures
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Event-free Survival (EFS)
Maximum Observed Serum Concentration (Cmax) of Daratumumab
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: T-Cell ALL/LLExperimental Treatment9 Interventions
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.
Group II: Cohort 1: B-Cell Acute Lymphoblastic Leukemia (ALL)/LLExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
6-mercaptopurine
2018
Completed Phase 2
~150
Daratumumab
2014
Completed Phase 3
~1860
Vincristine
2003
Completed Phase 4
~2920
Peg-asparaginase
2018
Completed Phase 2
~50
Cytarabine
2016
Completed Phase 3
~3310
Methotrexate
2013
Completed Phase 4
~3800
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,675 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,861 Total Patients Enrolled
Frequently Asked Questions
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