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Antimetabolites

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic 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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug with standard chemotherapy in children whose blood cancer has returned or didn't respond to treatment. The drug helps the immune system recognize and attack cancer cells.

Eligible Conditions

Acute Lymphoblastic Leukemia
Lymphoblastic Leukemia-Lymphoma

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Concentration of Daratumumab in Cerebrospinal Fluid (CSF)

Event-free Survival (EFS)

Maximum Observed Serum Concentration (Cmax) of Daratumumab

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Methotrexate

2019

Completed Phase 4

~4400

Daratumumab

2014

Completed Phase 3

~2380