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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

NCT03384654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-05-25

Study results available
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Summary

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.

Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DRUG

Daratumumab

Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.

DRUG

Vincristine

Participant will receive vincristine 1.5 milligram per meter square (mg/m\^2) in cohort 1 and cohort 2.

DRUG

Prednisone

Participant will receive prednisone 40 mg/m\^2 in cohort 1 and cohort 2.

DRUG

Doxorubicin

Participant will receive doxorubicin 60 mg/m\^2 in cohort 2.

BIOLOGICAL

Peg-asparaginase

Participant will receive peg-asparaginase 2500 units per meter square (U/m\^2) in cohort 2.

DRUG

Cyclophosphamide

Participant will receive cyclophosphamide 1 gram per meter square (g/m\^2) once in cohort 2.

DRUG

Cytarabine

Participant will receive cytarabine 75 mg/m\^2 in cohort 2.

DRUG

6-mercaptopurine

Participant will receive 6-mercaptopurine 60 mg/m\^2 orally daily in cohort 2.

DRUG

Methotrexate

Participant will receive methotrexate 5 g/m\^2 intravenously (IV) in cohort 2.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2022-09-22
Completion
2022-09-27
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384654 on ClinicalTrials.gov