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Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)

NCT03207542 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-07-26

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if daratumumab can help to control B- or T-cell acute lymphoblastic leukemia (ALL). The safety of daratumumab will also be studied.

This is an investigational study. Daratumumab is FDA approved and commercially available for treatment of multiple myeloma. It is considered investigational to use daratumumab to treat ALL.

The study doctor can explain how the study drug is designed to work.

Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

  • Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic

Interventions

DRUG

Daratumumab

16 mg/kg by vein weekly for the first 2 cycles (8 weeks) of treatment, followed by every 2 weeks for 4 cycles (or 16 weeks) and then every 4 weeks until progression or up to 1 year of treatment whichever comes earlier.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gautam Borthakur, MBBS · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2020-07-31
Completion
2021-07-31
FDA Drug
Yes

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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 NCT03207542 on ClinicalTrials.gov