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

Conditions

• Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daratumumab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 31, 2018

Status verified

Jul 2018

Primary completion

Jul 31, 2020

Completion

Jul 31, 2021

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
  Participants receive Daratumumab by vein over about 4 hours on Days 1, 8, 15, and 22 of Cycles 1 and 2, Days 1 and 15 of Cycles 3-6, and then on Day 1 of Cycles 7 and beyond. Each cycle is 28 days.
• Experimental: T-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
  Participants receive Daratumumab by vein over about 4 hours on Days 1, 8, 15, and 22 of Cycles 1 and 2, Days 1 and 15 of Cycles 3-6, and then on Day 1 of Cycles 7 and beyond. Each cycle is 28 days.

Primary Outcome Measure

Overall Response Rate (ORR) in Participants with Relapsed/Refractory B-Cell or T-Cell Precursor Acute Lymphoblastic Leukemia (ALL) [ Time Frame: 12 weeks ]