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

Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic Clinical Trial

Official title: An Open-label Phase 2 Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Study Drug Administration:

Each cycle is 28 days.

If you are found to be eligible to take part in this study, you will 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. Your first dose of daratumumab will be given over about 7 hours.

In this study, the following will be done to lower the chance of a daratumumab infusion related reaction:

• You will get medications, including steroids, acetaminophen, and/or antihistamine before the infusion. If you are considered high risk, you may also get medications, including inhaled steroids, after the infusion.

• The infusion may be slowed down or stopped if you have a reaction.

• You may stay overnight in the hospital after the infusion so the study staff can check your health.

You may ask the study staff for information about how these drugs are given and their risks. You may also be asked to stay in the hospital overnight to watch you for side effects, if needed.

Length of Study:

You may receive daratumumab for up to 1 year. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Study Visits:

Within 24 hours before your first dose of study drug, if you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

Every 2 weeks during Cycles 1-6, blood (about 1 teaspoon) will be drawn for CMV testing.

On Day 1 of Cycles 1 and 2:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• During Cycle 2, you will have a bone marrow aspirate/biopsy to check the status of the disease.

On Days 8, 15, 22 of Cycles 1 and 2, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 3-6:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• During Cycle 3, you will have an EKG.

• If you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

On Day 1 of Cycles 3 and beyond, you will have a bone marrow biopsy/aspirate to check the status of the disease. If the disease appears to be responding to the study drug, the study doctor will decide how often you will have this procedure.

On Day 15 of Cycles 3-6, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 7 and beyond:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests and CMV testing.

• During Cycle 7 only, you will have an EKG.

• If you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

End of Treatment:

About 28-35 days after the last dose of daratumumab:

• You will have a physical exam.

• You will have an EKG.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• If the doctor thinks it is needed, you may have a bone marrow biopsy/aspiration to check the status of the disease.

Follow-Up Visits:

The study staff will call you to ask how you are doing 1 time each month for the first year after your End-of-Treatment visit, then every 6 months during the second year after the visit, and then 1 time every year after that. Each call should last about 5 minutes.

At 30 and 60 days after your last dose of study drug and then every 2-3 months after that for 1 year:

• You will have a physical exam.

• If the disease appeared to be responding to the study drug, blood (about 2 teaspoons) will be drawn for routine tests. Every 4-12 weeks, this sample may be used for CMV testing. If the disease appears to get worse, you will stop having these blood draws.

• If the disease appeared to be responding to the study drug, you will have a bone marrow aspirate and/or biopsy.

• If the disease appeared to be responding to the study drug, you will have an EKG at your first follow-up visit.

After 1 year, you may continue to have follow-up visits as part of your routine care. This will be discussed with you by the study doctor in more detail. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT03207542
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2018
• Completion date: July 2021