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Clinical Trial Summary

This phase II trial studies how well daratumumab works in treating patients with acute myeloid leukemia that has come back or does not respond to treatment or high-risk myelodysplastic syndrome. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Clinical Trial Description

The goal of this clinical research study is to learn if daratumumab in combination with venetoclax can help to control acute myelogenous leukemia (AML), high-risk myelodysplastic syndrome (MDS) that is refractory (does not respond to treatment) or relapsed (comes back after being treated), or relapsed/refractory T acute lymphoblastic leukemia/lymphoma (T-ALL, T-LBL) . OUTLINE: Patients receive daratumumab intravenously (IV) over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days. After completion of study treatment, patients are followed up monthly for 1 year, every 6 months for 1 year, and then annually thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03067571
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date October 27, 2017
Completion date November 21, 2022

See also
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