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Daratumumab

Immunoglobulins

Patients receive daratumumab 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.

Gautam Borthakur

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.

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.

Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

An Open-Label, Phase 2 Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome

Response rate as determined by the International Working Group recommendations. Complete remission (CR): The patient must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1.0 x 109/L, platelet count \>/- 100 x 109/L, and normal bone marrow differential (\</= 5% blasts). Complete remission without platelet recovery (CRp): As per CR but platelet count \< 100 x 109/L. Partial remission (PR): CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Marrow CR: Bone marrow: \</= 5% myeloblasts and decrease by \>/= 50% over pre-treatment (MDS only). Morphologic leukemia-free state: Normal marrow differential (\<5% blasts); absolute neutrophil count and platelet counts are not considered. (AML only). Hematologic Improvement (HI): HI should be described by the number of individual, positively affected cell lines

Time from date of start of study medication until date of off study.

Time from date of treatment start until date of death due to any cause or last Follow-up.

Time from date of treatment start until the date of first objective documentation of disease-relapse.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Patients receive daratumumab 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 for up to 1 year in the absence of disease progression or unacceptable toxicity.

Daratumumab: Given IV

Treatment (Daratumumab)

Patients receive daratumumab 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.

Daratumumab: Given IV

Spots Global Cancer Trial Database for Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

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