Clinical Trials Directory

Trials / Terminated

TerminatedNCT03067571

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
7 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDaratumumabGiven IV

Timeline

Start date
2017-10-27
Primary completion
2022-11-21
Completion
2022-11-21
First posted
2017-03-01
Last updated
2023-09-21
Results posted
2023-09-21

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03067571. Inclusion in this directory is not an endorsement.