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Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies

ConditionsMyeloid MalignancyHematologic MalignancyAcute Myeloid LeukemiaMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of this study is to determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogenic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male or female, age 18-75 years

Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. Unrelated donor must the following: have Optimum: HLA-A, -B, -C, -DRB1, -DRB3/4/5, -DQA1, -DQB1, -DPA1 and -DPB1; Minimum: HLA-A, -B, -C, -and DRB1 matching at high resolution using DNA-based typing and be willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to National Marrow Donor Program (NMDP) criteria.

A candidate for reduced intensity preparative regimen, based on age≥60, or HCT-CI of ≥4, or considered by the treating physician to have high risk for toxicity with myeloablative preparative regimen.

Cardiac function: Ejection fraction >40%

Disqualifiers

Autologous hematopoietic stem cell transplant < 3 months prior to enrollment.

Previous allogeneic stem cell transplant.

Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.

Known hypersensitivity to Decitabine, Venetoclax and/or ATG.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • G-CSF

    Drug

    Granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.

  • Decitabine

    Drug

    Decitabine is a hypomethylating agent.

  • Venetoclax

    Drug

    Venetoclax is a selective inhibitor of BCL-2 protein.

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Cohort 1: G-CSF + Decitabine (100mg/m2 bid for 2d)Experimental treatment 2 interventions
Group B: Cohort 1 DL-1: G-CSF + Decitabine (50mg/m2 bid for 2d)Experimental treatment 2 interventions
Group C: Cohort 2: G-CSF + Decitabine + Ven (200mg/d for 7d)Experimental treatment 3 interventions
Group D: Cohort 2 DL2: G-CSF + Decitabine + Ven (400mg/d for 7d)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Measuring changes in dose limiting toxicities

Determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.

Time frame
Up to 28 days

Secondary outcomes

1

The average regimen-related toxicity

Rate of grade \>- 4, non-hematologic toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Time frame
At 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov
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