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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07044544
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 17, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: G-CSF + Decitabine (100mg/m2 bid for 2d)
    Cohort 1 DL1: G-CSF + Decitabine (100mg/m2 bid for 2d) G-CSF will be administered subcutaneously on days -14 to -10 at a dose of 5mcg/kg. Hold for wbc \>20k. Decitabine will be investigated at two dose levels. 100mg/m2 bid for 2 days at dose level 1 and 50mg/m2 bid for 2 days at dose level -1. It will be administered as IV in days -11 and -10.
  • Experimental: Cohort 1 DL-1: G-CSF + Decitabine (50mg/m2 bid for 2d)
    Cohort 1 DL-1: G-CSF + Decitabine (50mg/m2 bid for 2d) G-CSF will be administered subcutaneously on days -14 to -10 at a dose of 5mcg/kg. Hold for wbc \>20k. Decitabine will be investigated at two dose levels. 100mg/m2 bid for 2 days at dose level 1 and 50mg/m2 bid for 2 days at dose level -1. It will be administered as IV in days -11 and -10.
  • Experimental: Cohort 2: G-CSF + Decitabine + Ven (200mg/d for 7d)
    Cohort 2 DL1: G-CSF + Decitabine + Ven (200mg/d for 7d) G-CSF will be administered subcutaneously on days -14 to -10 at a dose of 5mcg/kg. Hold for wbc \>20k. Decitabine will be investigated at two dose levels. 100mg/m2 bid for 2 days at dose level 1 and 50mg/m2 bid for 2 days at dose level -1. It will be administered as IV in days -11 and -10. Venetoclax will be investigated at two dose levels. 200mg daily for 7 days as dose level 1 of cohort 2 of the study and 400mg daily for 7 days as dose level 2. It will be administered orally on from days -12 to -6. Venetoclax 400 and 200 mg/day dose will be adjusted if the patient was on fluconazole (down to 200 and 100 mg/day), posaconazole or isavuconazole (100 and 50 mg/day), and voriconazole (50 and 25 mg/day) If cohort 2 DL1 clears the DLT period based on the criteria discussed previously, then we will start accruing patients to DL2 of cohort 2.
  • Experimental: Cohort 2 DL2: G-CSF + Decitabine + Ven (400mg/d for 7d)
    Cohort 2 DL2: G-CSF + Decitabine + Ven (400mg/d for 7d) G-CSF will be administered subcutaneously on days -14 to -10 at a dose of 5mcg/kg. Hold for wbc \>20k. Decitabine will be investigated at two dose levels. 100mg/m2 bid for 2 days at dose level 1 and 50mg/m2 bid for 2 days at dose level -1. It will be administered as IV in days -11 and -10. Venetoclax will be investigated at two dose levels. 200mg daily for 7 days as dose level 1 of cohort 2 of the study and 400mg daily for 7 days as dose level 2. It will be administered orally on from days -12 to -6. Venetoclax 400 and 200 mg/day dose will be adjusted if the patient was on fluconazole (down to 200 and 100 mg/day), posaconazole or isavuconazole (100 and 50 mg/day), and voriconazole (50 and 25 mg/day)

Primary Outcome Measure

Measuring changes in dose limiting toxicities [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Margaret Thomas, MPH
[email protected]
Zaid Al-Kadhimi, MD (SUB_INVESTIGATOR)
Ravi Bhatia, MD (SUB_INVESTIGATOR)
Antonio Di Stasi, MD (SUB_INVESTIGATOR)
Manuel Espinoza-Gutarra, MD (SUB_INVESTIGATOR)
Donna Salzman, MD (SUB_INVESTIGATOR)
Lauren Shea, MD (SUB_INVESTIGATOR)

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