BCL2i CLAG-M in R/R Acute Myeloid Leukemia

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06660368
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Relapsed or Refractory Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen — DRUG
    Filgrastim/G-CSF 300 mcg/day for 6 days beginning 24 hours prior to multiagent chemotherapy (days 0-5), cladribine 5 mg/m2 given intravenously over 2 hours for 5 consecutive days (days 1-5), cytarabine given IV over 4 hours for 5 consecutive days (days 1-5) beginning 2 hours after the completion of cladribine, and mitoxantrone 16 mg/m2 given intravenously over 30 minutes for 3 days (days 1-3) after completion of cytarabine.
  • Venetoclax — DRUG
    Venetoclax will be administered orally, once daily, with food.

Study Details

This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.

Key Dates

Start date
Nov 26, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CLAG-based therapy with venetoclax
    Study participants will receive CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone) and Venetoclax
  • Active Comparator: CLAG-based therapy without venetoclax
    Study participants will receive CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone)

Primary Outcome Measure

MRD-Negative Remission Rate [ Time Frame: Up to 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
David Sallman, MD (PRINCIPAL_INVESTIGATOR)
Onyee Chan, MD (SUB_INVESTIGATOR)
Rami Komrokji, MD (SUB_INVESTIGATOR)
Timothy Kubal, MD (SUB_INVESTIGATOR)
Jeffrey Lancet, MD (SUB_INVESTIGATOR)
Eric Padron, MD (SUB_INVESTIGATOR)
Alison Walker, MD (SUB_INVESTIGATOR)
Zoey Xie, MD (SUB_INVESTIGATOR)
Seongseok Yun, MD, PhD (SUB_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jacqueline Garcia, MD
[email protected]
617-632-1906
Jacqueline Garcia, MD (PRINCIPAL_INVESTIGATOR)

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Moffitt Cancer Center· Tampa, FLDana-Farber Cancer Institute· Boston, MA

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