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BCL2i CLAG-M in R/R Acute Myeloid Leukemia

ConditionRelapsed or Refractory Acute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.

Adults aged ≥18 years - 80 years.

Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., <5% blasts in BM or blood) with or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission, meeting one or more of the following criteria: ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease.

Disqualifiers

Venetoclax-refractory disease or recent venetoclax exposure < 3 months prior to first dose of study therapy.

Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG/FLAG/MEC/CLIA/HAM, etc.).

Allogeneic stem cell transplant in the past 3 months.

Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: CLAG-based therapy with venetoclaxExperimental treatment 2 interventions
Group B: CLAG-based therapy without venetoclaxActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MRD-Negative Remission Rate

The rate of MRD negative remission will be calculated for each arm.

Time frame
Up to 18 months

Secondary outcomes

1

Event-free survival (EFS)

EFS will be measured from the date of randomization to the first of: failure to achieve composite CR by the end of induction, relapse after achieving composite CR, or death from any cause

Time frame
Up to 18 months
2

Treatment-Related Toxicities

The number of participants who experience an AE or SAE.

Time frame
Up to 18 months
3

Overall survival (OS) based on treatment arm

OS is defined as time from treatment initiation to death or last follow-up if alive at last follow-up.

Time frame
Up to 18 months

Other outcomes

Sponsors and contacts

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

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov
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