RecruitingPhase 2

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CLAG-based chemotherapy with or without venetoclax in adults ages 18–80 with acute myeloid leukemia (AML), a blood cancer that came back or did not respond to treatment. It aims to see whether adding venetoclax is safe, clears more remaining cancer cells, and helps people live longer without the cancer getting worse or other major study events.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18–80 years old, sign a consent form, and be willing and able to follow study steps.
  • Your AML must have come back after remission or failed to respond after at least 1 round of strong starting treatment or 2 rounds of less intense treatment.
  • AML that developed from MDS, a bone marrow disease, may qualify after certain past treatments. If those treatments included venetoclax, it must have been more than 3 months ago.
  • AML outside the bone marrow is allowed only if AML is also in the bone marrow.
  • You must be able to care for yourself and be up and about for at least half the day. Your organs must work well enough under study rules.
  • If you have HIV, treatment must be working, with no virus detected in your blood within the past 6 months.
  • If you have hepatitis B or C, a virus that affects the liver, no virus can be detected in your blood. Hepatitis C must have been treated or be under treatment; hepatitis B treatment is required if needed.
  • Men and women who could become pregnant must agree to birth control or not having sex before and during the study and for 4 months after the last study drug dose.

Who can't join

  • Your AML resisted venetoclax, you took it less than 3 months ago, or you previously received high-dose cytarabine treatment.
  • You had a donor stem cell transplant within 3 months or AML treatment too recently. The wait is 14 days or the time for most of the drug to leave your body, whichever is shorter; hydroxyurea does not count.
  • You have a known past TP53 gene change, AML in the brain or spinal cord, or a white blood cell count of 25,000 or higher when treatment starts.
  • You have an uncontrolled illness, mental health condition, or life situation that would prevent you from following study steps, or another cancer needing treatment, with some exceptions.
  • You recently took medicine that weakens the immune system, except low-dose prednisone or a similar drug, or have active or uncontrolled graft-versus-host disease, when donor cells attack your body.
  • You still have more than mild side effects from past cancer treatment, other than hair loss, or are taking another experimental drug.
  • You have heart disease that prevents use of mitoxantrone, a study drug, or had a heart attack less than 6 months ago.
  • You are pregnant. Breastfeeding must stop during treatment because the drugs may harm a nursing baby.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if \> 3 months from venetoclax exposure), and/or 1 cycle of induction chemotherapy. * Extramedullary AML with marrow involvement is allowed as long as concurrent medullary AML is present. * ECOG performance status ≤ 2. * Participants must have adequate organ function as defined within the protocol. * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not mandatory. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and have an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is not mandatory. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 4 months after completion of study drug administration. Exclusion Criteria: * 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. * Known history of prior TP53 mutation (results from any myeloid mutation panel are not required for screening eligibility). * Active CNS involvement by AML. * WBC count ≥25k at the time study treatment begins. * Uncontrolled intercurrent systemic illness that would limit compliance. * Concurrent malignancy in addition to AML that requires active treatment with some exceptions. * Immunosuppressive therapy in the past 14 days except for prednisone at ≤ 10 mg/day or equivalent AND no active or uncontrolled graft-versus-host disease (GvHD). * Participants who have not recovered from adverse events (Aes) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1), with the exception of alopecia. * Participants who are receiving any other investigational agents. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Patients with active heart disease that limits the use of mitoxantrone or recent (\<6 months) history of an acute cardiovascular event (STEMI, NSTEMI). * Pregnant women are excluded from this study because venetoclax, cladribine, and cytarabine are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued.

Study sites (2)

FL

  • Moffitt Cancer Center · Tampa, FL 33612David Sallman, MD · Principal investigatorOnyee Chan, MD · Sub-investigatorRami Komrokji, MD · Sub-investigatorTimothy Kubal, MD · Sub-investigatorMore trials in Tampa

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