What is venetoclax studying for relapsed or refractory acute myeloid leukemia?

Venetoclax is being studied in combination with CLAG-M chemotherapy to see if it improves disease remission and survival in patients with relapsed or refractory AML. The trial aims to compare the safety and effectiveness of adding venetoclax to standard CLAG-M treatment. This research is led by the H. Lee Moffitt Cancer Center and Research Institute.

Who may be eligible for this relapsed or refractory AML clinical trial?

Adults aged 18 to 80 years with relapsed or refractory AML may be eligible. Participants must have adequate organ function, an ECOG performance status of 2 or less, and must agree to contraception if of childbearing potential. Certain prior treatments and health conditions may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this relapsed or refractory AML clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase 2

Age: 18Years - 80Years

All Genders

ID06660368

Phase II Study Comparing CLAG-M Therapy With or Without Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia in Adults

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a combination therapy for adults with relapsed or refractory acute myeloid leukemia AML in this multicenter, open-label phase II study. The study aims to see if adding the drug venetoclax to the CLAG-M chemotherapy regimen cladribine, cytarabine, G-CSF, mitoxantrone improves the clearance of measurable residual disease and event-free survival compared to CLAG-M alone. This trial is led by the H. Lee Moffitt Cancer Center and Research Institute.

CONDITIONS

Brief Title

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	CLAG-based therapy with venetoclax	CLAG-based therapy without venetoclax
What it is	Combination chemotherapy using cladribine, cytarabine, mitoxantrone, G-CSF (CLAG-M) with the addition of venetoclax, an oral BCL2 inhibitor. Venetoclax is incorporated to potentially enhance AML cell death.	Standard CLAG-M chemotherapy regimen: cladribine, cytarabine, mitoxantrone, and G-CSF, without venetoclax.
Role in this trial	Serves as the investigational arm to assess whether adding venetoclax to standard CLAG-M improves remission rates or other clinical outcomes.	Functions as the active comparator arm; receives CLAG-M without venetoclax to establish the reference for measuring added benefit of venetoclax in this setting.
Primary use	Studied for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML), aiming to improve remission rates and survival compared to CLAG-M alone.	Used as an established intensive salvage regimen for adults with relapsed or refractory AML.
How it is given	Participants receive six days of G-CSF (filgrastim), five days of intravenous cladribine and cytarabine plus three days of intravenous mitoxantrone as chemotherapy, with oral venetoclax once daily, per protocol.	Participants receive six days of G-CSF (filgrastim), five days of intravenous cladribine and cytarabine, and three days of intravenous mitoxantrone, without venetoclax.
Evidence status	Outcomes for CLAG-M plus venetoclax in relapsed or refractory AML are under investigation. Early reports suggest possible improved remission rates, but confirmatory evidence from randomized trials is awaited.	CLAG-M has demonstrated established response rates and is a commonly used salvage regimen in relapsed or refractory AML, with published outcomes on remission and survival.
Important limitations or uncertainties	The safety and survival benefit of adding venetoclax to CLAG-M remains uncertain outside clinical trials. Potential for increased side effects, such as myelosuppression and infections, requires further assessment in randomized studies.	CLAG-M chemotherapy carries significant risks of low blood counts, infection, and treatment-related complications, which may be challenging for older or frail patients.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent form.
Willingness and ability to comply with all study procedures and availability for the study duration.
Adults aged 18 to 80 years.
Documented refractory or relapsed AML as defined by study criteria.
Secondary AML from MDS treated with HMA, HMA + venetoclax (if more than 3 months since venetoclax), or 1 cycle of induction chemotherapy.
Extramedullary AML allowed if marrow involvement is present.
ECOG performance status of 2 or less.
Adequate organ function per protocol.
HIV-infected participants on effective therapy with undetectable viral load within 6 months.
HBV viral load undetectable on suppressive therapy if indicated.
Treated HCV infection with undetectable viral load or currently on treatment with undetectable viral load.
Agreement to use contraception for women of childbearing potential and men during and 4 months after study drug administration.

You will not qualify if you...

Venetoclax-refractory disease or venetoclax exposure less than 3 months before study therapy.
Prior treatment with high-dose cytarabine regimens like CLAG, FLAG, MEC, CLIA, or HAM.
Allogeneic stem cell transplant within the past 3 months.
Less than 14 days since last AML therapy or five half-lives, excluding hydroxyurea.
Known prior TP53 mutation.
Active CNS involvement by AML.
White blood cell count over 25,000 at treatment start.
Uncontrolled systemic illness limiting compliance.
Concurrent malignancy requiring active treatment with some exceptions.
Immunosuppressive therapy within 14 days except low-dose prednisone and no active graft-versus-host disease.
Unresolved adverse events from prior therapy greater than Grade 1 except alopecia.
Receiving other investigational agents.
Psychiatric or social issues limiting compliance.
Active heart disease limiting mitoxantrone use or recent acute cardiovascular events within 6 months.
Pregnant or breastfeeding women due to potential risks from study drugs.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 days per treatment cycle

Participants receive multiagent chemotherapy with CLAG-M regimen, with or without oral Venetoclax, to treat relapsed or refractory acute myeloid leukemia.

Daily visits during treatment cycle

Follow-up

Duration - Up to 18 months

Participants are monitored for treatment response, side effects, and overall health for up to 18 months after treatment.

Regular visits as scheduled by the study team

Research Team

Quan Lovette

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

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Frequently Asked Questions

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Phase II Study Comparing CLAG-M Therapy With or Without Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia in Adults

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Study of Cladribine-Bridged Lisaftoclax and Busulfan Conditi...

Phase I Study of Oral AG-120 for Advanced Blood Cancers with...

Frequently Asked Questions

What is venetoclax studying for relapsed or refractory acute myeloid leukemia?

Who may be eligible for this relapsed or refractory AML clinical trial?

Is there any cost to participate in this relapsed or refractory AML clinical trial?

Will I receive venetoclax or a placebo?

How is disease remission measured in this AML trial?

What happens after this relapsed or refractory AML clinical trial ends?

Can I leave this relapsed or refractory AML clinical trial if I change my mind?

Not the Right Trial for You?

On this page

Sponsors

Sponsors

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Study of Cladribine-Bridged Lisaftoclax and Busulfan Conditi...

Phase I Study of Oral AG-120 for Advanced Blood Cancers with...

Frequently Asked Questions

What is venetoclax studying for relapsed or refractory acute myeloid leukemia?

Who may be eligible for this relapsed or refractory AML clinical trial?

Is there any cost to participate in this relapsed or refractory AML clinical trial?

Will I receive venetoclax or a placebo?

How is disease remission measured in this AML trial?

What happens after this relapsed or refractory AML clinical trial ends?

Can I leave this relapsed or refractory AML clinical trial if I change my mind?

Sponsors