Venetoclax + CLAG-M for AML

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by David Sallman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Investigational agents

Disqualifiers: Venetoclax refractory, CNS involvement, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had AML-directed therapy within 14 days before starting the trial, except for hydroxyurea, and you should not be on immunosuppressive therapy except for low-dose prednisone.

What data supports the effectiveness of the drug Venetoclax for AML?

Research shows that Venetoclax, when used with other treatments, can help some patients with relapsed or refractory acute myeloid leukemia (AML) achieve remission, although the overall survival rates are generally low. In one study, 52% of patients who survived more than two months achieved complete remission or remission with incomplete blood count recovery. ^{1 2 3 4 5}

How does the drug Venetoclax + CLAG-M differ from other treatments for AML?

Venetoclax, when combined with CLAG-M, offers a novel approach for treating acute myeloid leukemia (AML) by targeting the B-cell lymphoma 2 protein, which helps cancer cells survive. This combination is unique because it pairs venetoclax with a chemotherapy regimen (CLAG-M), potentially enhancing its effectiveness in patients who may not respond well to standard treatments. ^{1 4 6 7 8}

Research Team

David Sallman, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for patients with acute myeloid leukemia (AML) that has come back or hasn't responded to treatment. Participants should be suitable for intensive chemotherapy. Specific details about inclusion and exclusion criteria are not provided, but typically these would involve age, previous treatments, and overall health status.

Inclusion Criteria

I am between 18 and 80 years old.

I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.

Participants with history of HCV infection must have undetectable viral load

Exclusion Criteria

My leukemia has spread to my brain or spinal cord.

I had a stem cell transplant from a donor within the last 3 months.

My cancer has a known TP53 mutation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CLAG-M therapy with or without venetoclax

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Venetoclax (BCL2 Inhibitor)

Trial Overview The study tests if adding a drug called Venetoclax to the CLAG-M regimen (a combination of Cladribine, Cytarabine, Mitoxantrone, G-CSF) is safe and more effective than CLAG-M alone in improving outcomes for relapsed or refractory AML patients.

Participant Groups

Group I: CLAG-based therapy with venetoclax Experimental Treatment 2 Interventions

Study participants will receive CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone) and Venetoclax

Group II: CLAG-based therapy without venetoclax Active Control 1 Intervention

Study participants will receive CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Moffitt Cancer Center Tampa, FL

Dana-Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Patients Recruited

145,000+

AbbVie

Industry Sponsor

Trials

1079

Patients Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient initiation of venetoclax in patients with acute myeloid leukemia. Palmer, S., Patel, A., Wang, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax is safe and efficacious in relapsed/refractory AML. Ganzel, C., Ram, R., Gural, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia: The PETHEMA Registry Experience. Labrador, J., Saiz-Rodríguez, M., de Miguel, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective comparison of salvage intensive chemotherapy versus venetoclax-combined regimen in patients with relapsed/refractory acute myeloid leukemia (AML). Park, S., Kwag, D., Kim, TY., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor lysis syndrome risk in outpatient versus inpatient administration of venetoclax and hypomethlators for acute myeloid leukemia. Pelcovits, A., Moore, J., Bakow, B., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Management of the Venetoclax-Treated Patient in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia. Waggoner, M., Katsetos, J., Thomas, E., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. Blair, HA.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]

2. England pubmed.ncbi.nlm.nih.gov

Outpatient initiation of venetoclax in patients with acute myeloid leukemia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Venetoclax is safe and efficacious in relapsed/refractory AML. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia: The PETHEMA Registry Experience. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A retrospective comparison of salvage intensive chemotherapy versus venetoclax-combined regimen in patients with relapsed/refractory acute myeloid leukemia (AML). [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Tumor lysis syndrome risk in outpatient versus inpatient administration of venetoclax and hypomethlators for acute myeloid leukemia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Practical Management of the Venetoclax-Treated Patient in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. [2021]