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Epigenetic Modifier

Venetoclax Combination Therapy for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow

Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by specific laboratory values

Must not have

Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded

Plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new way to treat AML with drugs and chemo, to help patients have a better response.

Who is the study for?

This trial is for AML patients who've relapsed or didn't respond to initial treatments. They must have recovered from previous therapies, have no severe infections or GVHD if post-transplant, and meet specific organ function criteria. Pregnant women can't participate, and contraception is required for those of childbearing potential.

What is being tested?

The study tests adding venetoclax to azacitidine and vorinostat before standard chemo in AML patients. The goal is to improve treatment response by combining these drugs with chemotherapy agents like cytarabine and fludarabine.

What are the potential side effects?

Potential side effects include nausea, diarrhea, low blood cell counts leading to increased infection risk, fatigue, liver issues, and possible allergic reactions. Venetoclax may also interact with other drugs affecting its dosage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AML is detectable in my bone marrow.

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My kidney and liver tests are within normal ranges.

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I am not taking any drugs that affect CYP3A4 enzyme activity.

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I am mostly able to carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a genetic disorder like Fanconi anemia.

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I plan to receive other cancer treatments not listed in the study during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Venetoclax Dose-Limiting Toxicity

Secondary study objectives

MRD

Response Rates

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: AML without Down SyndromeExperimental Treatment6 Interventions

The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC \> 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42

Group II: AML with Down SyndromeExperimental Treatment6 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

FDA approved

Azacitadine

2016

Completed Phase 3

~360

Fludarabine