← Back to Search

DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine and DLI for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Antonio M Jimenez Jimenez, MD

Research Sponsored by Antonio M Jimenez Jimenez

Eligibility Criteria Checklist

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

Must have

Male and female patients between the ages of 18-75

Patients with a histologic diagnosis of AML in morphological remission (<5% bone marrow (BM) blasts) prior to allogeneic hematopoietic cell transplantation and very high-risk for relapse

Must not have

Active uncontrolled systemic fungal, bacterial, or viral infection

Active disease (>5% blasts or any evidence of extra-medullary disease) at the time of transplantation or at day +30

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination treatment to reduce AML relapse risk after hematopoietic cell transplant in high-risk patients.

Who is the study for?

This trial is for adults aged 18-75 with high-risk AML in remission, who've had a cell transplant and are at risk of relapse. They must have stable blood counts, good organ function, and no active infections or severe heart issues. Women must not be pregnant, and there should be no recent other cancers.

What is being tested?

The study tests a combination treatment using venetoclax, azacitidine, and donor lymphocyte infusion (DLI) on patients with high-risk AML post-cell transplant to see if it's safe and can prevent the cancer from coming back.

What are the potential side effects?

Potential side effects may include immune system reactions due to DLI, low blood counts leading to bleeding or infection risks from chemotherapy agents like venetoclax and azacitidine, as well as possible liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 75 years old.

Select...

I have AML in remission with a high risk of relapse and less than 5% bone marrow blasts.

Exclusion Criteria

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

Select...

I do not have any ongoing serious infections.

Select...

My disease is active, with signs of it outside the bone marrow or more than 5% blasts.

Select...

I have severe graft-versus-host disease or am being treated for it.

Select...

I am currently on medication for ongoing chronic GVHD.

Select...

I do not have an active infection with HIV, HBV, or HCV.

Select...

I have not had serious heart problems in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Experiencing Treatment-Related Toxicity

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Number of Participants with acute GVHD After Allogeneic Hematopoietic Cell Transplant (HCT)

Number of Participants with chronic GVHD After Allogeneic Hematopoietic Cell Transplant (HCT)

Overall Survival (OS)

+2 more

Awards & Highlights

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: VEN/AZA Expansion CohortExperimental Treatment3 Interventions

Participants in this group will receive VEN/AZA therapy at the most appropriate dose determined in Part 1. Participants may also receive donor lymphocyte infusions (DLI) at the discretion of the treating physician, if certain criteria are met. Participants will receive up to one year (12 cycles) of study therapy, followed by up to one year of follow-up. Total participation duration is up to two years.

Group II: VEN/AZA Dose Escalation/De-Escalation CohortExperimental Treatment3 Interventions

Participants in this group will begin Venetoclax and Azacitidine (VEN/AZA) combination therapy between day +42 and day +100 following hematopoietic cell transplant (HCT) infusion. VEN/AZA combination therapy will be administered for up to six (6) cycles, followed by up to six (6) additional cycles of Venetoclax monotherapy in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days. Participants may also receive donor lymphocyte infusions (DLI) at the discretion of the treating physician, if certain criteria are met. Participants will receive up to one year (12 cycles) of study therapy, followed by up to one year of follow-up. Total participation duration is up to two years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Azacitidine

2012

Completed Phase 3

~1440