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DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine and DLI for Acute Myeloid Leukemia

Q: Is this investigation recruiting elderly participants?

The age requirements of this trial are from 18 to 75. There are 473 studies that cater exclusively to minors while 1247 focus on people who have surpassed the retirement age.

Q: What qualifications make an individual suitable for this experiment?

Eligibility for this medical research necessitates that patients have acute myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and are between the ages of 18-75. The total number of participants currently being recruited is 25.

Q: Are medical professionals currently accepting new patients for this experiment?

According to clinicaltrials.gov, the last enrollment date for this medical trial has already passed and it is no longer actively recruiting individual patients. The study was initially posted in February of 2024 and was most recently updated on November 27th 2023; however, there are still 1559 other trials currently enrolling participants at this time.

Q: To what extent can VEN/AZA Dose Escalation/De-Escalation Cohort be detrimental to individuals?

The safety of VEN/AZA Dose Escalation/De-Escalation Cohort is provisionally rated a 1 since this trial is in the Phase 1 stage, meaning data collected so far has been limited.

Q: What objectives is this research endeavor attempting to realize?

The purpose of this 13-month trial is to measure the amount of treatment-related toxicity among participants. Secondary goals include using elapsed time between treatment start date and death from any cause to calculate Overall Survival, calculating Treatment-Related Mortality as a proportion of those who died after beginning therapy, and counting the number with Chronic GVHD post Allogeneic Hematopoietic Cell Transplantation (HCT).

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am between 18 and 75 years old.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Experiencing Treatment-Related Toxicity

Recommended Phase 2 Dose (RP2D)

Secondary outcome measures

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

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

~1990

Azacitidine

2012

Completed Phase 3

~1440

Donor Lymphocyte Infusion

1995

Completed Phase 2

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

954 Previous Clinical Trials

501,019 Total Patients Enrolled

Antonio M Jimenez JimenezLead Sponsor

Antonio M Jimenez Jimenez, MDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation recruiting elderly participants?

"The age requirements of this trial are from 18 to 75. There are 473 studies that cater exclusively to minors while 1247 focus on people who have surpassed the retirement age."

Answered by AI

What qualifications make an individual suitable for this experiment?

"Eligibility for this medical research necessitates that patients have acute myeloid leukemia and are between the ages of 18-75. The total number of participants currently being recruited is 25."

Answered by AI

Are medical professionals currently accepting new patients for this experiment?

"According to clinicaltrials.gov, the last enrollment date for this medical trial has already passed and it is no longer actively recruiting individual patients. The study was initially posted in February of 2024 and was most recently updated on November 27th 2023; however, there are still 1559 other trials currently enrolling participants at this time."

Answered by AI

To what extent can VEN/AZA Dose Escalation/De-Escalation Cohort be detrimental to individuals?

"The safety of VEN/AZA Dose Escalation/De-Escalation Cohort is provisionally rated a 1 since this trial is in the Phase 1 stage, meaning data collected so far has been limited."

Answered by AI

What objectives is this research endeavor attempting to realize?

"The purpose of this 13-month trial is to measure the amount of treatment-related toxicity among participants. Secondary goals include using elapsed time between treatment start date and death from any cause to calculate Overall Survival, calculating Treatment-Related Mortality as a proportion of those who died after beginning therapy, and counting the number with Chronic GVHD post Allogeneic Hematopoietic Cell Transplantation (HCT)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Antonio M Jimenez Jimenez 2024. "Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158100.