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Anti-metabolites

Cladribine plus Venetoclax for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Christine McMahon, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Adequate liver function, as demonstrated by: Aspartate aminotransferase (AST) ≤ 3.0 x ULN, Alanine aminotransferase (ALT) ≤ 3.0 x ULN, Total bilirubin ≤ 1.5 x ULN, unless considered to be due to leukemic organ involvement or Gilbert's syndrome. In subjects with Gilbert's syndrome, bilirubin needs to be ≤ 4 x ULN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 3 years off study

Awards & highlights

Study Summary

This trial is looking at patients who have relapsed or have not responded to treatment for acute myeloid leukemia (AML) with a specific type of AML called monocytic phenotype. The patients have

Who is the study for?

This trial is for adults over 18 with a specific type of Acute Myeloid Leukemia (AML) that hasn't responded to previous treatments. Women must be postmenopausal, surgically sterile, or use contraception; men need to use contraception too. Participants should have an expected lifespan of at least 12 weeks and be physically able enough to do daily activities with some effort.Check my eligibility

What is being tested?

The study tests Cladribine combined with Venetoclax and Azacitidine in patients whose AML has returned or didn't respond after initial treatment. It's specifically for those who've had hypomethylating agents plus Venetoclax before and now have limited options.See study design

What are the potential side effects?

Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, kidney function changes requiring close monitoring, and general fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My liver tests are within normal limits, or slightly elevated due to my condition.

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My leukemia is confirmed as AML without APL, with specific characteristics or mutations.

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I can perform daily activities with minimal assistance.

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My kidneys work well, with a creatinine clearance rate of 60 mL/min or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum of 3 years off study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum of 3 years off study

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 3 years off study for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Adverse Events

Duration of response

Event-free survival

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cladribine plus VenetoclaxExperimental Treatment2 Interventions

Subjects will receive cladribine at a dose of 5mg/m2 daily via intravenous infusion on days 1 through 5 of a 28 day cycle. Concomitantly, venetoclax will be administered orally at a dose of 100mg on day 1, 200mg on day 2, and 400mg daily on days 3 through 28.

Group II: Alternating Aza/Ven and Clad/VenExperimental Treatment3 Interventions

Alternating 28-day consolidation cycles of Aza/Ven (even cycles) and Clad/Ven (odd cycles), while those who do not respond will come off the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Cladribine

2014

Completed Phase 4

~4390

Azacitidine

2012

Completed Phase 3

~1440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Leukemia and Lymphoma SocietyOTHER

82 Previous Clinical Trials

17,091 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,543 Total Patients Enrolled

Christine McMahon, MDPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

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

Are participants still being enrolled in this trial at the moment?

"Based on the information available on clinicaltrials.gov, this particular trial is not currently accepting new participants. The trial was originally posted on December 1st, 2024 and last updated on January 29th, 2024. However, it is worth noting that there are presently a total of 493 other trials actively enrolling patients at this time."

Answered by AI

Has the combination of cladribine and venetoclax received official authorization by the FDA?

"Based on our evaluation, the safety of Cladribine plus Venetoclax is rated as 2 on a scale from 1 to 3. This assessment is due to it being a Phase 2 trial where there is existing data supporting safety but no evidence yet regarding efficacy."

Answered by AI

Do I meet the requirements to participate in this research endeavor?

"To be eligible for this clinical trial, individuals diagnosed with acute myeloid leukemia and aged between 18 to 100 years old are sought after. The study aims to recruit approximately 40 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cladribine Venetoclax in Monocytic AML

2024. "Cladribine Venetoclax in Monocytic AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232655.