Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT02115295

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Led by M.D. Anderson Cancer Center · Updated on 2025-11-06

508

Participants Needed

1

Research Sites

836 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

CONDITIONS

Official Title

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute myeloid leukemia, acute biphenotypic leukemia, high-risk myelodysplastic syndrome, or myeloid blast phase of chronic myeloid leukemia
  • No prior potentially curative therapy for leukemia for frontline group; some prior therapies like hydroxyurea or low-dose cytarabine allowed
  • For salvage group, previously treated, relapsed, or refractory AML, biphenotypic leukemia, or myeloid blast phase CML
  • Age 18 to 65 years
  • Adequate liver, kidney, and heart function as defined by specific laboratory and clinical measures
  • Performance status of 2 or less on the ECOG scale
  • Negative pregnancy test within 1 week for women of childbearing potential
  • Ability to understand study requirements and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Uncontrolled illnesses including active infections, severe heart failure, unstable angina, significant arrhythmias, or psychiatric/social conditions limiting study compliance
  • Known allergy to any chemotherapy components used in this study
  • Men and women of childbearing potential who do not agree to use contraception before and during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

T

Tapan Kadia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia | DecenTrialz