Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04838041

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Led by Medical College of Wisconsin · Updated on 2025-07-30

51

Participants Needed

4

Research Sites

398 weeks

Total Duration

On this page

Sponsors

M

Medical College of Wisconsin

Lead Sponsor

H

H. Jean Khoury Cure CML Consortium

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.

CONDITIONS

Official Title

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Diagnosed with chronic phase chronic myeloid leukemia (CML) without BCR::ABL1 T315I mutation
  • Must have one prior documented attempt to discontinue a TKI under physician guidance
  • Stable molecular response (MR4; < 0.01% IS) for more than 2 years with at least four PCR tests
  • Treated with FDA-approved TKIs (imatinib, dasatinib, or nilotinib) for about 3 years before stopping
  • No resistance to any TKI, only intolerance allowed
  • Relapsed after first TKI discontinuation defined as loss of major molecular response (BCR::ABL1 > 0.1% IS)
  • Retreated with TKI for at least 1 year after relapse and plan to continue same TKI or switch to asciminib for 12 months
  • Current TKI is the same as prior to initial stop attempt
  • ECOG performance status 0 to 3
  • PCR for BCR::ABL1 < 0.0032% IS at enrollment
  • Lipase ≤ 1.5 times upper limit of normal without risk for pancreatitis
  • eGFR ≥ 30 mL/min using CKD-EPI formula
  • Female participants must be postmenopausal, surgically sterile, or use two effective contraception methods, or true abstinence
  • Male participants must use effective barrier contraception or true abstinence during treatment and 90 days after
Not Eligible

You will not qualify if you...

  • History of accelerated or blast phase CML
  • Active second cancer requiring treatment
  • Acute or chronic pancreatitis within past 12 months
  • Previous treatment with asciminib
  • Platelet count < 100 x 10^9/L, neutrophil count < 1 x 10^9/L, or hemoglobin < 8 g/dL
  • AST or ALT ≥ 3 times upper limit of normal
  • Total bilirubin ≥ 1.5 times upper limit of normal unless direct bilirubin normal
  • Pregnant or breastfeeding
  • Unable to comply with lab visits and patient assessments
  • Use of other investigational drugs within 4 weeks
  • Serious medical or psychiatric illness interfering with treatment
  • Prior allogeneic stem cell transplant
  • Baseline ECG with QTc > 480 msec (or > 500 msec with pacemaker)
  • Known active hepatitis B infection
  • Must have completed 12 cycles of consolidation therapy and meet molecular response criteria to enter treatment-free remission phase

AI-Screening

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Trial Site Locations

Total: 4 locations

1

The Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

2

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

3

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Actively Recruiting

4

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

M

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

E

Ehab Atallah, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

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