CML ADVOCATES NETWORK

Clinical Trials

HJKC3-0003 = TFR After Asciminib Plus TKI in CP CML Patients Who Relapsed After Previously Stopping TKI [USA]

Study title

Treatment Free Remission After Combination Therapy With Asciminib Plus TKI in Chronic Phase CML Patients Who Relapsed After Prior TKI Discontinuation

Scientific title

Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Type of study

Treatment discontinuation trial

Phase

2

Current status

Recruiting

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Other trial ID

PRO00040685; ClinicalTrials.gov NCT04838041

What is the purpose of the study

This is a study to assess if combination therapy with a TKI plus asciminib can help patients achieve treatment-free remission who relapsed after a first treatment-free remission attempt.

What will happen during the study

Eligible patients will be treated with asciminib in combination with a TKI for about 12 months. At the end of the combination therapy phase, asciminib will be discontinued and any patient who has met the criteria for the treatment free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, patients will also discontinue their TKI and be closely monitored for 3 years in the TFR phase plus one year long-term follow-up.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older.
  • have been diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants.
  • have a documented history of attempting to discontinue one prior TKI (dasatinib, imatinib or nilotinib) under the guidance of a treating physician.
  • must have relapsed (defined as loss of major molecular response) after first attempted TKI discontinuation.
  • must have restarted the same TKI they were on prior to discontinuation at the time of relapse, must have been on that TKI for at least one year, and must plan to remain on that TKI for at least 12 months during the combination treatment phase.
  • have stable molecular response, defined as MR4.5, at the time of study enrollment.

To be eligible for attempting treatment free remission (TFR) in this study, patients:

  • have stable molecular response (MR4.5) documented on at least three tests by the trial designated lab, performed approximately three months apart while receiving asciminib plus TKI during the combination phase.
  • have MR4.5 at TFR phase screening.
  • have an Eastern Co-Operative Group (ECOG) status of 0, 1, 2, or 3.
  • have completed the combination therapy phase.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have a history of accelerated or blast phase CML.
  • have a second malignancy requiring active treatment.
  • have had acute pancreatitis or chronic pancreatitis within the last 12 months.
  • have previously received treatment with asciminib.
  • previously undergone allogeneic stem cell transplant.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

June 2028

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Medical College of Wisconsin
in collaboration with
H. Jean Khoury Cure CML Consortium

Scientific lead / contact

Michael J. Mauro, MD,
Memorial Sloan Kettering Cancer Center

Principal investigator

Ehab Atallah, MD,
Medical College of Wisconsin

Study centers / principal investigators

United States

Michigan

The Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Principal Investigator: Jay Yang, MD

New York

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Principal Investigator: Michael Mauro, MD

Utah

Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Wisconsin

Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Principal Investigator: Ehab Atalah, MD