HJKC3-0003 = TFR After Asciminib Based Therapy in CP CML Patients Who Relapsed After Previously Stopping TKI [USA]
Study title
Treatment Free Remission After Asciminib Based Therapy in Chronic Phase CML Patients Who Relapsed After Prior TKI Discontinuation
Scientific title
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib (ABL001) Based Therapy 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
Current status
Recruiting
Other trial ID
PRO00040685; ClinicalTrials.gov NCT04838041
What is the purpose of the study
This is a study to assess if asciminib based therapy can help patients achieve treatment-free remission (TFR) who relapsed after a first treatment-free remission attempt.
What will happen during the study
This study incudes patients with a confirmed diagnosis of chronic phase CML who 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.
Eligible patients will begin asciminib with or without a TKI on cycle 1 day 1 of the consolidation phase. They will continue therapy for a total of 12 cycles (minimum of 12 months). Each cycle will be about 28 days. At the end of 12 cycles, asciminib with or without TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt.
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 without BCR::ABL1 mutation T315I but with 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 or switch to asciminib for at least 12 months during the consolidation 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
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
Contact: 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
Contact: Srinivas Tantravahi, MBBS
Wisconsin
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Contact: Ehab Atalah, MD