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

Conditions

• Chronic Phase Chronic Myelogenous Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Asciminib 40 MG — DRUG
  40 mg by mouth (PO) when used with imatinib.
• Asciminib 40 MG Twice Daily — DRUG
  40 mg twice daily when used with nilotinib.
• Asciminib 80 MG daily — DRUG
  80 mg daily when used with dasatinib or taken alone.
• Imatinib — DRUG
  Maximum dose of 400 mg PO once daily.
• Nilotinib — DRUG
  Maximum dose of 300 mg twice daily.
• Dasatinib — DRUG
  Maximum dose of 100 mg PO once daily.

Study Details

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.

Key Dates

Start date

Nov 11, 2021

Status verified

Jul 2025

Primary completion

Jun 30, 2028

Completion

Jul 31, 2029

Study Design

Enrollment

51 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Asciminib 40 mg PO daily plus imatinib (maximum dose of 400 mg PO once daily)
  All eligible patients will begin asciminib plus/minus 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 \~28 days. At the end of 12 cycles, asciminib plus/minus TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt.
• Experimental: Asciminib 40 mg twice daily plus nilotinib (maximum dose of 300 mg twice daily)
  All eligible patients will begin asciminib plus/minus 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 \~28 days. At the end of 12 cycles, asciminib plus/minus TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt.
• Experimental: Asciminib 80 mg daily plus dasatinib (maximum dose of 100 mg PO once daily)
  All eligible patients will begin asciminib plus/minus 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 \~28 days. At the end of 12 cycles, asciminib plus/minus TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt.
• Experimental: Asciminib 80 mg PO daily taken alone
  All eligible patients will begin asciminib plus/minus 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 \~28 days. At the end of 12 cycles, asciminib plus/minus TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt.

Primary Outcome Measure

One-year "second" treatment-free remission. [ Time Frame: 1 year after stopping treatment ]

Central Contacts

• Medical College of Wisconsin Cancer Center Clinical Trials Office
  414-805-8900
  [email protected]
• Ehab Atallah, MD
  414-805-4600
  [email protected]

Locations (4)

Find similar trials in Detroit, MI

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