Active — Not RecruitingPhase 2

The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation

China93 participantsStarted 2020-07-09

Plain-language summary

This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with CP-CML
✓. Be previously treated with and resistant or intolerant to either Dasatinib or Nilotinib:
✓. Develop the T315I mutation after any TKI therapy;
✓. Must be ≥18 years old.
✓. Provide written informed consent.
✓. Eastern Cooperative Oncology Group performance status ≤ 2.
✓. Minimum life expectancy of 3 months or more.
✓. Adequate renal function

✕. Received TKI therapy within 7 days prior to receiving the first dose of Ponatinib, or have not recovered (\> grade 2 by NCI CTCAE v5.0) from AEs (except alopecia) due to agents previously administered.
✕. Received other therapies (excluding hydroxyurea) as follows:
✕. Underwent autologous or allogeneic stem cell transplant \< 60 days prior to receiving the first dose of Ponatinib;
✕. Take medications that are known to be associated with Torsades de Pointes or QT interval prolongation.
✕. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
✕. Have previously been treated with Ponatinib or its analogues (including drug substance).
✕. Patients with CP-CML are excluded if they are in CCyR.
✕. Have active central nervous system (CNS) disease, as evidenced by cytology or pathology.

MCyR(Major Cytogenetic Response) of CP-CML patients

Timeframe: 12 months

MaHR(Major Hematologic Response) of AP-CML, BP-CML and Ph+ ALL patients by 6 months

Timeframe: 6 months

NCT IDNCT04233346

SponsorOtsuka Beijing Research Institute

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-22

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with CP-CML
✓. Be previously treated with and resistant or intolerant to either Dasatinib or Nilotinib:
✓. Develop the T315I mutation after any TKI therapy;
✓. Must be ≥18 years old.
✓. Provide written informed consent.
✓. Eastern Cooperative Oncology Group performance status ≤ 2.
✓. Minimum life expectancy of 3 months or more.
✓. Adequate renal function

✕. Received TKI therapy within 7 days prior to receiving the first dose of Ponatinib, or have not recovered (\> grade 2 by NCI CTCAE v5.0) from AEs (except alopecia) due to agents previously administered.
✕. Received other therapies (excluding hydroxyurea) as follows:
✕. Underwent autologous or allogeneic stem cell transplant \< 60 days prior to receiving the first dose of Ponatinib;
✕. Take medications that are known to be associated with Torsades de Pointes or QT interval prolongation.
✕. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
✕. Have previously been treated with Ponatinib or its analogues (including drug substance).
✕. Patients with CP-CML are excluded if they are in CCyR.
✕. Have active central nervous system (CNS) disease, as evidenced by cytology or pathology.