A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax … (NCT05268003) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
Stopped: \< 75% participation
United States4 participantsStarted 2022-06-07
Plain-language summary
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants with relapsed or refractory T-cell acute lymphoblastic leukemia defined as receiving one or more cytotoxic containing regimens and A. Bone marrow involvement with ≥ 5% lymphoblasts B. Age ≥ 12 Years and greater than 40kg
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
✓. Adequate organ function
✓. Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
✓. Participants must provide written informed consent
Exclusion criteria
✕. Participant is pregnant or breastfeeding
✕. Participants under 40kg
✕. Participants with uncontrolled active infection
✕. Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
✕. Major surgery or radiation therapy within 4 weeks prior to the first study dose
What they're measuring
1
To determine the complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax.
Timeframe: through study completion, an average of 1 year
. Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea, dexamethasone, or one dose of cytarabine) prior to starting therapy
✕. No clinical, radiological or laboratory evidence of pancreatitis, including: