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Active Not RecruitingNCT01424982

Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia

Phase II Study of Combination of Hyper-CVAD and Ponatinib in Patients With Philadelphia (PH) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
88 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the clinical efficacy (event-free survival) of an intensive short-term chemotherapy regimen (hyperfractionated cyclophosphamide-vincristine sulfate-Adriamycin \[doxorubicin hydrochloride\]-dexamethasone \[hyper-CVAD\] program) given in combination with the tyrosine kinase inhibitor ponatinib hydrochloride (ponatinib) for Philadelphia (Ph)-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL). II. To evaluate other clinical efficacy endpoints (overall response rate and survival) and safety of the regimen. OUTLINE: ODD CYCLES (1, 3, 5, and 7): Patients receive cyclophosphamide intravenously (IV) over 3 hours every 12 hours on days 1-3, doxorubicin hydrochloride IV continuously over 24 hours on day 4, vincristine sulfate IV over 30 minutes on days 1 and 11, dexamethasone IV over 30 minutes or orally (PO) once daily (QD) on days 1-4 and 11-14, and ponatinib hydrochloride PO QD on days 1-14 of cycle 1 and continuously in cycles 3, 5, and 7. Patients with CD20 expression may also receive rituximab IV on days 1 and 11 of cycle 1 and 3. Treatment repeats every 3-4 weeks for up to 8 cycle in the absence of disease progression or unacceptable toxicity. EVEN CYCLES (2, 4, 6, and 8): Patients receive methotrexate IV over 24 hours on day 1, ponatinib hydrochloride PO QD continuously, and cytarabine IV over 3 hours every 12 hours on days 2 and 3. Patients with CD20 expression may also receive rituximab IV on days 1 and 8 of cycle 2 and 4. Treatment repeats every 3-4 weeks for up to 8 cycle in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive vincristine sulfate IV on day 1, prednisone PO daily on days 1-5, and ponatinib hydrochloride PO QD on days 1-28. Cycle repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 24 months.

Conditions

Interventions

TypeNameDescription
DRUGCyclophosphamideGiven IV
DRUGCytarabineGiven IV
DRUGDexamethasoneGiven IV or PO
DRUGDoxorubicinGiven IV
DRUGDoxorubicin HydrochlorideGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGMethotrexateGiven IV
DRUGPonatinibGiven PO
DRUGPonatinib HydrochlorideGiven PO
DRUGPrednisoneGiven PO
BIOLOGICALRituximabGiven IV
DRUGVincristineGiven IV
DRUGVincristine SulfateGiven IV

Timeline

Start date
2011-10-05
Primary completion
2027-10-31
Completion
2027-10-31
First posted
2011-08-29
Last updated
2026-04-15

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01424982. Inclusion in this directory is not an endorsement.