NCT02135874

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well clofarabine, idarubicin, cytarabine, vincristine sulfate, and dexamethasone work in treating patients with mixed phenotype acute leukemia that is newly diagnosed or has returned after a period of improvement (relapsed). Drugs used in chemotherapy, such as clofarabine, idarubicin, cytarabine, vincristine sulfate, 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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the response rate of the chemotherapy regimen in patients with mixed phenotype acute leukemia. SECONDARY OBJECTIVE: I. To evaluate the durability of response, the overall and event-free survival rates, and the safety profile of the regimen. OUTLINE: INDUCTION THERAPY: Patients receive clofarabine intravenously (IV) over 60 minutes on days 1-4 or 1-3; idarubicin IV over 30-60 minutes on days 1-3 or 1-2; cytarabine IV over 2 hours on days 1-4; vincristine sulfate IV over 15-30 minutes on days 1, 8, and 15; and dexamethasone IV over 10-30 minutes on days 1-4 and 15-18. Patients with a certain type of leukemia may receive rituximab IV over 4-6 hours on days 1 and 8 or sorafenib tosylate orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients receive clofarabine IV over 60 minutes on days 1-3 or 1-2; idarubicin IV over 30-60 minutes on days 1-2; cytarabine IV over 2 hours on days 1-3 or 1-2; vincristine sulfate IV over 15-30 minutes on days 1, 8, and 15; and dexamethasone IV over 10-30 minutes on days 1-4 and 15-18. Patients with a certain type of leukemia may receive rituximab IV over 4-6 hours on days 1 and 8 of cycles 1-3 or sorafenib tosylate PO BID on days 1-28 of cycle 1-6 and beyond. Treatment repeats every 28 days for up to 6 cycles 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 thereafter.

Conditions

• Acute Bilineal Leukemia
• Acute Biphenotypic Leukemia
• Acute Leukemia of Ambiguous Lineage
• Acute Undifferentiated Leukemia
• Mixed Phenotype Acute Leukemia
• Mixed Phenotype Acute Leukemia, B/Myeloid, Not Otherwise Specified
• Mixed Phenotype Acute Leukemia, T/Myeloid, Not Otherwise Specified
• Recurrent Mixed Phenotype Acute Leukemia

Interventions

Type	Name	Description
DRUG	Clofarabine	Given IV
DRUG	Cytarabine	Given IV
DRUG	Dexamethasone	Given IV
DRUG	Idarubicin	Given IV
BIOLOGICAL	Rituximab	Given IV
DRUG	Sorafenib	Given PO
DRUG	Sorafenib Tosylate	Given PO
DRUG	Vincristine	Given IV
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2014-10-27
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2014-05-12
• Last updated: 2024-03-22
• Results posted: 2024-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study