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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02135874
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clofarabine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given IV
  • Idarubicin — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV
  • Sorafenib — DRUG
    Given PO
  • Sorafenib Tosylate — DRUG
    Given PO
  • Vincristine — DRUG
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Oct 27, 2014
Status verified
Mar 2024
Primary completion
Feb 21, 2023
Completion
Feb 21, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (combination chemotherapy)
    See Detailed Description.

Primary Outcome Measure

Participants Complete Response [ Time Frame: Up to 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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