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

NCT02135874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-22

Study results available
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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.

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Elias Jabbour · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-27
Primary Completion
2023-02-21
Completion
2023-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135874 on ClinicalTrials.gov