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

Recruiting in Palo Alto (17 mi)

Overseen by Elias Jabbour

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Sign an informed consent document

Eastern Cooperative Oncology Group (ECOG) performance status of =< 3 at study entry

Serum creatinine =< 3 mg/dL

Exclusion Criteria

Breast feeding females

Patients with active secondary malignancy will not be eligible unless approved by the principal investigator

You have an ongoing infection that is not under control.

Treatment Details

Interventions

• Clofarabine (Anti-metabolites)
• Cytarabine (Anti-metabolites)
• Dexamethasone (Corticosteroid)
• Idarubicin (Anti-tumor antibiotic)
• Rituximab (Other)
• Sorafenib (Other)
• Sorafenib Tosylate (Other)
• Vincristine (Vinca alkaloids)

Participant Groups

Group I: Treatment (combination chemotherapy) Experimental Treatment 9 Interventions

See Detailed Description.

Clofarabine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Clolar for:

• Acute lymphoblastic leukemia (ALL) in pediatric patients

🇪🇺 Approved in European Union as Evoltra for:

• Acute lymphoblastic leukemia (ALL) in pediatric patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References