Clinical Trial: A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids - Mixed Phenotype Acute Leukemia (MPAL)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, cytarabine, vincristine, and dexamethasone, with or without rituximab, can help to control mixed phenotype acute leukemia. The safety of this combination will also be studied.

Detailed Summary:

Study Drug Administration:

The study drugs will be given in what are called cycles. Each cycle is 28 days.

Induction:

The first cycle of study drugs is called Induction. If the doctor thinks it is needed, you will have up to 2 Induction cycles. During Induction cycles, you will receive:

  • Clofarabine by vein over about 60 minutes on Days 1-4. If the doctor thinks it is in your best interest, you will only receive it on Days 1-3.
  • Idarubicin by vein over about 30-60 minutes on Days 1-3, about 1-2 hours after you receive clofarabine. If the doctor thinks it is in your best interest, you will only receive it on Days 1 and 2.
  • Cytarabine by vein over about 2 hours on Days 1-4, about 3-6 hours after you receive clofarabine.
  • Vincristine by vein over about 15-30 minutes on Days 1, 8, and 15.
  • Dexamethasone by vein over about 10-30 minutes on Days 1-4 and 15-18.
  • If you have a certain type of leukemia and the doctor thinks it is in your best interest, you will also receive rituximab by vein over about 4-6 hours on Days 1 and 8. The study staff will tell you if you will receive rituximab.
  • If you have a certain type of leukemia (AML FLT3-ITD) and the doctor thinks it is in your best interest, you may also receive sorafenib by mouth twice a day for 14 days.

All patients will have at least one lumbar puncture (spinal tap) during the first cycle of induction. This is done to check the status of the disease and to give drugs to help prevent side effec
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome:

  • Response Rate of Newly Diagnosed Mixed Phenotype Acute Leukemia [ Time Frame: 2 months ]
    Response rate defined as complete response (CR) or response as in CR but platelets <100 ×109/L (CRi). Response criteria recommended by the NCI and the MDS International Working Group.
  • Response Rate of Relapsed Mixed Phenotype Acute Leukemia [ Time Frame: 2 months ]
    Response rate defined as complete response (CR) or response as in CR but platelets <100 ×109/L (CRi). Response criteria recommended by the NCI and the MDS International Working Group.


Original Primary Outcome: Response Rate [ Time Frame: 28 days ]

The primary objective is to evaluate the efficacy, with primary endpoint of response. Bone marrow aspirate/biopsy performed at end of first 28 day cycle.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: May 8, 2014
Date Started: October 2014
Date Completion: October 2019
Last Updated: March 28, 2017
Last Verified: March 2017