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

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Brief Title

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

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

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response (complete response or overall response rate)

Secondary Outcome

 4-week mortality rate (Newly diagnosed patients)

Condition

Acute Bilineal Leukemia

Intervention

Clofarabine

Study Arms / Comparison Groups

 Treatment (combination chemotherapy)
Description:  See Detailed Description.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

October 27, 2014

Completion Date

December 31, 2034

Primary Completion Date

December 31, 2034

Eligibility Criteria

        Inclusion Criteria:

          -  Sign an informed consent document

          -  Newly diagnosed or relapsed mixed phenotype acute leukemia (MPAL), which for this
             protocol, will be defined as follows: bone marrow result interpreted by the reading
             pathologist (or tissue biopsy for cases of extramedullary disease) as: biphenotypic
             leukemia, bilineal leukemia, undifferentiated leukemia, mixed lineage leukemia,
             leukemia of ambiguous lineage, T/myeloid leukemia, B/myeloid leukemia, or other
             diagnosis indicating the presence of multiple lineages within the cell population

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

          -  Adequate organ function as outlined below (unless due to leukemia)

          -  Serum creatinine =< 3 mg/dL

          -  Total bilirubin =< 2.5 mg/dL

          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and/or
             aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3
             x upper limit of normal (ULN) or =< 5 x ULN if related to disease

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days; women of childbearing potential and men must agree to use contraception
             at study entry and for the duration of active study treatment

          -  Cardiac ejection fraction >= 40% (by either cardiac echocardiogram [echo] or multi
             gated acquisition [MUGA] scan); documentation of recent (=< 6 months from screening)
             outside reports is acceptable

          -  If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single
             or a two day dose of cytarabine (up to 3 g/m^2), for emergency use up to 24 hours
             prior to start of study therapy is allowed

        Exclusion Criteria:

          -  Breast feeding females

          -  Patients with active, uncontrolled infections

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elias Jabbour, 713-792-4764, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02135874

Organization ID

2013-0073

Secondary IDs

NCI-2014-02322

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Elias Jabbour, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

April 2021