A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients with Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
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.
Disease Group: Leukemia
Treatment Agent: 6-mercaptopurine,Clofarabine,Cytarabine,Dexamethasone,Idarubicin,Methotrexate,Prednisone,Rituximab,Vincristine
Treatment Location: Only at MDACC
Primary: To evaluate the response rate of the chemotherapy regimen in patients with mixed phenotype acute leukemia Secondary: To evaluate the durability of response, the overall and event-free survival rates, and the safety profile of the regimen
IRB Review and Approval Date: 10/27/2014
Recruitment Status: Open
Projected Accrual: N/A
1) Sign an informed consent document
2) Age 18 to 80.
3) Newly diagnosed or relapsed 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.
4) ECOG Performance Status of </= 3 at study entry.
5) Adequate organ function as outlined below (unless due to leukemia), Serum creatinine </= 3 mg/dL, Total bilirubin </= 2.5 mg/dL, ALT (SGPT) and/or AST (SGOT) </= 3 x ULN or </= 5 x ULN if related to disease
6) 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.
7) Cardiac ejection fraction >/= 40% (by either cardiac echo or MUGA scan). Documentation of recent (</= 6 months from screening) outside reports is acceptable.
8) 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/m2), for emergency use up to 24 hours prior to start of study therapy is allowed.
1) Breast feeding females
2) Patients with active, uncontrolled infections
3) Patients with active secondary malignancy will not be eligible unless approved by the Principal Investigator.
Information and next steps
For general questions about clinical trials: