Phase 2
N=16
Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
Acute Bilineal Leukemia · Acute Biphenotypic Leukemia · Acute Leukemia of Ambiguous Lineage · Acute Undifferentiated Leukemia · Mixed Phenotype Acute Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02135874 ↗Enrolled (actual)
16
Serious AEs
68.8%
Results posted
Mar 2024
Primary outcome: Primary: Participants Complete Response — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clofarabine (Drug); Cytarabine (Drug); Dexamethasone (Drug); Idarubicin (Drug); Rituximab (Biological); Sorafenib (Drug); Sorafenib Tosylate (Drug); Vincristine (Drug); Vincristine Sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Complete Response |
9 | — |
| SECONDARY 4-week Mortality Rate |
1 | — |
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.
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 = = 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
Data sourced from ClinicalTrials.gov (NCT02135874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.