Clinical trial · Interventional
Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
NCT02135874CI-TRIAL-00075336completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Bilineal Leukemia | Acute Bilineal Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Biphenotypic Leukemia | Acute Biphenotypic Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Leukemia of Ambiguous Lineage | Acute Leukemia of Ambiguous Lineage | CURATED_BROADER | 0.80 |
| Acute Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| Mixed Phenotype Acute Leukemia | Mixed Phenotype Acute Leukemia | ONTOLOGY_EXACT | 0.98 |
| Mixed Phenotype Acute Leukemia, B/Myeloid, Not Otherwise Specified | Mixed Phenotype Acute Leukemia, B/Myeloid | ONTOLOGY_EXACT | 0.98 |
| Mixed Phenotype Acute Leukemia, T/Myeloid, Not Otherwise Specified |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
| Sorafenib Tosylate | Drug | Sorafenib Tosylate | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (combination chemotherapy)
- description
- See Detailed Description.
- interventionNames
- Drug: Clofarabine
- Drug: Cytarabine
- Drug: Dexamethasone
- Drug: Idarubicin
- Biological: Rituximab
- Drug: Sorafenib
- Drug: Sorafenib Tosylate
- Drug: Vincristine
- Drug: Vincristine Sulfate
Primary outcomes (1)
- measure
- Participants Complete Response
- timeFrame
- Up to 2 months
- description
- Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.