Clinical trial · Interventional
Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)
A Prospective Randomized Phase I/II Study of Clofarabine (Clo) and Ara-C vs Clo and Ida vs Clo Plus Ida and Ara-C in Patients With First Relapse or First Salvage of Primary Refractory AML; and High-Grade MDS(>/= 10% Blasts); or CML in Myeloid Blasts Phase as Front Line Therapy or in First Salvage.
- 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)
The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.
Conditions
Conditions (3)
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C 0.75 g/m^2 | Drug | — | UNRESOLVED |
| Ara-C 1 g/m^2 | Drug | — | UNRESOLVED |
| Clofarabine 22.5mg/m^2 | Drug | — | UNRESOLVED |
| Clofarabine 40mg/m^2 | Drug | — | UNRESOLVED |
| Idarubicin 10mg/m^2 | Drug | — | UNRESOLVED |
| Idarubicin 6 mg/m^2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Clofarabine + Ara-C
- description
- Clofarabine 40 mg/m\^2 by vein over 1 hour daily for 5 days. Ara-C Starting dose: 1 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.
- interventionNames
- Drug: Clofarabine 40mg/m^2
- Drug: Ara-C 1 g/m^2
- type
- EXPERIMENTAL
- label
- Clofarabine + Idarubicin
- description
- Clofarabine 22.5 mg/m\^2 by vein over 1 hour daily for 5 days. Idarubicin 10 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.
- interventionNames
- Drug: Idarubicin 10mg/m^2
- Drug: Clofarabine 22.5mg/m^2
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>/= 18 years and \< 60 years. 2. Must be in first relapse of AML, or must receive treatment as first salvage in primary refractory AML; or have high-risk MDS (\>/= 10% blasts) with not more than one prior regimen of chemotherapy (therapy with hematopoietic growth factors, biological or targeted therapies are not counted). Patients in CML myeloid blast phase may receive clofarabine as frontline therapy or in first salvage. 3. Total bilirubin \</= 2mg/dL, Serum glutamic pyruvic transaminase (SGPT) \</= 4 upper limit of normal (ULN), creatinine \</= 2.0mg/dL. 4. Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. 5. Signed informed consent. 6. Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as \>= 1 year postmenopausal or surgically sterilized). Exclusion Criteria: 1. Previous treatment with clofarabine. 2. Active, uncontrolled, systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment, or any severe, concurrent disease, which, in the judgment of the investigator and after discussion with the Principal Investigator, would make the patient inappropriate for study entry. 3. Symptomatic central nervous system (CNS) involvement. 4. Patients who receive other chemotherapy. Patients must have been off previous therapy of \>/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier following discussion with the Principal Investigator. 5. Cardiac ejection fraction \</= 30%.
References
Publications (0)
Data not yet available