Clinical trial · Interventional
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
NCT01019317CI-TRIAL-00021361completedPhase 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)
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CML | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytarabine + Fludarabine
- description
- Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.
- interventionNames
- Drug: Cytarabine
- Drug: Fludarabine
Primary outcomes (1)
- measure
- Participants With a Complete Response
- timeFrame
- Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)
- description
- Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign an Internal Review Board (IRB)-approved informed consent document. 2. Age \>/= 12 years. 3. Diagnosis of AML \[other than acute promyelocytic leukemia (APL)\] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or high by IPSS or \>/=10% blasts) MDS will also be eligible. Patients with chronic myeloid leukemia (CML) in blast crisis will be eligible as well. 4. Eastern Cooperative Oncology Group (ECOG) performance status of \</= 3 at study entry. 5. Organ function as defined below (unless due to leukemia): i. Serum creatinine \</= 3 mg/dL; ii. Total bilirubin \</= 3 mg/dL; iii. Alanine aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) \</= 5 times upper limit of normal (ULN) or \</= 10 times ULN if related to disease. 6. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days . Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Exclusion Criteria: 1. Pregnant or breastfeeding females. 2. Diagnosis of acute promyelocytic leukemia (M3).
References
Publications (0)
Data not yet available
No reference posted for this study.