Phase 2
N=151
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Leukemia · AML · MDS · CML
Bottom Line
View on ClinicalTrials.gov: NCT01019317 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Participants With a Complete Response — 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cytarabine (Drug); Fludarabine (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Complete Response |
34 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Sign an Internal Review Board (IRB)-approved informed consent document.
- Age >/= 12 years.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
- 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.
- 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
- Pregnant or breastfeeding females.
- Diagnosis of acute promyelocytic leukemia (M3).
Data sourced from ClinicalTrials.gov (NCT01019317). 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.