Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01019317
First received: November 23, 2009
Last updated: September 7, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control AML, MDS, or CML in myeloid blast crisis. The safety of this drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia AML MDS CML |
Drug: Cytarabine Drug: Fludarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Patients Response Rate [ Time Frame: Following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7). Cycle is 4-6 weeks. ] [ Designated as safety issue: Yes ]
| Enrollment: | 151 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cytarabine + Fludarabine
Fludarabine 15 mg/m2 IV every 12 hours x 5 days; Cytarabine 0.5 grams/m2 IV over 2 hours every 12 hours x 5 days.
|
Drug: Cytarabine
0.5 grams/m2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients > 65 years and 3 days in patients with PS > 3).
Other Names:
Drug: Fludarabine
15 mg/m2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients > 65 years and 3 days in patients with PS > 3).
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Sign an 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.
- 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. ALT (SGPT) </= 5 x ULN or </= 10 x 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019317
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Elias Jabbour, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01019317 History of Changes |
| Other Study ID Numbers: | 2009-0781 |
| Study First Received: | November 23, 2009 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Acute Myelogenous Leukemia High-Risk Myelodysplastic Syndrome Chronic myeloid leukemia CML Blast crisis Cytarabine Ara-C Cytosar |
DepoCyt Cytosine arabinosine hydrochloride Arabinosine Hydrochloride Fludarabine Fludarabine Phosphate Fludara Gemtuzumab Ozogamicin Mylotarg |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cytarabine Fludarabine monophosphate Vidarabine |
Fludarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013