IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00469144
First received: May 3, 2007
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome Leukemia Acute Myeloid Leukemia |
Drug: Busulfan Drug: Fludarabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Study of Once Daily IV Busulfan With Fludarabine With Hemopoietic Stem Cell Transplantation for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Time to failure (TTF) [ Time Frame: From transplant at Day 0 to Day 100 following transplant then quarterly thereafer (3, 6, 12 months) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 230 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fixed-Dose Busulfan + Fludarabine
Busulfan Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
|
Drug: Busulfan
Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily AUC of 6,000 microMol-min ± 10%. 40 mg/m^2 IV Daily Over 1 Hour x 4 Days
|
|
Experimental: Adjusted Dose Busulfan + Fludarabine
Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.
|
Drug: Busulfan
Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily AUC of 6,000 microMol-min ± 10%. 40 mg/m^2 IV Daily Over 1 Hour x 4 Days
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute myeloid leukemia past first remission, in first or subsequent relapse, in first remission (cytogenetics other than t(8;21, inv 16, t(15;17)) or induction failures. Only myeloid leukemia but not biphenotypic leukemia is allowed on this study.
- Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score
- Patient has not been administered any other systemic chemotherapeutic drug (including Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or day -9 for the test-dose arm of the study). Hydroxyurea is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed leptomeningeal disease, that has been in remission for at least 3 months prior to enrollment on this study).
- No active infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved.
- age <=65
- Patients must have a matched related or unrelated donor willing to donate. A donor who is HLA identical or mismatched in 1 locus on Class I [HLA, A or B], or molecularly mismatched in 1 locus on Class II [HLA, DR or DQ] is also acceptable.
- ZUBROD performance status <2
- Life expectancy is not severely limited by concomitant illness and expected to be >12 weeks.
- Left ventricular ejection fraction >45% No uncontrolled arrhythmias or symptomatic cardiac disease.
- No symptomatic pulmonary disease. FEV1, FVC and DLCO >/= 50% of expected corrected for hemoglobin. In patients </= 7 years pulmonary function will be assessed per pediatric BMT routine
- Serum creatinine </= 1.5 mg%.
- SGPT </= 200 IU/ml, serum bilirubin and alkaline phosphatase within accepted laboratory standard normal limits or considered not clinically significant. No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- No effusion or ascites >1L prior to drainage.
- HIV-negative.
- Female patient is not pregnant (negative B-HCG pregnancy test in all women of child-bearing-potential in accordance with departmental routine).
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- No prior autologous stem cell transplants.
Exclusion Criteria: None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469144
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00469144 History of Changes |
| Other Study ID Numbers: | 2005-0366 |
| Study First Received: | May 3, 2007 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Stem Cell Transplantation Leukemia Busulfan |
Fludarabine MDS AML |
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 Busulfan Fludarabine monophosphate Fludarabine Vidarabine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013