Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
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:
NCT00800839
First received: December 1, 2008
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 cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Diseases Leukemia Lymphoma Myeloma |
Drug: Busulfan Drug: Fludarabine Drug: Cyclophosphamide |
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: | Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies. |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Incidence of Grade III to IV Acute GVHD and Non-relapse Mortality [ Time Frame: 30 days post transplant ] [ Designated as safety issue: Yes ]Evaluations between first 25-35 days post transplant, and every 3 months up to a year, then followed up to 2 years.
| Estimated Enrollment: | 55 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Busulfan + Fludarabine + Cyclophosphamide
Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
Drug: Busulfan
Starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.
Other Names:
Drug: Fludarabine
Dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.
Other Names:
Drug: Cyclophosphamide
Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Months to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse.
- HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
- Age 6 months to 75 years.
- Bilirubin </= 1.5 mg/dl, SGPT </= 200 IU/ml (unless Gilbert's syndrome).
- Calculated creatinine clearance of >50mL/min using the Cockroft-Gault equation for adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6 months to 17 years old.
- Diffusing capacity for carbon monoxide (DLCO) >45% predicted corrected for hemoglobin (as reported by the Pulmonary Function Laboratory at MDACC). For most children </= 6 years of age who are unable to perform PFT, pulse oximetry >/= 92% on room air.
- LVEF >/= 35%.
Exclusion Criteria:
- HIV seropositivity
- Uncontrolled infections.
- Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
- Inability to sign consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800839
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: | Amin Alousi, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00800839 History of Changes |
| Other Study ID Numbers: | 2008-0261 |
| Study First Received: | December 1, 2008 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Post-allogeneic transplantation Graft-versus-Host Disease Prophylaxis Graft-versus-Host Disease GVHD Hematologic malignancies Leukemia Lymphoma Myeloma Human Leukocyte Antigen HLA |
Busulfan Cyclophosphamide Fludarabine Mesna Cytoxan® Neosar® Busulfex Myleran® Fludarabine Phosphate |
Additional relevant MeSH terms:
|
Graft vs Host Disease Hematologic Diseases Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Hematologic Neoplasms Immune System Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Neoplasms by Site Busulfan Cyclophosphamide Fludarabine monophosphate Fludarabine Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 19, 2013