Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00800839

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 II

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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia Lymphoma Multiple Myeloma

Drug Information available for: Cyclophosphamide Busulfan Fludarabine Fludarabine monophosphate

U.S. FDA Resources

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 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Busulfan + Fludarabine + Cyclophosphamide	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: Bulsulfex™ Myleran® Drug: Fludarabine Dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before you receive busulfan. Other Names: Fludarabine Phosphate Fludara Drug: Cyclophosphamide Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4. Other Names: Cytoxan® Neosar®

Arms

Assigned Interventions

Experimental: Busulfan + Fludarabine + Cyclophosphamide

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:

Bulsulfex™
Myleran®

Drug: Fludarabine

Dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before you receive busulfan.

Other Names:

Fludarabine Phosphate
Fludara

Drug: Cyclophosphamide

Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.

Other Names:

Cytoxan®
Neosar®

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:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

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:	December 13, 2011
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®
Bulsulfex™
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 February 09, 2012