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Study Summary
No. 2008-0261:.......Hematologic Disorder; Leukemia; Lymphoma; Myeloma......Amin Alousi......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:		2008-0261
Study Title:Busulfan (IV) and Fludarabine followed by post-allogeneic transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in patients with hematologic malignancies.
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Physician New Patient Referral
Name:Amin AlousiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:Hematologic Disorder
Leukemia
Lymphoma
Myeloma		Supported By:N/A
Phase of Study:Phase IIReturn
Visit:		While an outpatient and for the first 100 days following transplant, patients
will be required to come to clinic a minimum of 2 times per week. After the
first 100 days, visits are at 3, 6, 9, 12, 18 and 24 months following the date
of transplant.
Treatment
Agents:		Busulfan
Cyclophosphamide
Fludarabine
Mesna		Home Care:No anticipated home treatment.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Approximate 1 month hospital stay. Patients are required to stay in Houston
for the first 100 days following transplant. Patients will then be seen every
3-6months thereafter for 2 years from the date of transplant.
Description/
Intervention:		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.
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Study Objectives / Outcomes
1.1 Primary

To determine the safety of the conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) followed by post-transplantation Cyclophosphamide (Cy) after allogeneic stem cell transplantation from Human Leukocyte Antigen (HLA) identical related or unrelated donors.

To determine the incidence of grade II-IV and III-IV acute Graft versus Host Disease (GVHD) when employing post-transplantation Cy as GVHD prophylaxis.

1.2 Secondary
        Assess engraftment.

        Incidence of Chronic GVHD at 1 year.

        Progression-free survival at 1 year.

        Overall survival at 1 year.
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    Study Status Information
    Study Activation / Registration Date:09/02/2008
    IRB Review and Approval Date:09/02/2008
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Open
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse.

    2) HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.

    3) Age 6 months to 75 years.

    4) Bilirubin </= 1.5 mg/dl, SGPT </= 200 IU/ml (unless Gilbert's syndrome).

    5) 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.

    6) 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.

    7) LVEF >/= 35%.
    Exclusion Criteria:1) HIV seropositivity

    2) Uncontrolled infections.

    3) Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization

    4) Inability to sign consent
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    Links
    Registration Number: NCT00800839
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center