Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00800839
First received: December 1, 2008
Last updated: April 14, 2014
Last verified: April 2014
  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 2015 (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:
  • Bulsulfex™
  • Myleran®
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:
  • 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:

  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 Cockcroft-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, NCI-2012-01660
Study First Received: December 1, 2008
Last Updated: April 14, 2014
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
Lymphoma
Leukemia
Hematologic Diseases
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Cyclophosphamide
Busulfan
Fludarabine phosphate
Fludarabine
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014