Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

This study has been completed.
M.D. Anderson Cancer Center
Fred Hutchinson Cancer Research Center
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: December 16, 2008
Last updated: January 27, 2012
Last verified: January 2012

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Condition Intervention Phase
Multiple Myeloma
Myelodysplastic Syndrome
Drug: Busulfan, Fludarabine, Cytoxan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine the optimal regimen of post-graft immunosuppression with high-dose Cy following fludarabine, busulfan, and transplantation of fully HLA-matched bone marrow that leads to an acceptable incidence of grades III/IV acute GVHD. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 95
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Busulfan, Fludarabine, Cytoxan

    Busulfan once a day for 4 days

    Fludarabine once a day for 4 days

    Bone marrow transplant

    Cytoxan two doses

    Other Names:
    • BMT
    • Cyclophosphamide
    • Allogeneic
    • Transplantation
Detailed Description:

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)

However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT


Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ages between 0 to and 65 years of age.
  • Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
  • Acute lymphocytic leukemia (ALL) in CR1 with high risk features
  • Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

    i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]

  • Acute Leukemias in 2nd or greater remission
  • Refractory or Relapsed AML
  • AML transformed from MDS
  • Myelodysplastic syndrome (MDS) beyond refractory anemia
  • Chronic myeloid leukemia (CML)
  • Chronic myelomonocytic leukemia
  • Philadelphia-negative myeloproliferative disorder
  • Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
  • Multiple Myeloma-Stage III

Exclusion Criteria:

  • Prior autologous or allogeneic stem cell transplant.
  • Performance status greater than 2
  • Active infection.
  • Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
  • Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
  • Inadequate Serum creatinine clearance <60
  • InadequatebHepatic function
  • Positive serology for HIV-1, 2 or HTLV-1, 2.
  • Pregnancy. Female patient must have negative pregnancy test
  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 identifier: NCT00809276

United States, Maryland
The Sydney Kimmel Comprehensive Cancer center
Baltimore, Maryland, United States, 21231
United States, Texas
Marcos deLima, MD
Houston, Texas, United States, 77030
United States, Washington
Paul V. O'Donnell, M.D., Ph.D.
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
M.D. Anderson Cancer Center
Fred Hutchinson Cancer Research Center
Otsuka Pharmaceutical Co., Ltd.
Study Chair: Leo Luznik, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00809276     History of Changes
Other Study ID Numbers: J0844, NA_00017193
Study First Received: December 16, 2008
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Acute lymphocytic leukemia (ALL)
Acute myeloid leukemia (AML)
Acute Leukemia
Refractory or Relapsed AML
Myelodysplastic syndrome (MDS)
Chronic myeloid leukemia (CML)
Chronic myelomonocytic leukemia
Hodgkin's Lymphoma
Non-Hodgkin's lymphoma
Philadelphia-negative myeloproliferative disorder
Hematologic Malignancies
Bone Marrow
Related donor
unrelated donor

Additional relevant MeSH terms:
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Vascular Diseases
Fludarabine phosphate
Alkylating Agents
Antimetabolites processed this record on November 20, 2014