Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
This study is not yet open for participant recruitment.
Verified by Sidney Kimmel Comprehensive Cancer Center, December 2008
Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
M.D. Anderson Cancer Center
Fred Hutchinson Cancer Research Center
Otsuka Pharmaceutical Co., Ltd.
Information provided by: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00809276
  Purpose

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


Condition Intervention Phase
Lymphoma
Multiple Myeloma
Leukemia
Myelodysplastic Syndrome
Drug: Busulfan, Fludarabine, Cytoxan
Phase I
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma
Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
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

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 ]

Estimated Enrollment: 90
Study Start Date: January 2009
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 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

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809276

Locations
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.
Investigators
Study Chair: Leo Luznik, MD Johns Hopkins University
  More Information

Responsible Party: Sydney Kimmel Comprehensive Cancer center ( Leo Luznik, MD )
Study ID Numbers: J0844, JHM IRB # NA_00017193
Study First Received: December 16, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00809276  
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
Hemetologic Malignancies
Transplantation
Busulfan
Flidaeabine
Cytoxan
Bone Marrow
Allogeneic
Related donor
unrelated donor

Study placed in the following topic categories:
Leukemia, Lymphoid
Hodgkin's disease
Chronic myelogenous leukemia
Precancerous Conditions
Chronic myelomonocytic leukemia
Blood Protein Disorders
Lymphoma, small cleaved-cell, diffuse
Paraproteinemias
Cyclophosphamide
Leukemia, Myeloid, Acute
Hemostatic Disorders
Leukemia
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Acute myelocytic leukemia
Hodgkin Disease
Lymphoma
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Myelodysplasia
Myelodysplastic Syndromes
Acute myelogenous leukemia
Myeloproliferative Disorders
Vascular Diseases
Fludarabine monophosphate

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009