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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00809276
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : January 19, 2015
Last Update Posted : February 16, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Lymphoma Multiple Myeloma Leukemia Myelodysplastic Syndrome Drug: Busulfan, Fludarabine, Cytoxan Phase 1 Phase 2

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011


Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00809276     History of Changes
Other Study ID Numbers: J0844
NA_00017193 ( Other Identifier: JHMIRB )
First Posted: December 17, 2008    Key Record Dates
Results First Posted: January 19, 2015
Last Update Posted: February 16, 2015
Last Verified: January 2015

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
Transplantation
Busulfan
Fludarabine
Cytoxan
Bone Marrow
Allogeneic
Related donor
unrelated donor

Additional relevant MeSH terms:
Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Cyclophosphamide
Fludarabine phosphate
Busulfan
Fludarabine
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents