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Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation


Phase 2
15 Years
61 Years
Not Enrolling
Both
Chronic Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplasia, Acute Lymphocytic Leukemia, Severe Aplastic Anemia, Non-Hodgkin's Lymphoma, Lymphoproliferative Disease, Multiple Myeloma, Advanced Myeloproliferative Disease

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Trial Information

Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation


Inclusion Criteria:



- No fully or single-antigen mismatched sibling donor is available to donate stem
cells.

- Age >15 and <61

- ECOG PS < or equal to 2

- Adequate renal function with serum creatinine <2.0 mg/dl

- Pulmonary diffusing capacity >40% of predicted

- Cardiac ejection fraction >40% as measured by radionuclide wall motion study or
echocardiography

- No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline
phosphatase and AST must be less than three times the upper limit of normal. Patients
with hepatitis C and active hepatitis B are eligible only if a liver biopsy is
performed and there is < or equal to grade 2 inflammation. Patients wtih a history of
HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative).
Patients with active HBV viral replication should receive anti-viral therapy.

- Negative serology for the human immunodeficiency virus (HIV)

- Available HLA-matched donor (see HLA compatibility requirements below)

- Signed informed consent from the recipient

Exclusion Criteria:

- Ongoing active infection

- Pregnancy and/or nursing

- Active, uncontrolled CNS leukemia

- Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the
preferable form of treatment

- Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or
imatinib mesylate. Use of interferon within 3 months of starting therapy.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thomas G. Martin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: UCSF Cancer Center Data Safety Monitoring Committee

Study ID:

UC-2214

NCT ID:

NCT00516152

Start Date:

November 2002

Completion Date:

November 2007

Related Keywords:

  • Chronic Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • Myelodysplasia
  • Acute Lymphocytic Leukemia
  • Severe Aplastic Anemia
  • Non-Hodgkin's Lymphoma
  • Lymphoproliferative Disease
  • Multiple Myeloma
  • Advanced Myeloproliferative Disease
  • Matched Unrelated Donor
  • Stem Cell Transplantation
  • Busulfan
  • fludarabine
  • Hematopoietic Disorder
  • Anemia
  • Anemia, Aplastic
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders

Name

Location

University of California San FranciscoSan Francisco, California  941104206