Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.

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Key information

Conditions

Chronic Myeloid Leukemia Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Advanced Myeloproliferative Disease Anemia Anemia, Aplastic Anemia, Refractory Anemia, Refractory, with Excess of Blasts Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Cardiovascular Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disease Lymphoproliferative Disorders Multiple Myeloma Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin's Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Severe Aplastic Anemia Vascular Diseases

Age range

15 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF

Drug

Day Preparative Regimen for GVHD Prophylaxis

7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
3 Fludarabine 30 mg/m(2)IV
2 REST Tacrolimus 0.01 mg/kg CIVI
1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion

1 Methotrexate 5mg/m(2)IV
3 Methotrexate 5mg/m(2)IV
6 Methotrexate 5mg/m(2)IV
7 G-CSF 5mcg/kg SQ daily
11 Methotrexate 5mg/m(2)IV
90 Evaluate Response

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2007
First posted: Aug 15, 2007
Registry last updated: Jan 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed