NCT00516152

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 26, 2009

Status Verified

January 1, 2009

First QC Date

August 13, 2007

Last Update Submit

January 22, 2009

Conditions

Chronic Myeloid LeukemiaAcute Myelogenous LeukemiaMyelodysplasiaAcute Lymphocytic LeukemiaSevere Aplastic AnemiaNon-Hodgkin's LymphomaLymphoproliferative DiseaseMultiple MyelomaAdvanced Myeloproliferative Disease

Keywords

Matched Unrelated DonorStem Cell TransplantationBusulfanfludarabineHematopoietic Disorder

Interventions

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

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

Eligibility Criteria

Age15 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of BlastsPrecursor Cell Lymphoblastic Leukemia-LymphomaAnemia, AplasticLymphoma, Non-HodgkinLymphoproliferative DisordersMultiple Myeloma

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, RefractoryAnemiaMyelodysplastic SyndromesLeukemia, LymphoidLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow Failure DisordersLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Thomas G. Martin, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

November 1, 2002

Study Completion

November 1, 2007

Last Updated

January 26, 2009

Record last verified: 2009-01

Locations

US(1)