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Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies

Multiple Myeloma Clinical Trial

Official title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies

Clinical Trial Summary

This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in adults with high-risk hematopoietic malignancies. A novel myeloablative preparative regimen will be used. One, up to a maximum of three cord blood units will be administered to facilitate engraftment.

Clinical Trial Description

This study intends to demonstrate an engraftment rate of >80% at day 100 post-transplantation and a transplant related mortality rate of < or equal to 50%. A TRM of >50% will be considered unacceptable. The present research will also:

- Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy prior to umbilical cord blood cell transplantation.

- Evaluate neutrophil and platelet recovery following UCB transplantation.

- Evaluate lineage-specific chimerism following transplantation and to assess the contribution of each individual CB unit to post-transplantation hematopoiesis.

- Evaluate event free and overall survival.

- Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB transplantation. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • Hematologic Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Multiple Myeloma
  • Myelodysplasia
  • Myelodysplastic Syndromes
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • T-NK Cell Lymphoma
Clinical Trial Details
NCT number NCT00514722
Study type Interventional
Source University of California, San Francisco
Contact
Status Terminated
Phase N/A
Start date October 2002
Completion date March 2009
View Details
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