Allogeneic Blood Stem Cell Transplantation

NCT00423709 | Completed

• 1 other identifier: DM97-259
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD).
2. 2.To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.
3. 3.To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect.

Conditions

Hodgkin's Disease

Keywords

Hodgkin's Disease; Allogeneic Blood Stem Cell Transplantation; Bone Marrow Transplantation; Fludarabine; Melphalan

Interventions

Allogeneic Blood Stem Cell Transplantation PROCEDURE

Fludarabine DRUG

Melphalan DRUG

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \<65 years of age with histologically confirmed primary refractory or relapsed Hodgkin's disease. In the event of transplants from unrelated donors, the upper age limit will be 55 years.
• Patients who failed or relapsed after an autologous transplant are eligible.
• Patients should have responsive or stable disease on salvage chemotherapy. Patients with untreated, smoldering (i.e. not rapidly progressive) relapses are eligible. Patients who failed or relapsed after an autologous transplant are eligible.
• Patients must have a serum bilirubin \<2.0 mg/dl, serum creatinine \<2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a PS\<2. Life expectancy not severely limited by concomitant illness (\>12 weeks). Left ventricular ejection fraction \>50%.
• Patients must have an HLA-compatible donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells . In the event of transplants from unrelated donors, only fully serologically A-, B- and DR-matched donors (including donors having a single micromismatch by DR/DQ molecular typing) will be acceptable. HLA-compatible cord blood unit will also be acceptable for recipient with a body weight of 50 kg or less.

You may not qualify if:

• Patients with documented disease progression on salvage chemotherapy are not eligible.
• Uncontrolled arrhythmia or symptomatic cardiac disease. FEV1, FVC and DLCO less than 50% . Symptomatic pulmonary disease. Evidence of chronic active hepatitis or cirrhosis.
• Active or uncontrolled infection.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hodgkin Disease

Interventions

fludarabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Paolo Anderlini, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 1998
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

US (1)