Clinical Trial: Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation

Brief Summary:

RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.

Detailed Summary:

OBJECTIVES:

• Determine 180-day survival in patients with malignant or nonmalignant hematologic diseases treated with allogeneic umbilical cord blood transplantation. (Severe aplastic anemia, Fanconi anemia, and marrow failure syndromes strata are closed to accrual; adult [over 18 years of age] patient stratum is closed to accrual.)
• Determine disease-free and long-term survival in patients treated with this regimen.
• Determine the incidence of neutrophil engraftment, primary and secondary graft failure, platelet engraftment, and red blood cell engraftment in patients treated with this regimen.
• Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
• Determine the incidence of complications, including infection, veno-occlusive disease, and interstitial pneumonitis, in patients treated with this regimen.
• Determine the incidence of relapse, other malignancies, lymphoproliferative disorders, and posttransplantation myelodysplasia in patients treated with this regimen.
• Determine the immune reconstitution in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are grouped according to the following strata:

• Stratum I: Malignant disease, 5/6 or 6/6 HLA match, age 18 and under
• Stratum II: Malignant disease, 4/6 HLA match, age 18 and under
• Stratum III: Malignant disease, 3/6 HLA match, age 18 and under
• Stratum IV:
  Sponsor: Roswell Park Cancer Institute
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Roswell Park Cancer Institute
  

  Dates:
  Date Received: March 6, 2003
  Date Started: January 2003
  Date Completion:
  Last Updated: March 3, 2011
  Last Verified: March 2011