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Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies
This study is currently recruiting participants.
Verified by Stanford University, May 2008
Sponsors and Collaborators: Stanford University
National Institutes of Health (NIH)
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00185640
  Purpose

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.


Condition Intervention Phase
Blood Cancer
Procedure: nonmyeloablative allogeneic hematopoietic cell transplant
Phase II

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.

Secondary Outcome Measures:
  • To evaluate the incidence and extent of chronic GVHD.
  • To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells.
  • To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate.
  • To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.

Estimated Enrollment: 90
Study Start Date: March 2003
Detailed Description:

Allogeneic Hematopoietic Cell Transplantation using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients with Hematologic Malignancies

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:(A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxsymal Nocturnal Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.

(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.

(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.

(D) Patient must be competent to give consent. Exclusion Criteria:(A) Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.

(B) Uncontrolled CNS involvement with disease

(C) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment

(D) Females who are pregnant

(E) Organ dysfunction defined as follows:

  • Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
  • Pulmonary: DLCO <40% predicted
  • Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
  • Renal: creatinine clearance <50 cc/min (24 hour urine collection)

(F) Karnofsky performance score < 60%

(G) Patients with poorly controlled hypertension on multiple antihypertensives

(H) Documented fungal disease that is progressive despite treatment

(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis

(J) Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185640

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: BMT Referrals     650-723-0822     cctoffice@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Robert Lowsky            
Sub-Investigator: Karl G. Blume            
Sub-Investigator: Richard T. Hoppe            
Sub-Investigator: Laura Johnston            
Sub-Investigator: Robert S Negrin            
Sub-Investigator: Judith Anne Shizuru            
Sub-Investigator: Samuel Md Strober            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert Lowsky Stanford University
  More Information

Study ID Numbers: BMT153, BMT153, NCT00185640
Study First Received: September 12, 2005
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00185640  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antilymphocyte Serum
Hematologic Neoplasms
Hematologic Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009