Cyclophosphamide Plus Transplantation of Partially HLA-mismatched, CD8+ T Cell-depleted Peripheral Blood Cells for Patients With Myelodysplastic Syndrome , Refractory Acute Myeloid Leukemia, Refractory Lymphoma or Myeloproliferative Disorders
|ClinicalTrials.gov Identifier: NCT00356928|
Recruitment Status : Active, not recruiting
First Posted : July 27, 2006
Last Update Posted : July 13, 2017
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of abnormal blood cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in the laboratory may be an effective treatment for myelodysplastic syndromes or myeloproliferative disorders.
PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given together with cyclophosphamide in treating patients with myelodysplastic syndromes or myeloproliferative disorders.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Biological: donor lymphocytes Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide||Not Applicable|
- Determine the maximum tolerated dose of allogeneic CD8-positive T-cell-depleted, haploidentical donor lymphocytes when given after cyclophosphamide in patients with myelodysplastic syndromes or myeloproliferative disorders.
OUTLINE: Patients receive cyclophosphamide on days 1 and 2. Patients then undergo infusion of allogeneic T-cell depleted donor lymphocytes on day 3.
Cohorts of patients receive escalating doses of CD8-positive T-cell-depleted haploidentical donor lymphocytes until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cyclophosphamide Plus Transplantation of Partially HLA-Mismatched (Haploidentical), CD8+ T Cell-Depleted Peripheral Blood Cells (PBCs) for Patients With Myelodysplastic (MDS) or Myeloproliferative Disorders (MPD)|
|Study Start Date :||May 2006|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
- Maximum tolerated dose of CD8-positive T-cell-depleted haploidentical donor lymphocytes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356928
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Yvette L. Kasamon, MD||Sidney Kimmel Comprehensive Cancer Center|