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| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 5, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | May 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00038818 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation |
| Official Title ICMJE | CD8 DEPLETED DONOR LYMPHOCYTE INFUSIONS FOR PATIENTS WITH RELAPSE OR RESIDUAL DISEASE FOLLOWING ALLOGENEIC STEM CELL TRANSPLANTATION |
| Brief Summary | Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and HD. Secondary Objectives: To evaluate safety and treatment related mortality after CD8 depleted DLI. To evaluate the time to onset of GVHD following DLI and response to GVHD treatment. To evaluate the incidence and timing of pancytopenia following DLI. To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM). To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions. To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells. |
| Detailed Description | Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and HD. Secondary Objectives: To evaluate safety and treatment related mortality after CD8 depleted DLI. To evaluate the time to onset of GVHD following DLI and response to GVHD treatment. To evaluate the incidence and timing of pancytopenia following DLI. To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM). To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions. To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells. |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Procedure: CD8 Depleted Donor Lymphocyte |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | 90 |
| Completion Date | December 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00038818 |
| Responsible Party | |
| Study ID Numbers ICMJE | ID00-335 |
| Study Sponsor ICMJE | M.D. Anderson Cancer Center |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | M.D. Anderson Cancer Center |
| Verification Date | January 2004 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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