Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00143845|
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : June 20, 2014
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Lymphocytic Leukemia, Chronic Lymphoma, Low-Grade||Procedure: Reduced intensity conditioning Procedure: Rapid immunosuppressive taper Procedure: Prophylactic donor leukocyte infusions||Phase 2|
In this research study patients will receive dosages of chemotherapy that are lower than the usual dosages. The study will determine whether a shorter duration of immunosuppression will permit the donor cells to be effective against the cancer without causing more severe GVHD (Graft Versus Host Disease). Also to be determined is whether the patient's cancer can be prevented from relapsing after blood stem cell transplant by using prophylactic treatment, giving a donor leukocyte infusion BEFORE a relapse happens.
In this research study samples of blood and bone marrow will be analyzed. These samples will be examined to study the cellular production of inflammatory cytokine levels in attempt to be able to predict which patients will have complications like GVHD or relapse.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Reduced Intensity Allogeneic Stem Cell Transplantation|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||February 2013|
Experimental: Immunosuppression Taper
Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
Procedure: Reduced intensity conditioning
Busulfan and Fludarabine regimenProcedure: Rapid immunosuppressive taper
Taper of Tacrolimus, Methotrexate and Mycophenolate MofetilProcedure: Prophylactic donor leukocyte infusions
If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.
- Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4 [ Time Frame: 100 days ]
The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows:
Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement
- Percentage of Participants With Progression Free Survival [ Time Frame: two years ]
The second primary objective was to determine the percentage of participants with progression free survival following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.
We define disease progression as disease recurrence within 180 days of transplant.
- Percentage of Patients Alive at 2 Years [ Time Frame: 2 Years ]To estimate the overall survival of patients progression following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143845
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||John E. Levine, MD, MS||The Univeristy of Michigan|