Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (NCT00354120) | Clinical Trial Compass
CompletedPhase 2/3
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Italy121 participantsStarted 2005-03
Plain-language summary
The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual)
* Group 2: patients \<= 65 yo suffering from lympho-proliferative diseases according the REAL classification:
* High-doses chemotherapy relapsed CLL (B and T)
* Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy
* Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy
* Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy
* Advanced (stage ≥ III A) or relapsed T lymphomas
* Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens
* Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy
* Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells.
Exclusion Criteria:
* Performance status \< 70% (Karnofsky)
* Left ventricular cardiac ejection fraction \< 40% or receiving treatment for heart failure
* …
What they're measuring
1
Overall Survival
Timeframe: 3 years
2
Event Free Survival and Disease Free Survival
Timeframe: 3 years
3
Safety:
Timeframe: 3 years
4
Major infective complications (CMV and EBV related PTLD)