Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Trapianto di Midollo Osseo
• Treatments: Alemtuzumab

Criteria

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

• DLCO pulmonary < 40% or receiving continuous oxygen therapy

• Neuropathy (previous or at present)

• Pregnancy

• Patients with arterial hypertension not controlled with multi-pharmacological treatments

• HIV positive

• B-CLL with clear evidence of transformation into Richter syndrome

• Mycosis fungoides with clear evidence of transformation into blasts

• Hodgkin's disease refractory to chemotherapy

• Absence of informed consent

• Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment