Status:
COMPLETED
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Lead Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Conditions:
Acute Myeloblastic Leukemia
Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 d...
Detailed Description
The reduction of intensity of conditioning is currently indicated for patients who cannot undergo standard myelo-ablation due to their age, comorbidities or type of pathology. Furthermore, the rationa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00354120
Start Date
March 1 2005
End Date
August 1 2011
Last Update
March 10 2023
Active Locations (22)
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1
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
2
Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"
Alessandria, Italy
3
Clinica di Ematologia - Ospedali Riuniti di Ancona
Ancona, Italy
4
Divisione di Ematologia - Ospedali Riuniti Bergamo
Bergamo, Italy