Acute Myeloblastic Leukemia, Chronic Myeloid Leukemia, Lymphoblastic Leukemia, Lympho-proliferative Diseases, Myelodysplasia, Myelofibrosis
Conditions
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 donors.
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 rationale to use RIC regimens is based on the observation that the infusion of alloreactive donor lymphocytes may yield to a graft versus tumour effect. However, in this kind of regimens the morbidity and TRM due to GvHD are still a concern and in vivo T-depletion is a necessary treatment. Both monoclonal (Alemtuzumab) and polyclonal T-depletion protocols carry risks and benefits. Benefits being a better prophylaxis for GvHD, and risks being an higher incidence of post-transplantation infections and relapse. At the moment, it is not clear which type of regimen, monoclonal or polyclonal, is better for the treatment.
Interventions
DRUGAlentuzumab
Alentuzumab
DRUGGlobulina antilinfocitaria
Globulina antilinfocitaria
Sponsors
Gruppo Italiano Trapianto di Midollo Osseo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute and chronic GvHD | 3 years |
| Overall Survival | 3 years |
| Event Free Survival and Disease Free Survival | 3 years |
| Safety: | 3 years |
| Major infective complications (CMV and EBV related PTLD) | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and immunologic reconstitution | 3 years |
| Incidence of CMV and EBV reactivation | 3 years |
| Other infective complications | 3 years |
| Other toxicities | 3 years |
| Need for DLI | 3 years |
Countries
Italy
Outcome results
None listed