Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)

Gruppo Italiano Trapianto di Midollo Osseo

Status and phase

Completed

Phase 3

Phase 2

Conditions

Myelofibrosis

Lymphoblastic Leukemia

Acute Myeloblastic Leukemia

Chronic Myeloid Leukemia

Myelodysplasia

Lympho-proliferative Diseases

Treatments

Drug: Globulina antilinfocitaria

Drug: Alentuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00354120

EudraCT:2005-000805-68

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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