Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

Phase 2

Completed

• Conditions: Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Chronic Myeloid Leukemia; Lympho-proliferative Diseases; Myelodysplasia; Myelofibrosis
• Interventions: Drug: Globulina antilinfocitaria; Drug: Alentuzumab

• Registration Number: NCT00354120
• Lead Sponsor: Gruppo Italiano Trapianto di Midollo Osseo

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-20
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Globulina antilinfocitaria	Globulina antilinfocitaria
1	Alentuzumab	Alentuzumab

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 years
Safety:	3 years
Event Free Survival and Disease Free Survival	3 years
Major infective complications (CMV and EBV related PTLD)	3 years
Acute and chronic GvHD	3 years

Secondary Outcome Measures

Name	Time	Method
Haematological and immunologic reconstitution	3 years
Incidence of CMV and EBV reactivation	3 years
Other toxicities	3 years
Need for DLI	3 years
Other infective complications	3 years

Trial Locations

Locations (22)

Clinica di Ematologia - Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino; 🇮🇹 Genova, Italy

Divisione di Ematologia - Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Ematologia - Ospedale S. Chiara; 🇮🇹 Pisa, Italy

Divisione di Ematologia - Ospedali Riuniti Bergamo; 🇮🇹 Bergamo, Italy

Cattedra di Ematologia - Azienda Ospedaliera di Careggi; 🇮🇹 Firenze, Italy

Divisione Ematologia con trapianto - Ospedale "V. Cervello"; 🇮🇹 Palermo, Italy

Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano; 🇮🇹 Monza, Italy

Cattedra di Ematologia - Università La Sapienza; 🇮🇹 Roma, Italy

U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena; 🇮🇹 Milano, Italy

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -; 🇮🇹 Modena, Italy

Ematologia 2 - ASO San Giovanni Battista; 🇮🇹 Torino, Italy

Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli; 🇮🇹 Reggio Calabria, Italy

Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"; 🇮🇹 Alessandria, Italy

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle; 🇮🇹 Cuneo, Italy

Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia; 🇮🇹 Pavia, Italy

Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara; 🇮🇹 Pescara, Italy

Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas; 🇮🇹 Rozzano (MI), Italy

Clinica Ematologica - Policlinico Universitario; 🇮🇹 Udine, Italy

Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli; 🇮🇹 Roma, Italy

U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni; 🇮🇹 Roma, Italy