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Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

Information source: Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloblastic Leukemia; Lymphoblastic Leukemia; Myelodysplasia; Chronic Myeloid Leukemia; Myelofibrosis; Lympho-proliferative Diseases

Intervention: Alentuzumab (Drug); Globulina antilinfocitaria (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Gruppo Italiano Trapianto di Midollo Osseo

Official(s) and/or principal investigator(s):
Alessandro Rambaldi, MD, Study Chair, Affiliation: Divisione di Ematologia - Ospedali Riuniti di Bergamo

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.

Clinical Details

Official title: Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Overall Survival

Event Free Survival and Disease Free Survival

Safety:

Major infective complications (CMV and EBV related PTLD)

Acute and chronic GvHD

Secondary outcome:

Haematological and immunologic reconstitution

Incidence of CMV and EBV reactivation

Other infective complications

Other toxicities

Need for DLI

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Clinica di Ematologia - Ospedali Riuniti di Ancona, Ancona, Italy

Divisione di Ematologia - Ospedali Riuniti Bergamo, Bergamo, Italy

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

Cattedra di Ematologia - Azienda Ospedaliera di Careggi, Firenze, Italy

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

Divisione di Ematologia - Istituto Nazionale dei Tumori, Milano, 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

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

Divisione Ematologia con trapianto - Ospedale "V. Cervello", Palermo, 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

Ematologia - Ospedale S. Chiara, Pisa, Italy

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

Cattedra di Ematologia - Università La Sapienza, Roma, 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

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

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza, S. Giovanni Rotondo (FG), Italy

Ematologia 2 - ASO San Giovanni Battista, Torino, Italy

Clinica Ematologica - Policlinico Universitario, Udine, Italy

Additional Information

Starting date: March 2005
Last updated: March 20, 2014

Page last updated: August 23, 2015

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