NCT00354120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

6.4 years

First QC Date

July 19, 2006

Last Update Submit

March 9, 2023

Conditions

Acute Myeloblastic LeukemiaLymphoblastic LeukemiaMyelodysplasiaChronic Myeloid LeukemiaMyelofibrosisLympho-proliferative Diseases

Outcome Measures

Primary Outcomes (5)

  • 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

  • Acute and chronic GvHD

    3 years

Secondary Outcomes (5)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Alentuzumab

Drug: Alentuzumab

2

ACTIVE COMPARATOR

Globulina antilinfocitaria

Drug: Globulina antilinfocitaria

Interventions

AlentuzumabDRUG

Alentuzumab

1
Globulina antilinfocitariaDRUG

Globulina antilinfocitaria

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

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

Alessandria, Italy

Location

Clinica di Ematologia - Ospedali Riuniti di Ancona

Ancona, Italy

Location

Divisione di Ematologia - Ospedali Riuniti Bergamo

Bergamo, Italy

Location

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

Cuneo, Italy

Location

Cattedra di Ematologia - Azienda Ospedaliera di Careggi

Florence, Italy

Location

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

Genova, Italy

Location

Divisione di Ematologia - Istituto Nazionale dei Tumori

Milan, Italy

Location

U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena

Milan, Italy

Location

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -

Modena, Italy

Location

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

Monza, Italy

Location

Divisione Ematologia con trapianto - Ospedale "V. Cervello"

Palermo, Italy

Location

Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia

Pavia, Italy

Location

Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara

Pescara, Italy

Location

Ematologia - Ospedale S. Chiara

Pisa, Italy

Location

Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli

Reggio Calabria, Italy

Location

Cattedra di Ematologia - Università La Sapienza

Roma, Italy

Location

Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli

Roma, Italy

Location

U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni

Roma, Italy

Location

Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas

Rozzano (MI), Italy

Location

Ematologia 2 - ASO San Giovanni Battista

Torino, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaAnemia, Refractory, with Excess of BlastsLeukemia, Myelogenous, Chronic, BCR-ABL PositivePrimary Myelofibrosis

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAnemia, RefractoryAnemiaMyelodysplastic SyndromesBone Marrow DiseasesMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alessandro Rambaldi, MD

    Divisione di Ematologia - Ospedali Riuniti di Bergamo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

March 1, 2005

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

IT(22)