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Acute Myeloblastic LeukemiaPhase 2/3GLOBALNCT00354120

Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

A Phase 2/3 study testing Alentuzumab and Globulina antilinfocitaria in people with Acute Myeloblastic Leukemia and Lymphoblastic Leukemia, run by Gruppo Italiano Trapianto di Midollo Osseo at 22 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Alentuzumab and Globulina antilinfocitaria
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
22 sitesItaly
Study dates
Mar 2005to Aug 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Italy22 sites

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

    Alessandria

  • Clinica di Ematologia - Ospedali Riuniti di Ancona

    Ancona

  • Divisione di Ematologia - Ospedali Riuniti Bergamo

    Bergamo

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

    Cuneo

  • Cattedra di Ematologia - Azienda Ospedaliera di Careggi

    Florence

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

    Genova

  • Divisione di Ematologia - Istituto Nazionale dei Tumori

    Milan

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

    Milan

  • Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -

    Modena

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

    Monza

  • Divisione Ematologia con trapianto - Ospedale "V. Cervello"

    Palermo

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

    Pavia

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

    Pescara

  • Ematologia - Ospedale S. Chiara

    Pisa

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

    Reggio Calabria

  • Cattedra di Ematologia - Università La Sapienza

    Roma

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

    Roma

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

    Roma

  • Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas

    Rozzano (MI)

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

    San Giovanni Rotondo, Foggia, 71013

  • Ematologia 2 - ASO San Giovanni Battista

    Torino

  • Clinica Ematologica - Policlinico Universitario

    Udine

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Alentuzumab, Globulina antilinfocitaria
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlentuzumabDrug

    Alentuzumab

  • Globulina antilinfocitariaDrug

    Globulina antilinfocitaria

Study groups in NCT00354120
Study groupRoleWhat they receive
1ExperimentalAlentuzumab
Receives: Drug: Alentuzumab
2Active comparatorGlobulina antilinfocitaria
Receives: Drug: Globulina antilinfocitaria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 3 years

  2. Event Free Survival and Disease Free Survival

    Measured: 3 years

  3. Safety:

    Measured: 3 years

  4. Major infective complications (CMV and EBV related PTLD)

    Measured: 3 years

  5. Acute and chronic GvHD

    Measured: 3 years

Secondary outcomes (5)

  1. Haematological and immunologic reconstitution

    Measured: 3 years

  2. Incidence of CMV and EBV reactivation

    Measured: 3 years

  3. Other infective complications

    Measured: 3 years

  4. Other toxicities

    Measured: 3 years

  5. Need for DLI

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2006 (estimated)
  2. Study startMar 2005
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354120
Sponsor's protocol ID
EudraCT:2005-000805-68
Acronym
GLOBAL
Status last verified
Mar 2023
First submitted
19 Jul 2006
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Alentuzumab and Globulina antilinfocitaria in people with Acute Myeloblastic Leukemia and Lymphoblastic Leukemia, run by Gruppo Italiano Trapianto di Midollo Osseo at 22 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00354120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.

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