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LeukemiaPhase 2AlloTreoNCT00598624

Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

A Phase 2 study testing Treosulfan IV in people with Leukemia and Chronic Myeloid Leukemia, run by IRCCS San Raffaele at 12 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies. Read more about this study

Who is it for?
Ages 18 to 69 years
What is being tested?
Treosulfan IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
12 sitesItaly
Study dates
Sep 2005to Dec 2010
Phase
Phase 2
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with haematological malignancies, according to WHO classification, such as:
  • acute myeloid leukaemia -AML- in CR1 except "low-risk cases" defined by t(15;17), t(8;21), inv 16 or normal cytogenetics at diagnosis with FLT3-ITD negative and NPM-1 positive, with no high risk clinical criteria
  • any AML beyond CR1
  • acute lymphoblast leukaemia -ALL- in CR1 only if at "high risk" defined by cytogenetics as t(9;22), t(4;11) or for persistence of minimal residual disease (MRD)
  • any ALL beyond CR1
  • chronic myeloid leukaemia -CML- in chronic phase (CP) or accelerated phase (AP) intolerant/not responsive to TK-inhibitors
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  • myeloproliferative disorders -MPD-
  • myelodysplastic syndrome -MDS- with intermediate or high risk International Prognostic Scoring System (IPSS)
  • diffuse large cell lymphoma -DLCL- with a chemosensitive relapse or beyond CR1
  • lymphoblastic and Burkitt lymphoma with a chemosensitive relapse or beyond CR1
  • mantle cell lymphoma -MCL- with a chemosensitive relapse or beyond CR1
  • follicular lymphoma -FCL- with a chemosensitive relapse or beyond CR2
  • Hodgkin lymphoma -HD- with a chemosensitive relapse or beyond CR1
  • chronic lymphocytic leukaemia -CLL- at "poor risk" in CR1 or with a chemosensitive relapse
  • CLL relapsing after high dose chemotherapy
  • T-cell non Hodgkin lymphoma -T-NHL- in CR1 or beyond
  • multiple myeloma -MM- at high risk for cytogenetics or ISS stage 3 in CR1 following high dose chemotherapy
  • MM at any relapse/progression except refractory disease
  • Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD)
  • HLA-identity defined by the following markers: A, B, DRB1, DQB1 or a single or double Cord Blood unit (CB) with at least a 4 out of 6 HLA-matching by the following markers: A, B and DRB.
  • identity between the 2 CB units and the recipient;
  • Two identical CB units with one or two mismatches with the recipient;
  • Two CB units with one mismatch between them and two mismatches with the recipient. We will prefer mismatches either for class I or for class II antigens; we will avoid mismatches concerning both classes I and II together.
  • Target graft size (unmanipulated, preferably not cryopreserved)
  • bone marrow: 2 to 10 x 106 CD34+ cells/kg BW recipient or > 2 x 108 nucleated cells/kg BW recipient or
  • peripheral blood: 4 to 10 x 106 CD34+ cells/kg BW recipient
  • Age > 18 and < 70 years
  • Karnofsky Index > 80 %
  • Adequate contraception in female patients of child-bearing potential
  • Written informed consent

Who cannot join

  • Secondary malignancies
  • Previous allogeneic transplantation
  • Hematopoietic cell transplantation-specific comorbidity index > 4 (HCT-CI Sorror et al, Appendix M)
  • Known and manifested malignant involvement of the CNS
  • Active infectious disease
  • HIV- positivity or active hepatitis infection
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  • Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit)
  • Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
  • Pleural effusion or ascites > 1.0 L
  • Pregnancy or lactation
  • Known hypersensitivity to treosulfan and/or fludarabine
  • Participation in another experimental drug trial within 4 weeks before day -6
  • Non-co-operative behaviour or non-compliance
  • Psychiatric diseases or conditions that might impair the ability to give informed consent

Trial locations and contacts

12 sites in 1 country.

Luciano LC Callegaro, Monitor contact

+390226433903

callegaro.luciano@hsr.it

Stefania ST Trinca, Data Manager contact

+390226433903

trinca.stefania@hsr.it

12 sites in 1 country

Italy12 sites, 12 recruiting

  • USC Ematologia, Ospedali Riuniti

    Bergamo

    Anna Grassi, MD, agrassi@ospedaliriuniti.bergamo.it

    Maria Luisa Ferrari, DM, mlferrari@ospedaliriuniti.bergamo.it

    Recruiting

  • Ospedale centrale di Bolzano - Reparto di Ematologia

    Bolzano

    Enrico Morello, MD, +390471908807, enrico.morello@asbz.it

    Enrico Morello, MD

    Recruiting

  • PO "R.Binaghi" - CTMO

    Cagliari

    Adriana Vacca, MD, +393285452813, vaadriana@tiscali.it

    Giorgio La Nasa, MD

    Recruiting

  • AO "Santa Croce" e Carle - Reparto di Ematologia

    Cuneo

    Laura Bertolotti, Data Manager, +390171642229, laura.bertolotti@libero.it

    Andrea Gallamini, MD

    Recruiting

  • IRCCS San Raffaele; Unità Operativa di Ematologia

    Milan, MI, 20100

    Alessandro Crotta, MD, +39 0226433903, a.crotta@hsr.it

    Stefania Trinca, +39 0226434289, stefania.trinca@hsr.it

    Recruiting

  • Istituto Europeo di Oncologia - Divisione di Ematologia

    Milan

    Liliana Calabrese, Data Manager, +390257489536, liliana.calabrese@ieo.it

    Giovanni Martinelli, MD

    Recruiting

  • Ospedale Civile - UTI ematologia per il trapianto emopoietico

    Pescara

    Paolo Di Bartolomei, MD, pescaratmo@virgilio.it

    Paolo Di Bartolomei, MD

    Recruiting

  • Arcispedale Santa Maria Nuova - SC di Ematologia

    Reggio Emilia

    Alessandro Bonini, MD, bonini.alessandro@asmn.re.it

    Luigi Gugliotta, MD

    Recruiting

  • Dipartimento Biotecnologie Cellulari ed Ematologia; Azienda Policlinico Umberto I

    Roma, Roma, 00100

    Emilia Iannella, MD, +39 3202233365, emiliaiannella@libero.it

    Roberto Ricci, +39 3477578735, r.ricci@bce.uniroma1.it

    Recruiting

  • AO San Camillo Forlanini - UOC ematologia e trapianto

    Roma

    Beatrice Pinazzi, MD, mpinazzi@scamilloforlanini.rm.it

    Ignazio Majolino, MD

    Recruiting

  • Ematologia, Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia

    Angelo Michele Carella, MD, am.carella@operapadrepio.it

    Marzia Tricarico, DM, m.tricarico@operapadrepio.it

    Recruiting

  • AOU Santa Maria della Misericordia - Clinica Ematologica

    Udine

    Francesca Patriarca, MD, patriarca.francesca@aoud.sanita.fvg.it

    Michela Cerno, MD

    Recruiting

Other trials in Italy

About this study

Official title: Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Haematological Malignancies

This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies.

The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.

Being tested
Treosulfan IV
Medical subject headings
Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma

What participants receive

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

  • Treosulfan IVDrug

    Treosulfan i.v.: 14 g/m²/d from day -6 to day -4

Study groups in NCT00598624
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Treosulfan IV

What is being measured

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

  1. Efficacy: Evaluation of engraftment

    Measured: 28 days

  2. Safety: Evaluation of the incidence of CTC grade 3 and 4 adverse events

    Measured: between day -6 and day +28

Secondary outcomes (8)

  1. Efficacy: Evaluation of disease free survival (DFS)

    Measured: 1 year

  2. Efficacy: Evaluation of overall survival (OS)

    Measured: 1 year

  3. Efficacy: Evaluation of relapse incidence (RI)

    Measured: 1 year

  4. Efficacy: Documentation of donor chimerism

    Measured: on day +28, +56 and +100

  5. Safety: Evaluation of incidence of non-relapse mortality (NRM)

    Measured: on day +28 and day +100

  6. Safety: cumulative incidence of NRM

    Measured: 1 year

  7. Safety: Evaluation of cumulative incidence and severity of acute and chronic graft vs. host disease (GvHD)

    Measured: 1 year

  8. Safety: EBV reactivation

    Measured: 1 year

Timeline

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

  1. First posted22 Jan 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2010 (estimated)

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00598624
Sponsor's protocol ID
2005-005182-11
Other IDs
2005
Acronym
AlloTreo
Status last verified
Aug 2009
First submitted
10 Jan 2008
Last updated
11 Aug 2009
Results posted
No
Data monitoring committee
No

Publications

  • Lazzari L, Ruggeri A, Lupo Stanghellini MT, Mastaglio S, Messina C, Giglio F, Lorusso A, Perini T, Piemontese S, Marcatti M, Lorentino F, Xue E, Clerici D, Corti C, Bernardi M, Assanelli A, Greco R, Ciceri F, Peccatori J. Treosulfan-Based Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation: Long-Term Results From a Phase 2 Clinical Trial. Front Oncol. 2021 Sep 10;11:731478. doi: 10.3389/fonc.2021.731478. eCollection 2021.

    PubMed 34568066

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Treosulfan IV in people with Leukemia and Chronic Myeloid Leukemia, run by IRCCS San Raffaele at 12 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 30 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Luciano LC Callegaro, Monitor (+390226433903, callegaro.luciano@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Evaluation of engraftment (time frame: 28 days). The study lists 2 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 NCT00598624, which also lists 1 linked publication.

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 11 Aug 2009.

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