NCT00358072

Brief Summary

The study aims to optimize the concept of risk-oriented postremission consolidation therapy, by offering (i) standard consolidation-maintenance to patients at lowest risk of relapse as defined by MRD(Minimal Residual Disease) negative status, and (ii) allogeneic stem cell transplantation (related/unrelated donor available) or multicycle high-dose therapy with autologous blood stem cell transplant (no donor) to patients at highest risk of relapse as defined by MRD+ status. The prognostic role of MRD evaluation in unselected patients will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2000

Longer than P75 for phase_2

Geographic Reach
1 country

15 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

May 1, 2000

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 29, 2010

Status Verified

December 1, 2010

Enrollment Period

6.6 years

First QC Date

July 26, 2006

Last Update Submit

December 28, 2010

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute lymphoblastic leukemiaAdult patientsMinimal residual diseaseRisk-oriented therapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival at 5 years

    5 year from date of complete remission

Secondary Outcomes (5)

  • Complete remission

    4 or 8 weeks from date of therapy start

  • Overall survival

    5 years from date of diagnosis

  • Cumulative incidence of relpase

    5 years from date of complete remission

  • Remissional deaths

    4 weeks from date of therapy start

  • Nonlethal toxicity

    5 years from date of therapy start

Study Arms (1)

1

EXPERIMENTAL

Application of combination chemotherapy aimed to reduce MRD burden in unselected patients, followed by MRD-adjusted therapy that range from maintenance chemotherapy (MRD-negative patients) to allogeneic SCT (MRD-positive patients) or high-dose therapy with autologous blood stem cell support (MRD-positive patients without compatible donor for allogeneic SCT)

Behavioral: Postremission consolidation based on MRD status

Interventions

Postremission consolidation based on MRD statusBEHAVIORAL

Application of combination chemotherapy aimed to reduce MRD burden in unselected patients, followed by MRD-adjusted therapy that range from maintenance chemotherapy (MRD-negative patients) to allogeneic SCT (MRD-positive patients) or high-dose therapy with autologous blood stem cell support (MRD-positive patients without compatible donor for allogeneic SCT)

Also known as: MRD-guided therapy
1

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Untreated Acute lymphoblastic leukemia or lymphoblastic lymphoma (T-cell, precursor B-cell)
  • Age 15-65 years (older patients if biologically fit according to responsible physician)
  • Written informed consent

You may not qualify if:

  • Any co-morbidity precluding the administration of intensive chemotherapy for adult ALL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Ospedali Riuniti di Bergamo

Bergamo, BG, 24128, Italy

Location

Divisione Ematologia Spedali Civili

Brescia, BS, 25123, Italy

Location

Divisione di Ematologia e TMO Ospedale San Maurizio

Bolzano, BZ, 39100, Italy

Location

U.O. Ematologia e Centro TMO Ospedale Armando Businco

Cagliari, CA, 09121, Italy

Location

Ematologia Azienda Ospedaliera S.Croce e Carle

Cuneo, CN, 12100, Italy

Location

U.S. Ematologia - Centro TMO Istituti Ospedalieri

Cremona, CR, 26100, Italy

Location

Ematologia AOU Careggi

Florence, FI, 50134, Italy

Location

Ematologia Centro TMO Fondazione IRCSS Ospedale Maggiore

Milan, MI, 20122, Italy

Location

Ematologia e TMO Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Ematologia - TMO Ospedale San Gerardo

Monza, MI, 20052, Italy

Location

Oncoematologia e TMO Dipartimento Oncologico

Palermo, PA, 90146, Italy

Location

Ematologia 2 Ospedale San Giovanni Battista

Torino, TO, 10126, Italy

Location

Divisione Ematologia Ospedale Umberto I

Mestre, VE, 30172, Italy

Location

Oncologia ed Ematologia Oncologica Institution Regione Veneto, ULSS n.13 - Presidi Ospedalieri di Noale, Mirano, Dolo

Noale, VE, 30033, Italy

Location

Ematologia Ospedale San Bortolo

Vicenza, VI, 36100, Italy

Location

Related Publications (4)

  • Bassan R, Spinelli O, Oldani e et al. Minimal residual disease (MRD) and risk-oriented therapy in adult acute lymhoblastic leukemia (ALL). Blood (ASH Annual Meeting Abstract) 106: abstract 1836, 2005.

    RESULT

  • Bassan R, Spinelli O, Oldani E, Intermesoli T, Tosi M, Peruta B, Rossi G, Borlenghi E, Pogliani EM, Terruzzi E, Fabris P, Cassibba V, Lambertenghi-Deliliers G, Cortelezzi A, Bosi A, Gianfaldoni G, Ciceri F, Bernardi M, Gallamini A, Mattei D, Di Bona E, Romani C, Scattolin AM, Barbui T, Rambaldi A. Improved risk classification for risk-specific therapy based on the molecular study of minimal residual disease (MRD) in adult acute lymphoblastic leukemia (ALL). Blood. 2009 Apr 30;113(18):4153-62. doi: 10.1182/blood-2008-11-185132. Epub 2009 Jan 13.

    PMID: 19141862RESULT

  • Bassan R, Rossi G, Pogliani EM, Di Bona E, Angelucci E, Cavattoni I, Lambertenghi-Deliliers G, Mannelli F, Levis A, Ciceri F, Mattei D, Borlenghi E, Terruzzi E, Borghero C, Romani C, Spinelli O, Tosi M, Oldani E, Intermesoli T, Rambaldi A. Chemotherapy-phased imatinib pulses improve long-term outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: Northern Italy Leukemia Group protocol 09/00. J Clin Oncol. 2010 Aug 1;28(22):3644-52. doi: 10.1200/JCO.2010.28.1287. Epub 2010 Jul 6.

    PMID: 20606084RESULT

  • Mannelli F, Gianfaldoni G, Intermesoli T, Cattaneo C, Borlenghi E, Cortelazzo S, Cavattoni I, Pogliani EM, Fumagalli M, Angelucci E, Romani C, Ciceri F, Corti C, Scattolin A, Cortelezzi A, Mattei D, Audisio E, Spinelli O, Oldani E, Bosi A, Rambaldi A, Bassan R. CD20 expression has no prognostic role in Philadelphia-negative B-precursor acute lymphoblastic leukemia: new insights from the molecular study of minimal residual disease. Haematologica. 2012 Apr;97(4):568-71. doi: 10.3324/haematol.2011.054064. Epub 2011 Nov 4.

    PMID: 22058217DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bassan Renato, MD

    Azienda Ospedaliera Ospedali Riuniti di Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 28, 2006

Study Start

May 1, 2000

Primary Completion

December 1, 2006

Study Completion

September 1, 2008

Last Updated

December 29, 2010

Record last verified: 2010-12

Locations

IT(15)