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Sponsors and Collaborators: |
Northern Italy Leukemia Group Associazione Italiana per la Ricerca sul Cancro (AIRC) |
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Information provided by: | Northern Italy Leukemia Group |
ClinicalTrials.gov Identifier: | NCT00358072 |
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.
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia |
Behavioral: Postremission consolidation based on MRD status |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Adult Acute Lymphoblastic Leukemia Using a Post-Remission Programme Whose Intensity Varies Depending on the Risk Class Defined on the Basis of Minimal Residual Disease. |
Estimated Enrollment: | 250 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | June 2006 |
Improved outcome of adult ALL through the application of:
Phase B therapy according to MRD results and ALL subset:
The illustrated strategy aims to optimize postremission consolidation therapy by offering standard treatment “only” to patients at lowest risk of relapse (MRD-), thereby reducing the risks of high dose treatments (expected TRM from allogeneic SCT 20-30%), while maintaining the latter approach in MRD+ cases and very HR subsets.
The prognostic role of MRD evaluation in unselected patients will be evaluated.
Ages Eligible for Study: | 15 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy, BG | |
Ospedali Riuniti di Bergamo | |
Bergamo, BG, Italy, 24128 | |
Italy, BS | |
Divisione Ematologia Spedali Civili | |
Brescia, BS, Italy, 25123 | |
Italy, BZ | |
Divisione di Ematologia e TMO Ospedale San Maurizio | |
Bolzano, BZ, Italy, 39100 | |
Italy, CA | |
U.O. Ematologia e Centro TMO Ospedale Armando Businco | |
Cagliari, CA, Italy, 09121 | |
Italy, CN | |
Ematologia Azienda Ospedaliera S.Croce e Carle | |
Cuneo, CN, Italy, 12100 | |
Italy, CR | |
U.S. Ematologia - Centro TMO Istituti Ospedalieri | |
Cremona, CR, Italy, 26100 | |
Italy, FI | |
Ematologia AOU Careggi | |
Firenze, FI, Italy, 50134 | |
Italy, MI | |
Ematologia Centro TMO Fondazione IRCSS Ospedale Maggiore | |
Milano, MI, Italy, 20122 | |
Ematologia e TMO Ospedale San Raffaele | |
Milano, MI, Italy, 20132 | |
Ematologia - TMO Ospedale San Gerardo | |
Monza, MI, Italy, 20052 | |
Italy, PA | |
Oncoematologia e TMO Dipartimento Oncologico | |
Palermo, PA, Italy, 90146 | |
Italy, to | |
Ematologia 2 Ospedale San Giovanni Battista | |
Torino, to, Italy, 10126 | |
Italy, VE | |
Divisione Ematologia Ospedale Umberto I | |
Mestre, VE, Italy, 30172 | |
Oncologia ed Ematologia Oncologica Institution Regione Veneto, ULSS n.13 - Presidi Ospedalieri di Noale, Mirano, Dolo | |
Noale, VE, Italy, 30033 | |
Italy, VI | |
Ematologia Ospedale San Bortolo | |
Vicenza, VI, Italy, 36100 |
Principal Investigator: | Bassan Renato, MD | Azienda Ospedaliera Ospedali Riuniti di Bergamo |
Study ID Numbers: | NILG-ALL 09/00, No |
Study First Received: | July 26, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00358072 |
Health Authority: | Italy: Ministry of Health |
Acute lymphoblastic leukemia Adult patients Minimal residual disease Risk-oriented therapy |
Neoplasm, Residual Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma Acute lymphoblastic leukemia, adult |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Immune System Diseases |