⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Treatment of Adult ALL With an MRD-directed Programme.

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Treatment of Adult ALL With an MRD-directed Programme.

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.

Study ID: NCT00358072

Study Description

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.

Detailed Description: Improved outcome of adult ALL through the application of: * Risk-adapted induction (cycle no. 1: IVAP i.e idarubicin-vincristine-asparaginase-prednisone, plus fractionated cyclophosphamide in T-ALL,and imatinib in Ph/BCR-ABL+ ALL) * Risk stratification (clinical) according to morphology, immunophenotype, cytogentics and molecular biology results. Standard risk (SR) is defined by pre-B CD10+ phenotype, Ph/BCR-ABL- status, and a blast count \<10x10e9/L. All other subgroups are HR (high-risk) except for Ph/BCR-ABL+ and t(4;11)+ ALL (VHR, very high-risk) * Homogeneous early consolidation programme including both conventional therapy with idarubicin-vincristine-cyclophosphamide-dexamethasone/prednisone(cycles no. 2,3,5,6,8) and high-dose treatemt with MTX/Ara-C (cycles no. 4,7) and meningeal prophylaxis (triple intrathecal therapy x8-12, skull irradiation), plus imatinib in Ph+ ALL (Phase A). Autologous bllo stem cells are mobilized and cryopreserved after cycle no. 4. * Serial evaluation of minimal residual disease (MRD) with RQ-PCT technology, aiming to define in individual patients the rate of reduction during early consolidation. The molecular study was centralized and aimed at obtaining one or more patient-specific probe(s)with a sensitivity of at least 10e-3. Patient bone marrow was sampled for MRD analysis at timepoints 13 i.e. after cycles no.3,5, and 7. Only patients with a negative result at timepoint 3 and a negative/low positive (\<10e-4) result at timepoint 3 are considered MRD-, all other combinations being regarded MRD+. * Phase B therapy according to MRD results and ALL subset: * MRD- nonPh/t(4;11): standard maintenance * MRD+ nonPh/t(4;11): allogeneic stem cell transplantation (from sibling/MUD) or, alternatively, intensified high-dose therapy (2-4 "hypercycles")with autologous stem cell support and anti CD20 MoAb (if CD20+), followed by maintenance. Each "hypercycle" consists of high-dose mercaptopurine-etoposide-melphalan (cycles no. 1,3) or methotrexate-cytarabine (cycles no. 2,4) * MRD unknown nonPh/t(4;11): treatment by clinical risk (SR: maintenance; HR, as per MRD+) * Ph/t(4;11)+: allogeneic stem cell transplantation as soon as possible into complete remission; if a transplant is not possible, consolidation is as for HR patients. each cycle is supplemented by imatinib in Ph+ ALL 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.

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ospedali Riuniti di Bergamo, Bergamo, BG, Italy

Divisione Ematologia Spedali Civili, Brescia, BS, Italy

Divisione di Ematologia e TMO Ospedale San Maurizio, Bolzano, BZ, Italy

U.O. Ematologia e Centro TMO Ospedale Armando Businco, Cagliari, CA, Italy

Ematologia Azienda Ospedaliera S.Croce e Carle, Cuneo, CN, Italy

U.S. Ematologia - Centro TMO Istituti Ospedalieri, Cremona, CR, Italy

Ematologia AOU Careggi, Firenze, FI, Italy

Ematologia Centro TMO Fondazione IRCSS Ospedale Maggiore, Milano, MI, Italy

Ematologia e TMO Ospedale San Raffaele, Milano, MI, Italy

Ematologia - TMO Ospedale San Gerardo, Monza, MI, Italy

Oncoematologia e TMO Dipartimento Oncologico, Palermo, PA, Italy

Ematologia 2 Ospedale San Giovanni Battista, Torino, TO, Italy

Divisione Ematologia Ospedale Umberto I, Mestre, VE, Italy

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

Ematologia Ospedale San Bortolo, Vicenza, VI, Italy

Contact Details

Name: Bassan Renato, MD

Affiliation: Azienda Ospedaliera Ospedali Riuniti di Bergamo

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: