--- title: Treatment of Adult ALL With an MRD-directed Programme. nct_id: NCT00358072 overall_status: COMPLETED phase: PHASE2 sponsor: Northern Italy Leukemia Group study_type: INTERVENTIONAL primary_condition: Acute Lymphoblastic Leukemia countries: Italy canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00358072.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00358072" ct_last_update_post_date: 2010-12-29 last_seen_at: "2026-05-12T07:13:00.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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. **NCT ID:** [NCT00358072](https://clinicaltrials.gov/study/NCT00358072) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 280 - **Lead Sponsor:** Northern Italy Leukemia Group - **Collaborators:** Associazione Italiana per la Ricerca sul Cancro - **Conditions:** Acute Lymphoblastic Leukemia - **Start Date:** 2000-05 - **Completion Date:** 2008-09 - **CT.gov Last Update:** 2010-12-29 ## 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 - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 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 Exclusion Criteria: * Any co-morbidity precluding the administration of intensive chemotherapy for adult ALL ``` ## Arms - **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) ## Interventions - **Postremission consolidation based on MRD status** (BEHAVIORAL) — 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) ## Primary Outcomes - **Disease-free survival at 5 years** _(time frame: 5 year from date of complete remission)_ ## Secondary Outcomes - **Complete remission** _(time frame: 4 or 8 weeks from date of therapy start)_ - **Overall survival** _(time frame: 5 years from date of diagnosis)_ - **Cumulative incidence of relpase** _(time frame: 5 years from date of complete remission)_ - **Remissional deaths** _(time frame: 4 weeks from date of therapy start)_ - **Nonlethal toxicity** _(time frame: 5 years from date of therapy start)_ ## Locations (15) - 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, Florence, FI, Italy - Ematologia Centro TMO Fondazione IRCSS Ospedale Maggiore, Milan, MI, Italy - Ematologia e TMO Ospedale San Raffaele, Milan, 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 ## Recent Field Changes (last 30 days) - `locations.divisione ematologia spedali civili|brescia|bs|italy` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.ospedali riuniti di bergamo|bergamo|bg|italy` — added _(2026-05-12)_ - `locations.divisione di ematologia e tmo ospedale san maurizio|bolzano|bz|italy` — added _(2026-05-12)_ - `locations.u.o. ematologia e centro tmo ospedale armando businco|cagliari|ca|italy` — added _(2026-05-12)_ - `locations.ematologia azienda ospedaliera s.croce e carle|cuneo|cn|italy` — added _(2026-05-12)_ - `locations.u.s. ematologia - centro tmo istituti ospedalieri|cremona|cr|italy` — added _(2026-05-12)_ - `locations.ematologia aou careggi|florence|fi|italy` — added _(2026-05-12)_ - `locations.ematologia centro tmo fondazione ircss ospedale maggiore|milan|mi|italy` — added _(2026-05-12)_ - `locations.ematologia e tmo ospedale san raffaele|milan|mi|italy` — added _(2026-05-12)_ - `locations.ematologia - tmo ospedale san gerardo|monza|mi|italy` — added _(2026-05-12)_ - `locations.oncoematologia e tmo dipartimento oncologico|palermo|pa|italy` — added _(2026-05-12)_ - `locations.ematologia 2 ospedale san giovanni battista|torino|to|italy` — added _(2026-05-12)_ - `locations.divisione ematologia ospedale umberto i|mestre|ve|italy` — added _(2026-05-12)_ - `locations.oncologia ed ematologia oncologica institution regione veneto, ulss n.13 - presidi ospedalieri di noale, mirano, dolo|noale|ve|italy` — added _(2026-05-12)_ - `locations.ematologia ospedale san bortolo|vicenza|vi|italy` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00358072.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00358072* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*