A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: Final results of the GIMEMA LAL 0904 study

Chiaretti, S.; Vitale, A.; Vignetti, M.; Piciocchi, A.; Fazi, P.; Elia, L.; Falini, B.; Ronco, F.; Ferrara, F.; De Fabritiis, P.; Luppi, M.; La Nasa, G.; Tedeschi, A.; Califano, C.; Fanin, R.; Dore, F.; Mandelli, F.; Meloni, G.; Foa, R.

doi:10.3324/haematol.2016.144535

Cited by 98Acute Lymphoblastic Leukemia researchChronic Myeloid Leukemia TreatmentsChronic Lymphocytic Leukemia Research

A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: Final results of the GIMEMA LAL 0904 study

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Chiaretti, S., Vitale, A., Vignetti, M., Piciocchi, A., Fazi, P., Elia, L., Falini, B., Ronco, F. +11 more·2016·Haematologica

DOI 10.3324/haematol.2016.144535PMC PMC5479612

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Abstract

In the GIMEMA LAL 0904 protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant. Fifty-one patients (median age 45.9 years) were enrolled in the final sequential protocol. At the end of induction (day +50), 96% of evaluable patients (n=49) achieved a complete hematologic remission; after consolidation, all were in complete hematologic remission. No deaths in induction were recorded. Overall survival and disease-free survival at 60 months are 48.8% and 45.8%, respectively. At day +50 (end of imatinib induction), a more than 1.3 log-reduction of BCR-ABL1 levels was associated with a significantly longer disease-free survival (55.6%, 95%CI: 39.0–79.3 vs. 20%, 95%CI: 5.8–69.1; P=0.03), overall survival (59.1%, 95%CI: 42.3–82.6 vs. 20%, 95%CI: 5.8–69.1; P=0.02) and lower incidence of relapse (20.5%, 95%CI: 7.2–38.6 vs. 60.0%, 95%CI: 21.6–84.3; P=0.01). Mean BCR-ABL1 levels remained significantly higher in patients who subsequently relapsed. Finally, BCR-ABL1p190 patients showed a significantly faster molecular response than BCR-ABL1p210 patients (P=0.023). Though the study was not powered to evaluate the role of allogeneic stem cell transplant, allografting positively impacted on both overall and disease-free survival. In conclusion, a sequential approach with imatinib alone in induction, consolidated by chemotherapy plus imatinib followed by a stem cell transplant is a feasible, well-tolerated and effective strategy for adult Philadelphia positive acute lymphoblastic leukemia, leading to the best long-term survival rates so far reported. (clinicaltrials.gov identifier: 00458848).

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TrkB agonism or positive modulation with 7,8-DHF restores thin spine maturity, prevents stress- or age-related synaptic erosion, and sustains cognitive recovery across hippocampal, amygdalar, and cortical circuits.
“TrkB agonism or positive modulation with 7,8-DHF restores thin spine maturity, prevents stress- or age-related synaptic erosion, and sustains cognitive recovery across hippocampal, amygdalar, and cortical circuits [343,344].”
From Synaptic Plasticity—Intrinsic Excitability and Antidepressant Discovery (2026) · cites this paper as [344]
The Introduction and Relapses sections discuss treatment and outcomes in Philadelphia chromosome–positive acute lymphoblastic leukemia, not synaptic structure or cognition; page numbers are unavailable in our copy. Searches for 7,8-DHF, TrkB, spine maturity, synaptic erosion, and cognitive recovery found no passage addressing the claim. (LLM, conf=0.78)
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Authors: Chiaretti, S., Vitale, A., Vignetti, M., Piciocchi, A., Fazi, P., Elia, L., Falini, B., Ronco, F., Ferrara, F., De Fabritiis, P., Luppi, M., La Nasa, G., Tedeschi, A., Califano, C., Fanin, R., Dore, F., Mandelli, F., Meloni, G., & Foa, R.
Affiliations: Sapienza University of Rome (IT)
Fondazione Gimema Onlus (IT)
University of Perugia (IT)
Azienda ospedaliera "Bianchi-Melacrino-Morelli" (IT)
Ospedale Antonio Cardarelli (IT)
University of Modena and Reggio Emilia (IT)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
Azienda Sanitaria Locale Salerno (IT)
University of Udine (IT)
ORCID: Chiaretti, S.
Vignetti, M.
Piciocchi, A.
Fazi, P.
Falini, B.
Ronco, F.
Luppi, M.
Venue: Haematologica
Publisher: Ferrata Storti Foundation (Haematologica)
Published: 2016-08-11
Volume: 101
Issue: 12
Pages: 1544-1552
ISSN: 0390-6078 (ISSN-L)
1592-8721
DOI: 10.3324/haematol.2016.144535
PMC: PMC5479612
OpenAlex: W2509076190
Cited by: 98
References: 57
Citations by year: 2026: 10 · 2025: 11 · 2024: 7 · 2023: 8 · 2022: 11 · 2021: 15 · 2020: 11 · 2019: 7 · 2018: 11 · 2017: 5 · 2016: 2
FWCI: 8.26
Type: journal article
Language: en
Open access: gold
doi.org
Locations: Haematologica (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Institutional Research Information System (University of Udine) (submittedVersion, cc-by-nc-nd)
Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
UNICA IRIS Institutional Research Information System (University of Cagliari) (submittedVersion, other-oa)
Funders: Ministero dell’Istruzione, dell’Università e della Ricerca (5x1000)
Sapienza Università di Roma
Associazione Italiana per la Ricerca sul Cancro (5X 1000)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Acute Lymphoblastic Leukemia research
Health Sciences › Medicine › Hematology › Chronic Myeloid Leukemia Treatments
Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
Keywords: Philadelphia chromosome-positive acute lymphoblastic leukemia, adult acute lymphoblastic leukemia, imatinib, sequential therapy, induction chemotherapy, consolidation chemotherapy, maintenance therapy, allogeneic stem cell transplantation, molecular response, relapse, overall survival, disease-free survival
MeSH terms: Imatinib Mesylate, Adolescent, Adult, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Combined Modality Therapy, Female, Humans, Male, Middle Aged, Recurrence, Remission Induction, Survival Analysis, Fusion Proteins, bcr-abl, Treatment Outcome, Neoplasm, Residual, Hematopoietic Stem Cell Transplantation, Retreatment, Protein Kinase Inhibitors, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Young Adult

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A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: Final results of the GIMEMA LAL 0904 study

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