The GMALL B ALL/NHL 2002 protocol yields high rates of durable response in high grade B cell lymphoma - Report - MDSpire
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GMALL B-ALL/NHL 2002 Protocol Achieves High Rates of Sustained Response in High-Grade B-Cell Lymphoma

  • By

  • Silvia Ferrari

  • Francesco Ballardini

  • Andrea Rossi

  • Anna Grassi

  • Chiara Pavoni

  • Monica Rondi

  • Paolo Fruscella

  • Andrea Gianatti

  • Giuseppe Gritti

  • Anna Maria Barbui

  • Federico Lussana

  • Alessandro Rambaldi

  • October 9, 2026

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Clinical Report: GMALL B-ALL/NHL 2002 in High-Grade B-Cell Lymphoma

Overview

In this single-institution cohort of 53 patients with high-grade B-cell lymphoma (HGBCL), treatment with the GMALL B-ALL/NHL 2002 protocol was associated with an end-of-treatment metabolic complete response in 42 patients (79.2%) and an overall 6-year progression-free survival (PFS) of 72%. Six-year PFS differed by histology, at 83% for HGBCL-NOS and 49% for double-hit lymphoma (DHL). The report also describes early CNS relapses among three patients who had achieved complete response.

Background

The source describes front-line HGBCL management as challenging because no consensus standard of care has been established. Prospective studies have often grouped HGBCL with diffuse large B-cell lymphoma (DLBCL), leaving clinical recommendations dependent on subset analyses and extrapolation. Intensified regimens such as CODOX-M-IVAC and R-DA-EPOCH are used, but comparisons are limited by differing eligibility criteria and small study populations. The report notes that fluorescence in situ hybridization (FISH) for MYC, BCL2, and BCL6 rearrangements was used to characterize patients in its cohort.

Data Highlights

MeasureFinding
Patients treated53
HistologyHGBCL-NOS: 34 (64.1%); DHL: 19 (35.9%)
Median age56 years (range, 21–75); 27 patients (50.9%) were older than 55 years
End-of-treatment responseMetabolic complete response: 42 (79.2%); partial response: 7 (13.2%); no clinically meaningful response: 4
Six-year PFSOverall: 72%; HGBCL-NOS: 83%; DHL: 49%
Six-year PFS by ageOlder than 55 years: 61%; younger than 55 years: 82%
Three-year PFS in patients older than 55 yearsFull-course therapy: 88%; age-reduced schedule: 68%
Follow-up and survivalMedian follow-up: 4.5 years (range, 0.4–13); 42 patients (75%) remained alive
Treatment deliveryFull-intensity regimen: 36 patients, including 10 older than 55 years; protocol-based age-reduced schedule: 17 patients. Toxicity required dose-intensity reduction in 5 (9.4%)
Median intercycle timeOverall: 29 days (range, 21–60); no reported difference by histology (p = 0.42) or age (p = 0.65)

Key Findings

  • The cohort comprised 34 patients with HGBCL-NOS and 19 with DHL, classified according to WHO 2022; median age was 56 years.
  • At end of treatment, 42 patients (79.2%) achieved metabolic complete response and 7 (13.2%) achieved partial response; four had no clinically meaningful response.
  • Overall 6-year PFS was 72%, with reported rates of 83% for HGBCL-NOS and 49% for DHL.
  • Six-year PFS was 61% among patients older than 55 years and 82% among those younger than 55 years. Within the older subgroup, reported 3-year PFS was 88% with full-course therapy and 68% with the dose-reduced schedule.
  • Three patients who achieved complete response developed CNS relapse within 3 months; all three rapidly progressed and died despite subsequent treatment described in the report.
  • After a median follow-up of 4.5 years, 42 patients (75%) were alive. Eleven deaths were reported: nine from refractory or relapsed disease and two during complete response; one death followed therapy-related myelodysplastic syndrome.

Conclusion

In this cohort, the GMALL B-ALL/NHL 2002 protocol was associated with a 79.2% end-of-treatment metabolic complete response rate and 72% overall 6-year PFS. Outcomes varied by histology, and early CNS relapse occurred in three patients who had achieved complete response.

Related Resources & Content

  1. Authors not specified in supplied text, Blood Cancer Journal, 2026 — The GMALL B ALL/NHL 2002 protocol yields high rates of durable response in high grade B cell lymphoma
  2. The ASCO Post, 2018 — Responses Reported With CAR T-Cell Therapy in High-Risk NHL
  3. Casasnovas R-O, Ysebaert L, et al., ASCO Publications, 2014 — Final results of a randomized phase II GELA/LYSA study of rituximab plus ACVBP or CHOP, using a PET-driven consolidation strategy, in patients with high-risk diffuse large B-cell lymphoma (DLBCL)
  4. The ASCO Post, 2013 — Sustained Complete Responses With Novel Immunotherapy in Lymphoma Key Points
  5. Authors not specified in supplied text, ScienceDirect — High-grade B-cell lymphomas: Double hit and non-double hit
  6. ASCO Publications — Durable complete response and overall survival in patients with heavily pretreated, poor-prognosis non-Hodgkin lymphoma to immunoactivating AVM0703 with few and mild drug-related adverse effects.
  7. The GMALL B ALL/NHL 2002 protocol yields high rates of durable response in high grade B cell lymphoma
  8. High-grade B-cell lymphomas: Double hit and non-double hit
  9. Responses Reported With CAR T-Cell Therapy in High-Risk NHL
  10. High-grade B-cell lymphomas: Double hit and non-double hit - ScienceDirect
  11. Population-wide introduction of dose-adjusted EPOCH-R in high-grade B-cell lymphoma with MYC/BCL2 rearrangements, DLBCL morphology - PubMed

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