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GMALL 2002 overview (patients under 55 years)

Patients with lymphoma should be considered for inclusion into clinical trials. Link to ALLG website opens in a new tab or window, ANZCTR website opens in a new tab or window and Lymphoma Australia website. opens in a new tab or window

This protocol is based on limited evidence; refer to the evidence section of this protocol for more information.

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GMALL 2002 pre phase (patients under 55)

Duration:
5 days
Cycles:
1. Pre-phase is given prior to Block A1. After a break on day 6, patients will proceed to treatment with Block A1.

Patient information

The number of cycles of Blocks A, B and C are dependent on the stage of disease:

Stage I/II disease Total of 4 cycles (A1-B1-C1-A2) followed by two additional doses of rituximab every 21 days after completion of A2.r
Stage III/IV disease or mediastinal and extra-nodal involvement Total of 6 cycles (A1-B1-C1-A2-B2-C2) followed by two additional doses of rituximab every 21 days after completion of C2.r

Radiation therapy may also be given to selected patients (see evidence section) 

GMALL 2002 block A (patients under 55)

Frequency:
21 days
Cycles:
2

Patient information

GMALL 2002 block B (patients under 55)

Duration:
21 days
Cycles:
1 to 2 depending on stage of disease

Patient information

GMALL 2002 block C (patients under 55)

Duration:
21 days
Cycles:
1 to 2 depending on stage of disease

Patient information
  • Burkitt lymphoma and/or mature B-cell acute lymphoblastic leukaemia in patients 18 to 55 years of age

This GMALL B-ALL/NHL 2002 protocol was developed for treatment of mature B-ALL and Burkitt lymphoma and evolved from 3 preceding protocols: B-NHL83, B-NHL86 and B-NHL90.r The GMALL study group developed these protocols based on concepts employed successfully in the treatment of paediatric mature B-ALL. All used short, alternating cycles of intensive chemotherapy (in an ABABAB pattern) that included high doses of methotrexate and cyclophosphamide. The B-NHL90 protocol incorporated an increase in methotrexate doses to 3 g/m2 but this did not result in improvement in outcomes when compared with B-NHL86.r

GMALL B-ALL/NHL 2002 differs from the preceding protocols in the addition of 8 doses of rituximab and of cycle C, incorporating high dose cytarabine and methotrexate for patients ≤55 years (changing the schedule to ABCABC).rr The methotrexate dose is reduced back to 1.5 g/m2. In patients over 55 years, no high dose cytarabine is given and the methotrexate dose is 500 mg/m2 (schedule ABABAB;).r In all patients with stage I/II disease and CR after 2 cycles, treatment is abbreviated to 4 cycles.r In addition to the chemo-immunotherapy, the GMALL group recommend radiation therapy to the CNS (24Gy; for CNS involvement) and to large mediastinal tumours (36Gy; >7.5 cm mass).r

Source Study & Year Published Supports Use Is the dose and regimen consistent with the protocol? Comments
Phase II trials Oriol et al. 2008r Yes Yes  
Prospective study Intermesoli et al. 2013r Yes Yes  
Hoelzer et al. 2014r Yes Yes  
Observational studies N/A N/A N/A  
Guidelines Date published/revised Supports Use Is the dose and regimen consistent with the protocol? Comments
NCCN N/A N/A N/A  
BCCA N/A N/A N/A  
CCO N/A N/A N/A  

Efficacy

The outcomes of 363 patients with Burkitt Lymphoma and Burkitt’s Leukaemia (mature B cell or L3-ALL) treated with the GMALL B-ALL/NHL 2002 protocol were reported in 2014.r The complete remission (CR) rate was 88% with 5 year progression free survival (PFS) 75% and overall survival (OS) 80%. There were significant differences in CR, PFS and OS between the ≤55 years and >55 years groups (see table).

© Blood 2014

Multivariate analysis revealed the following factors predicted overall survival in this group of patients: age (≤55 vs >55 years), bone marrow involvement, LDH, and gender.r

The GMALL B-ALL/NHL 2002 protocol has been trialled by other groups. The Northern Italy Leukemia Group (NILG) treated 105 patients with Burkitt lymphoma and leukaemia (mature B-ALL, 48%) with GMALL B-ALL/NHL 2002.r Twenty-five percent of their cohort were over 55 years old, 14% were HIV positive and 37% had an ECOG >1.r The CR rate was 79%, 3 year OS 67% and disease free survival (DFS) 75%. Outcomes were better in the younger group (≤60 years), with OS 75% and DFS 82%. On multivariate analysis, the two significant indicators of prognosis were age (≤60 vs >60 years) and performance status (0-1 vs >1).r

Oriol et al also reported CR rates of 84 to 88% in 36 patients with Burkitt’s lymphoma/leukaemia treated with the GMALL regimen. Nineteen (56%) of the patients were HIV positive and there were no significant differences in response rates or 2 year survival in the HIV positive, compared with negative, patients.r

Toxicity

The GMALL group listed the major grade 3 and 4 toxicities of the GMALL B-ALL/NHL 2002 protocol as haematological, especially grade 3-4 neutropenia during cycle A1, and infections (occurring in 38% of patients in cycle A1). Liver toxicity was most common during the first cycle and grade 3/4 mucositis was common during the first 2 cycles.r Therapy related deaths occurred in 2% of the ≤55 years patients but 11% of the >55 group, with >90% of deaths caused by infection.r

The NILG reported treatment related mortality in 14 (of 105) patients during induction (79% due to infection) and 5 patients during consolidation therapy. Severe neutropenia (<0.5x10^9/L) was present for a median of 7 days (0-25) in ≤55 year olds and 8 days (0-23) in the older patients. Thrombocytopenia (<20x10^9/L) was present for a median of 3(0-45) and 5(0-32) days respectively.r The rate of infection was 48%. Chemotherapy-induced mucositis and severe infections were more common in HIV positive patients compared with HIV negative.r

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Version 4

Date Summary of changes
23/08/2021 New block A protocol (ID 3804) developed to replace teniposide with etoposide. This protocol replaces protocol ID 1651. Protocol approved and published on eviQ. Review in 1 year.
27/05/2022 Protocol title updated to reflect eviQ naming convention.
11/11/2022 Reviewed electronically the by Haematology Reference Committee, rituximab PBS status changed to general. Minor formatting changes. Review in 2 years.

Version 3

Date Summary of changes
08/11/2016 Approved and published on eviQ.
31/05/2017 Transferred to new eviQ website. Version number change to V.2.
21/09/2018 Reviewed by Haematology Reference Committee with no significant changes, review in 1 year. Version number changed to V.3.
13/09/2019 Reviewed by Haematology Reference Committee, no changes made. Review in 5 years. 

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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https://www.eviq.org.au/p/1894

02 Apr 2025