ALLG NHL26 A Phase 2 Study of patients treated for relapsed Follicular Lymphoma: with Revlimid (Registered Trademark) consolidation added to Rituximab maintenance therapy in those remaining Positron Emission Tomography (PET) positive

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

"Dataset includes: - data for 37 patients with relapsed follicular lymphoma - PET response of all 37 registered patients at screening, 6 months post study treatment, and at disease progression - QoL data for all patients up to 18 months of follow-up - 2 years of Rituximab and Lenolidomide treatment data - Follow-up treatment data for all patients up to 18months - Comparison of treatment arm data for conversion of PET+ to PET - Progression Free Survival and Overall survival data "
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Chemotherapy |

Source Study


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

A/Prof Judith Trotman

Brief Summary

The prognosis for patients with FL has significantly improved during the last decade with the incorporation of Rituximab into therapy. Rituximab maintenance has become a standard of care after initial rituximab-chemotherapy for remission induction. Lenalidomide is an immune system modulating drug that has anti-lymphoma properties demonstrated in smaller studies of patients with relapsed/refractory Diffuse large B-cell lymphoma. Lenalidomide consolidation added to Rituximab maintenance therapy ma ....
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Key Inclusion Criteria

Relapsed follicular lymphoma having obtained conventional Stable disease (SD), Partial Response (PR), Complete remission unconfirmed (CRu) or Complete Remission (CR) after most recent reinduction therapy. Response assessment within 4-6 weeks of day 1 of last chemotherapy cycle. Relapsed disease must be either Stage III or IV, or Stage II bulky disease defined as a tumor diameter of greater than or equal to 7 cm. Symptomatic disease in need of systemic immunochemotherapy treatment as defined by t ....
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Key Exclusion Criteria

Patients with demonstrated histological transformation Patients who have: >6 prior cycles of Fludarabine Allogeneic transplant Prior exposure to Lenalidomide Patients who have had a negative PET scan during re-induction therapy Patients with poor haemopoeitic recovery 4-8 weeks post chemotherapy Patients with inadequate liver function Patients with severe renal impairment Medial contraindication to rituximab CNS involvement with lymphoma Any uncontrolled inter-current illness HIV, Hepatitis B or ....
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Can healthy volunteers participate?




Sample Size    37

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Relapsed Follicular Lymphoma

Condition code    Cancer


Intervention code Treatment: Drugs , Treatment: Other

Patients will undergo a Positron Emission Tomography (PET) scan and then be assigned to the PET+ or PET- arm of the study. PET scan preparation and procedure will take approximately 2 hours. Patients will also be required to fast for four hours prior to the scan. Diabetic patients should discuss fasting requirements with their doctor. Plain, unflavoured water may be consumed while fasting. Postinducton PET- patients: Rituximab 375mg/m2 by i.v or 1400mg s.c every 3 months for 2 years. Postinducto ....
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Control group Active

Postinducton PET- patients: Rituximab 375mg/m2 by i.v or 1400mg s.c every 3 months for 2 years


Outcome: To determine the percentage of patients converting from PET+ after reinduction immunochemotherapy to PET- after 6 months of commencing Lenalidomide consolidation. PET+ will be defined as cut-off =3 using 5 point scale (5PS), and determined by a consensus response interpretation by local and central PET physician.
Timepoint: After 6 months of Lenalidomide treatment

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see