Data

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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Subjects

Chemotherapy |

Related Study

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 (ALLG NHL26)

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 may convert PET+ patients to PET-, without causing unmanageable side effects. Positron emission tomography (PET) is a medical imaging tool that can detect cancer in its early stages, help to monitor cancer treatment and check if the cancer is coming back. Lay Summary: Follicular lymphoma is the most common type of slow growing non Hodgkin lymphoma. Treatments and outcomes have improved considerably in the last 10 years with the introduction of the drug, rituximab to standard chemotherapy treatments. However, the disease returns repeatedly in many patients. PET scanning is a type of test used by doctors to outline where the lymphoma is in the body. PET scans will ‘light up’ the areas of active follicular lymphoma. Such positive PET scans after the end of treatment indicate that it is likely the lymphoma will return soon. This study is for patients with returned disease who have already received treatment again and so are at even higher risk of disease returning yet again. Patients will receive rituximab and up to 24 months of another drug, lenalidomide, which is designed to help the body’s own immune system to keep the lymphoma away. The study will decide if the extra treatment with lenalidomide can change the scan result to negative and improve patient outcomes.

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 the investigator. Patient has provided written informed consent Life expectancy at least 6 months An Eastern Co-operative Oncology Group (ECOG) performance status score of less than or equal to 2 at Screening

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

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

yes

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