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RecruitingLast updated: 23 January 2024

RePLY: This phase II trial is evaluating the combination of revlimid (chemotherapy) and rituximab maintenance therapy in the treatment of patients with Follicular LymphomaALLG 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

Clinical 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.


This trial is treating patients with Follicular Lymphoma


Blood Cancers Haematological





Trial Acronym


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Trial Identifiers

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Trial sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

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




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


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 Hepatitis C infection

Pregnant or breastfeeding women

Prior malignancy, other than FL, unless free from disease / treatment for greater than or equal to 5 years. Exceptions include localised non-melanoma skin cancer and carcinoma in situ., and prostate cancer TNM Stage T1a or T1b

Patients at high risk of venous thromboembolism who are not willing to take prophylaxis

Patients with any psychiatric , social or geographic circumstance that would preclude protocol compliance


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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