InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

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

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.

Conditions

This trial is treating patients with Follicular Lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

RePLY

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Eligibility

Inclusion

 

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

Exclusion

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

Inclusion

  • 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.

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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

Participating hospitals

Recruiting hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.