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Rituximab and Lenalidomide vs Rituximab Alone as Maintenance After R-chemoterapy for Relapsed/Refractory FL Patients (FIL_RENOIR12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390869
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-chemotherapy (R-CHT) for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: R2-MANT Drug: R-MANT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Multicenter Trial Assessing Efficacy and Toxicity of a Combination of Rituximab and Lenalidomide (R2) vs Rituximab Alone as Maintenance After Chemoimmunotherapy With Rituximab-chemotherapy (R-CHT) for Relapsed/Refractory FL Patients Not Eligible for Autologous Transplantation (ASCT).
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: R2-MANT
A) Rituximab B) Lenalidomide
Drug: R2-MANT
A) Rituximab 375 mg/sqm on day 1 every 90 days for 8 cycles B) Lenalidomide (10 mg daily on days 1-21 every 28 days) for 24 cycles
Other Name: Rituximab and Lenalidomide (R2)

Active Comparator: R-MANT
A) Rituximab
Drug: R-MANT
A) Rituximab 375 mg/sqm on day 1 every 90 days for 8 cycles
Other Name: Rituximab (R)




Primary Outcome Measures :
  1. PFS [ Time Frame: 2 years from randomization ]
    Progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 2 years from randomization ]
    Overall survival

  2. Toxicity (Common Terminology Criteria for Adverse Event version 4.03 (CTCAE) [ Time Frame: 2 years from randomization ]
    classified according to definitions of Common Terminology Criteria for Adverse Event version 4.03 (CTCAE). It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions).

  3. Rate of molecular remission [ Time Frame: 2 years from randomization ]
    proportion of patients PCR negative for Bcl-2/IgH at different time-points including those achieving continuous MR in two or more consecutive time-points

  4. Rate of molecular conversion [ Time Frame: 2 years from randomization ]
    proportion of patients from baseline PCR-positivity to PCR-negativity.

  5. Rate of molecular relapse [ Time Frame: 2 years from randomization ]
    proportion of patients from PCR-negativity to PCR-positivity.

  6. Quality of Life(QoL) [ Time Frame: 2 years from randomization ]
    using the EORTC QLQ-C30C questionnaire

  7. The incremental cost-effectiveness ratio [ Time Frame: 2 years from randomization ]
    Quality Adjusted Life Years (QALYs) using Euro-Qol (EQ-5D) questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Follicular lymphoma grade I, II and IIIa according to the WHO classification. Rebiopsy at study entry is strongly encouraged but mandatory only in case of suspected transformation (elevated LDH or rapidly-growing disease or unusual relapse presentation).
  • First or second relapse or progression following R-chemotherapy (Rituximab maintenance and IF radiotherapy are not considered treatment lines).
  • Previous treatment with Bendamustine can be considered eligible if relapse occurred after ≥ 24 months.
  • Age >18 years.
  • Patients not eligible for high dose chemotherapy and ASCT because of: age ≥ 65 years, impaired PS or organ function due to major comorbidities or relapsed or refractory disease after previous ASCT before 65 of age.
  • Stage II, III or IV according to Ann Arbor at relapse.
  • Need of treatment according to SIE-SIES-GITMO guidelines for follicular lymphoma: stage II-IV with systemic symptoms, high tumor burden (i.e. >3 lymph nodes measuring >3 cm or a single lymph node >7 cm), extranodal disease, cytopenia due to marrow involvement, spleen involvement (≥16 cm by CT), leukemic phase, serious effusion, symptomatic or life endangering organ involvement, rapid lymphoma progression, consistently increased LDH levels.
  • Must be able to adhere to the study visit schedule and other protocol standards.
  • ECOG performance status ≤ 2 (except when PS impairment is related to lymphoma).
  • Be willing and able to comply with the protocol for the duration of the study.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L unless due to marrow involvement by lymphoma; and platelets count ≥ 75 x 109/L unless due to marrow involvement by lymphoma.
  • Calculated creatinine clearances ≥ 40 ml/min.
  • Agree to be using effective contraception for the entire treatment period according to standard guidelines for patients receiving lenalidomide

Exclusion Criteria:

  • Any lymphoma subtype other than FL including transformed FL
  • Grade 3b follicular lymphoma.
  • Radiotherapy within 3 months prior to study entry
  • Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
  • HIV positive serology. HBV and HCV positive patients will be not excluded from the study if the hepatic enzymes are within the ranges later defined. HBV occult carriers patients will be given lamivudine as prophylaxis starting one week before chemotherapy. HbsAg, HBcAb, HBV-DNA and HCV-RNA levels will be monitored twice every month in HCV or HBV positive patients.
  • Life expectancy < 6 months.
  • Known sensitivity or allergy to murine products.
  • Prior history of malignancies, other than follicular lymphoma, unless the subject has been free of the disease for > 3 years with the exception of adequately cured localized non-melanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast or incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
  • Prior use of lenalidomide.
  • Neuropathy > Grade 1.
  • Myocardial infarction within the last 6 months
  • Presence or history of CNS involvement by lymphoma.
  • Subjects who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis.
  • Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper limit of normal (ULN), except in subjects with documented liver involvement by lymphoma
  • Total bilirubin > 2.0 mg/dl (34 umol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390869


Contacts
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Contact: Claudia Peracchio, PhD +390131206129 gestionestudi@filinf.it
Contact: Raffaella Marcheselli, PhD +390594225845 rmarcheselli@filinf.it

Locations
Show Show 35 study locations
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Study Chair: Umberto Vitolo, MD A.O.U. Citta della Salute e della Scienza di Torino

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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT02390869    
Other Study ID Numbers: FIL_RENOIR12
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Keywords provided by Fondazione Italiana Linfomi ONLUS:
relapse
progression
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors