| Main | | Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. | | Register: | EUCTR | | Last refreshed on: | 16 May 2022 | | Main ID: | EUCTR2013-001245-14-PL | | Date of registration: | 03/04/2014 | | Prospective Registration: | Yes | | Primary sponsor: | | | Public title: | Study of combination of rituximab and lenalidomide treatment in patients with recurrent or unresponsive indolent (slow growing) lymphoma who have been treated previously | | Scientific title: | A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma. - The “AUGMENT” Trial | | Date of first enrolment: | 26/05/2014 | | Target sample size: | 350 | | Recruitment status: | Not Recruiting | | URL: | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001245-14 | | Study type: | Interventional clinical trial of medicinal product | | Study design: | Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2 | | Phase: | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no | | | Countries of recruitment | | Belgium | Brazil | China | Czech Republic | Czechia | France | Germany | Israel | | Italy | Japan | Poland | Portugal | Russian Federation | Spain | Turkey | United Kingdom | | United States | | Contacts | | Name: | ClinicalTrialDisclosure | | Address: | 9225 Indian Creek Parkway, Suite 900 66210 Overland Park, Kansas United States | | Telephone: | +1888260 1599 | | Email: | ClinicalTrialDisclosure@celgene.com | | Affiliation: | Celgene Corporation | | | Name: | ClinicalTrialDisclosure | | Address: | 9225 Indian Creek Parkway, Suite 900 66210 Overland Park, Kansas United States | | Telephone: | +1888260 1599 | | Email: | ClinicalTrialDisclosure@celgene.com | | Affiliation: | Celgene Corporation | | | Key inclusion & exclusion criteria | | Inclusion criteria: - Age =18 years at the time of signing the ICD - Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted. - Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a) - Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy: and must have received at least 2 previous doses of rituximab a) Systemic therapy does not include, for example: i. Local involved field radiotherapy for limited stage disease ii. H. Pylori eradication b) Prior investigational therapies will be allowed provided the subject has received at least one prior systemic therapy as discussed in a) - Documented relapsed, refractory or progressive disease after treatment with systemic therapy, and must not be rituximab-sensitive if had received rituximab or R-chemoregimen therapy refractory a) Relapsed lymphoma: relapsed after initial response of CR to prior therapy. b) Progressive lymphoma: PD after initial response of PR or SD to the prior therapy. c) Refractory lymphoma: Subject who received a non-rituximab containing systemic therapy and who experienced the best response of PD to this therapy is considered to have refractory lymphoma. d) Rituximab-refractoriness is defined as: i. Did not respond (at least a PR) to rituximab or R-chemoregimen therapy and/or ii. Time to disease progression < 6 months after last rituximab dose. e) Rituximab-sensitive MZL or FL defined as i. Responded (at least a PR) to rituximab or R-chemoregimen therapy and ii. Time to disease progression = 6 months after last rituximab dose f) Subjects with gastric MALT lymphoma and evidence of H. pylori (HP) infection must have documented non-response to antibiotic therapy as judged by a minimum follow up of 12 months after successful HP-eradication. - Investigator considers rituximab monotherapy appropriate - Bi-dimensionally measurable disease - Must be able to adhere to the study visit schedule and other protocol requirements - Eastern Cooperative Oncology Group (ECOG) Performance status = 2 - Fulfilled laboratory requirements - Willingness to follow pregnancy precautions - All subjects must: Have an understanding that the study drug could have a potential teratogenic risk; agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of study drug therapy; agree not to share study medication with another person; agree to be counseled about pregnancy precautions and risk of fetal exposure; females must agree to abstain from breastfeeding during study participation and for at least 28 days after lenalidomide/placebo discontinuation and according to the approved rituximab product/prescribing informationAre the trial subjects under 18? noNumber of subjects for this age range: F.1.2 Adults (18-64 years) yesF.1.2.1 Number of subjects for this age range 105F.1.3 Elderly (>=65 years) yesF.1.3.1 Number of subjects for this age range 245 Exclusion criteria: - Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma - Subjects taking corticosteroids during the last week, unless administered at a dose equivalent to = 20 mg/day prednisone or prednisolone - Major surgery (excluding lymph node or bone marrow biopsy) within 28 days prior to signing informed consent - Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks or use of radioimmunotherapy within 6 months - Known seropositive for or active viral infection with hepatitis B virus (HBV), human immunodeficiency virus (HIV) - Known seropositive for or active infection with hepatitis C virus (HCV) - Hepatitis C virus (HCV) positive subjects with chronic HCV hepatitis or subjects with an active HCV infection requiring anti-viral medication (at time of randomization). (HCV positive subjects who do not have active HCV hepatitis and are otherwise acceptable candidates for the study treatment, as documented by the investigator, are eligible. The Investigator must confirm that the patient does not have an active HCV infection or unacceptable liver damage as documented by one of the following options: liver ultrasound for fibrosis, liver biopsy, zero RNA viral load, or other local practice test.) - Life expectancy < 6 months - Known sensitivity or allergy to murine products - Presence or history of central nervous system involvement by lymphoma - Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it - Prior use of lenalidomide - Known allergy to thalidomide - Neuropathy > Grade 1 - Uncontrolled intercurrent illness. - Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Pregnant or lactating females. - Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study Age minimum: Age maximum: Gender: Female: yesMale: yes | | Health Condition(s) or Problem(s) studied | | Therapeutic area: Diseases [C] - Cancer [C04] | | Relapsed/refractory indolent lymphoma MedDRA version: 20.0 Level: LLT Classification code 10060707 Term: MALT lymphoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: HLT Classification code 10041650 Term: Splenic marginal zone lymphomas System Organ Class: 100000004851 MedDRA version: 20.0 Level: HLT Classification code 10029461 Term: Nodal marginal zone B-cell lymphomas System Organ Class: 100000004851 MedDRA version: 20.0 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 100000004851 | | Intervention(s) | | Trade Name: Revlimid 2.5mg, hard capsulesPharmaceutical Form: Capsule, hardINN or Proposed INN: LENALIDOMIDECAS Number: 191732-72-6Current Sponsor code: CC-5013Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 2.5-Pharmaceutical form of the placebo: Capsule, hardRoute of administration of the placebo: Oral useTrade Name: Revlimid 5mg, hard capsulesPharmaceutical Form: Capsule, hardINN or Proposed INN: LENALIDOMIDECAS Number: 191732-72-6Current Sponsor code: CC-5013Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 5-Pharmaceutical form of the placebo: Capsule, hardRoute of administration of the placebo: Oral useTrade Name: Revlimid 10mg, hard capsulesPharmaceutical Form: Capsule, hardINN or Proposed INN: LENALIDOMIDECAS Number: 191732-72-6Current Sponsor code: CC-5013Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 10-Pharmaceutical form of the placebo: Capsule, hardRoute of administration of the placebo: Oral useTrade Name: Revlimid 15mg, hard capsulesPharmaceutical Form: Capsule, hardINN or Proposed INN: LENALIDOMIDECAS Number: 191732-72-6Current Sponsor code: CC-5013Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 15-Pharmaceutical form of the placebo: Capsule, hardRoute of administration of the placebo: Oral useTrade Name: Revlimid 20mg, hard capsulesProduct Name: LenalidomideProduct Code: CC-5013Pharmaceutical Form: Capsule, hardINN or Proposed INN: LENALIDOMIDECAS Number: 191732-72-6Current Sponsor code: CC-5013Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 20-Pharmaceutical form of the placebo: Capsule, hardRoute of administration of t | | Primary Outcome(s) | | Timepoint(s) of evaluation of this end point: Years 1-3: Every 12 weeks (±1 week); Year 4: Every 16 weeks (±1 week); Year 5 onwards: Every 6 months (± 2 weeks). Assessments will be performed until progression or relapse | | Primary end point(s): Progression-free survival (PFS), as assessed by the IRC using the 2007 IWG criteria. | | Secondary Objective: •To compare the safety of rituximab plus lenalidomide versus rituximab plus placebo •To compare the efficacy of rituximab plus lenalidomide versus rituximab plus placebo using other parameters of efficacy: - Durable complete response rate (DCRR), overall response rate (ORR), and duration of response (DOR) and duration of complete response (DoCR) by IWG 2007 without PET. -OS, EFS, time to next anti-lymphoma treatment (TTNLT). | | Main Objective: To compare the efficacy of rituximab plus lenalidomide to rituximab plus placebo in subjects with relapsed/refractory indolent lymphoma. | | Secondary Outcome(s) | | Timepoint(s) of evaluation of this end point: Years 1-3: Every 12 weeks (±1 week); Year 4: Every 16 weeks (±1 week); Year 5 onwards: Every 6 months (± 2 weeks). Response assessments will be performed until progression or relapse with continued follow-up for survival and second primary malignancies up to 5 years from last subject randomized. | | Secondary end point(s): • Durable complete response rate (DCRR) • Overall Survival (OS), Overall Response Rate (ORR), Complete Response Rate (CR Rate), Duration of Response (DoR), Duration of Complete Response (DoCR), Event-Free Survival (EFS), Time to Next anti-Lymphoma Treatment (TTNLT), Safety | | Secondary ID(s) | | 2013-001245-14-GB | | CC-5013-NHL-007 | | Source(s) of Monetary Support | | Celgene Corporation | | Ethics review | | Status: Approved Approval date: 20/05/2014 Contact: | | Results | | Results available: | | Date Posted: | | Date Completed: | | URL: | | |
