Study to compare the efficacy and safety of rituximab plus lenalidomide versus standart therapy with rituximab plus chemotherapy in subjects with previously untreated follicular lymphoma.

Phase 1

• Conditions: Stage II-IV follicular lymphoma grade 1-3a not previously treated; MedDRA version: 21.1Level: PTClassification code 10016908Term: Follicle centre lymphoma, follicular grade I, II, III stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10016910Term: Follicle centre lymphoma, follicular grade I, II, III stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10016909Term: Follicle centre lymphoma, follicular grade I, II, III stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-002792-42-DE
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-24
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1031

Inclusion Criteria

-Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a
-Have no prior systemic treatment for lymphoma.
-Must be in need of treatment
-Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated.
-Stage II, III or IV disease.
-Must be = 18 years and sign an informed consent.
-Performance status = 2 on the ECOG scale.
-Adequate hematological function
-Females of childbearing potential (FCBP) receiving lenalidomide must have two negative pregnancy tests . She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy.
-Male patients receiving lenalidomide must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation
-All patients receiving lenalidomide must have an understanding that the study drug could have a potential teratogenic risk.
-For all patients receiving Rituximab Women must not breast feed and must use effective contraception must not be pregnant and agree not to become pregnant during participation in the trial and during the 6 months thereafter. Men must agree not to father a child during participation in the trial and during the 6 months thereafter.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 649
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 382

Exclusion Criteria

-Clinical evidence of transformed lymphoma by investigator assessment
-Grade 3b follicular lymphoma
-Patients taking corticosteroids during the last 4 weeks
-Major surgery within 28 days prior to signing informed consent
-Seropositive for or active viral infection with hepatitis B virus (HBV)
-Known seropositive for, or active infection hepatitis C virus (HCV)
-Known seropositive for, or active viral infection with HIV
-Life expectancy < 6 months
-Known sensitivity or allergy to murine products
-Prior history of malignancies, unless the subject has been free of the disease for = 10 years. Exceptions include a history of previously treated Localized non-melanoma skin cancer or Carcinoma in situ of the cervix
-Prior use of lenalidomide
-Neuropathy > Grade 1
-Presence or history of CNS involvement by lymphoma
-Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis
-Uncontrolled intercurrent illness
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified