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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01307605
Other study ID # SAKK 35/10
Secondary ID SWS-SAKK-35-1020
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 9, 2011
Est. completion date January 25, 2023

Study information

Verified date June 2023
Source Swiss Group for Clinical Cancer Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known whether rituximab is more effective when given alone or together with lenalidomide in treating patients with follicular lymphoma. PURPOSE: This randomized phase II trial is studying rituximab to see how well it works compared with giving rituximab together with lenalidomide in treating patients with previously untreated follicular lymphoma.


Description:

OBJECTIVES: Primary - To determine the activity of rituximab in combination with lenalidomide versus rituximab alone in patients with previously untreated follicular lymphoma in need of therapy. Secondary - To determine the safety of these regimens in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (grades 1 or 2 vs 3a), presence of bulky disease (defined as masses ≥ 6 cm) (yes vs no), Follicular Lymphoma International Prognostic Index score (1 or 2 vs ≥ 3), and participating centers. Patients are randomized to 1 of 2 treatment arms. - Arm A: Patients receive rituximab IV on day 1 in weeks 1, 2, 3, 4 and weeks 12, 13, 14, 15 in the absence of disease progression or unacceptable toxicity. - Arm B: Patients receive rituximab IV as in arm A. Patients also receive oral lenalidomide once daily, starting 14 days before first rituximab administration and last until 14 days after the last rituximab administration, in the absence of disease progression or unacceptable toxicity. All patients undergo restaging at week 10. Patients who show less than a minimal response (i.e., reduction of more than 25% in sum of product of diameters [SPD]) are off study treatment and transferred to the follow-up phase. Patients undergo a second restaging in week 23. Some patients may undergo biopsies and blood and bone marrow sample collection periodically for biomarker studies. After completion of study treatment, patients are followed up periodically for 20 years.


Recruitment information / eligibility

Status Terminated
Enrollment 154
Est. completion date January 25, 2023
Est. primary completion date June 20, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS: - Histologically confirmed follicular lymphoma - Stage III or IV disease OR stage II disease not suitable for radiotherapy - Grades 1, 2, or 3a disease - Previously untreated disease - CD20-positive disease - Patients in need of systemic therapy, meeting at least 1 of the following criteria: - Symptomatic enlarged lymph nodes, spleen, or other lymphoma manifestations - Bulky disease = 6 cm in long diameter - Clinically significant progression over at least 6 months of any tumor lesion - Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelet count < 100 x 10^9/L) due to lymphoma - Clinically significant progressive decrease in hemoglobin or platelet count due to lymphoma - B-symptoms, weight loss > 10% within the past 6 months, drenching night sweats, or fever > 38°C not due to infection - At least one two-dimensionally measurable lesion with longest transverse diameter > 10 mm - Paraffin-embedded tumor tissue available - No known CNS involvement PATIENT CHARACTERISTICS: - WHO performance status 0-2 - EF = 50% for patients with a history of cardiac disease or older than 70 years - Neutrophil count = 1.5 x 10^9/L - Platelet count = 100 x 10^9/L - Bilirubin = 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome) - ALT = 2.5 x ULN - Alkaline phosphatase = 2.5 x ULN - Creatinine clearance = 30 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception 4 weeks prior to, during, and for 12 months after completion of study therapy - Must be compliant and geographically proximal to allow for proper staging and follow-up - No serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes) - No malignancy within the past 3 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer - No psychiatric disorder precluding understanding information of trial-related topics, giving informed consent, or interfering with compliance for oral drug intake - No known hypersensitivity to trial drugs or hypersensitivity to any other components of the trial drugs - No known HIV positivity or hepatitis C infection - No serological evidence of current or past hepatitis B infection, unless the serological findings are clearly due to vaccination PRIOR CONCURRENT THERAPY: - No prior systemic therapy for this disease - At least 3 months since prior radiotherapy - At least 30 days since prior treatment in another clinical trial - At least 4 weeks since prior and no concurrent corticosteroids unless administered as prophylaxis in at-risk patients for = 3 days or at a dose equivalent to prednisone = 15 mg/day, for indications other than lymphoma or lymphoma-related symptoms - No concomitant drugs contraindicated for use with the trial drugs - No other concurrent experimental drugs or anticancer therapy - No other concurrent investigational treatments

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Rituximab
Rituximab (MabThera®) will be administered for a maximum of 8 infusions at weeks 1, 2, 3, 4 and again at weeks 12, 13, 14, 15 if the first restaging at week 10 (+/- 1 week) shows a partial response with at least more than 25% reduction in sum of product of diameters
Drug:
lenalidomide
Lenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.

Locations

Country Name City State
Norway Haukeland Hospital - University of Bergen Bergen
Norway Sorlandet Sykehus HF Kristiansand Kristiansand
Norway Ullevaal University Hospital Oslo
Norway Helse Stavanger HF Stavanger
Norway University Hospital of North Norway - Tromso Tromso
Norway St. Olavs University Hospital Trondheim
Sweden Sahlgrenska University Hospital Göteborg
Sweden University Hospital of Linkoping Linkoping
Sweden Sunderbyn Hospital Lulea
Sweden Lund University Hospital Lund
Sweden Karolinska University Hospital - Huddinge Stockholm
Sweden Karolinska University Hospital - Solna Stockholm
Sweden Sundsvall Hospital Sundsvall
Sweden Norrlands University Hospital Umea
Sweden Uppsala University Hospital Uppsala
Switzerland Kantonsspital Aarau Aarau
Switzerland Kantonsspital Baden Baden
Switzerland Saint Claraspital AG Basel
Switzerland Universitaetsspital-Basel Basel
Switzerland Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni Bellinzona
Switzerland Inselspital Bern Bern
Switzerland Spitalzentrum Oberwallis - Brig Brig
Switzerland Kantonsspital Bruderholz Bruderholz
Switzerland Kantonsspital Graubuenden Chur
Switzerland University Hospital Geneva
Switzerland Kantonsspital Liestal Liestal
Switzerland Kantonsspital Olten Olten
Switzerland Kantonsspital - St. Gallen St. Gallen
Switzerland Regionalspital Thun
Switzerland Kantonsspital Winterthur Winterthur
Switzerland City Hospital Triemli Zurich
Switzerland Klinik Hirslanden Zurich
Switzerland UniversitaetsSpital Zuerich Zurich

Sponsors (1)

Lead Sponsor Collaborator
Swiss Group for Clinical Cancer Research

Countries where clinical trial is conducted

Norway,  Sweden,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete response (CR) The evaluation of CR is outlined in Appendix 1 Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma. at week 23
Secondary Best overall response (OR) OR is defined as either:
the disappearance of all evidence of disease (CR or CRu)
the regression of measurable disease with no new sites (PR)
within 24 weeks
Secondary Best Overall response (OR) OR is defined as either:
the disappearance of all evidence of disease (CR or CRu)
the regression of measurable disease with no new sites (PR)
within 12 weeks
Secondary Progression-free survival PFS will be calculated from randomization until the first event of interest:
disease progression or relapse according to criteria of Cheson et a.l 1999
death from any cause
until disease progression, for up to 10 years after randomization
Secondary Time to first off-trial anti-lymphoma therapy This will be calculated from randomization until the start of the first off-trial anti-lymphoma treatment.
Patients not receiving any off-trial anti-lymphoma treatment will be censored at the last follow-up visit.
until off-trial therapy administration, for up to 10 years after randomization
Secondary Overall survival OS will be calculated from randomization until death. Patients not experiencing an event will be censored at the last date they were known to be alive. every 6 months for up to 10 years after randomization
Secondary Adverse events, including laboratory abnormality assessments and vital signs This will be evaluated using the NCI CTCAE v4.0 from inclusion until 30 days after treatment discontinuation
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