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LymphomaPhase 2NCT01307605

Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma

A Phase 2 study testing Rituximab and lenalidomide in people with Lymphoma, run by Swiss Cancer Institute at 33 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Rituximab and lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
33 sitesin 3 countries
Study dates
9 Feb 2011to 25 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

Switzerland18 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Kantonsspital Baden

    Baden, 5404

  • Saint Claraspital AG

    Basel, 4016

  • Universitaetsspital-Basel

    Basel, 4031

  • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    Bellinzona, 6500

  • Inselspital Bern

    Bern, 3010

  • Spitalzentrum Oberwallis - Brig

    Brig, 3900

  • Kantonsspital Bruderholz

    Bruderholz, 4101

  • Kantonsspital Graubuenden

    Chur, 7000

  • University Hospital

    Geneva, 1211

  • Kantonsspital Liestal

    Liestal, 4410

  • Kantonsspital Olten

    Olten, 4600

  • Kantonsspital - St. Gallen

    Sankt Gallen, 9007

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, 8401

  • Klinik Hirslanden

    Zurich, 8032

  • City Hospital Triemli

    Zurich, 8063

  • UniversitaetsSpital Zuerich

    Zurich, 8091

Other trials in Switzerland

Sweden9 sites

  • Sahlgrenska University Hospital

    Gothenburg, S-413 45

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Sunderbyn Hospital

    Luleå, 95128

  • Lund University Hospital

    Lund, SE-22185

  • Karolinska University Hospital - Huddinge

    Stockholm, S-141 86

  • Karolinska University Hospital - Solna

    Stockholm, S-171 76

  • Sundsvall Hospital

    Sundsvall, 85186

  • Norrlands University Hospital

    Umeå, S-90185

  • Uppsala University Hospital

    Uppsala, SE-75185

Other trials in Sweden

Norway6 sites

  • Haukeland Hospital - University of Bergen

    Bergen, N-5021

  • Sorlandet Sykehus HF Kristiansand

    Kristiansand, 4604

  • Ullevaal University Hospital

    Oslo, 0424

  • Helse Stavanger HF

    Stavanger, 4068

  • University Hospital of North Norway - Tromso

    Tromsø, 9038

  • St. Olavs University Hospital

    Trondheim, 7006

Other trials in Norway

About this study

Official title: Rituximab Plus Lenalidomide or Rituximab Monotherapy for Untreated Patients With Follicular Lymphoma in Need of Therapy. A Randomized, Open-Label, Multicenter Phase II Trial.

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.

Read the detailed 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.

Conditions
Lymphoma
Being tested
Rituximab, lenalidomide
Keywords
contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabBiological

    Also called Rituximab (MabThera)

    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

  • lenalidomideDrug

    Also called Lenalidomide (Revlimid)

    Lenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.

Study groups in NCT01307605
Study groupRoleWhat they receive
RituximabActive comparatorRituximab (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
Receives: Biological: Rituximab
Rituximab plus LenalidomideActive comparatorLenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.
Receives: Drug: lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response (CR)

    The evaluation of CR is outlined in Appendix 1 Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma.

    Measured: at week 23

Secondary outcomes (6)

  1. 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)

    Measured: within 24 weeks

  2. 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)

    Measured: within 12 weeks

  3. 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

    Measured: until disease progression, for up to 10 years after randomization

  4. 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.

    Measured: until off-trial therapy administration, for up to 10 years after randomization

  5. 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.

    Measured: every 6 months for up to 10 years after randomization

  6. Adverse events, including laboratory abnormality assessments and vital signs

    This will be evaluated using the NCI CTCAE v4.0

    Measured: from inclusion until 30 days after treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study start9 Feb 2011
  3. Primary completion20 Jun 2014
  4. Study completion25 Jan 2023

Why it stopped: It was decided by the trial team to stop the collection of follow up data in trial SAKK 35/10.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307605
Sponsor's protocol ID
SAKK 35/10
Other IDs
SWS-SAKK-35-10, 2010-021253-39, CELGENE-SWS-SAKK-35/10
Status last verified
Jun 2023
First submitted
1 Mar 2011
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Menter T, Tzankov A, Zucca E, Kimby E, Hultdin M, Sundstrom C, Beiske K, Cogliatti S, Banz Y, Cathomas G, Karjalainen-Lindsberg ML, Grobholz R, Mazzucchelli L, Sander B, Hawle H, Hayoz S, Dirnhofer S. Prognostic implications of the microenvironment for follicular lymphoma under immunomodulation therapy. Br J Haematol. 2020 May;189(4):707-717. doi: 10.1111/bjh.16414. Epub 2020 Feb 3.

    PubMed 32012230

  • Zucca E, Rondeau S, Vanazzi A, Ostenstad B, Mey UJM, Rauch D, Wahlin BE, Hitz F, Hernberg M, Johansson AS, de Nully Brown P, Hagberg H, Ferreri AJM, Lohri A, Novak U, Zander T, Bersvendsen H, Bargetzi M, Mingrone W, Krasniqi F, Dirnhofer S, Hayoz S, Hawle H, Vilei SB, Ghielmini M, Kimby E; Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group. Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy. Blood. 2019 Jul 25;134(4):353-362. doi: 10.1182/blood-2018-10-879643. Epub 2019 May 17.

    PubMed 31101627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and lenalidomide in people with Lymphoma, run by Swiss Cancer Institute at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Switzerland, Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: It was decided by the trial team to stop the collection of follow up data in trial SAKK 35/10.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) (time frame: at week 23). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01307605, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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