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LymphomaPhase 1/2NCT00987493

Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma

A Phase 1/2 study testing rituximab, bendamustine hydrochloride and lenalidomide in people with Lymphoma, run by Swiss Cancer Institute at 16 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 cell-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, bendamustine hydrochloride and lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
16 sitesSwitzerland
Study dates
Sep 2009to Apr 2016
Phase
Phase 1/2
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 aggressive B-cell non-Hodgkin lymphoma, including any of the following:
  • Diffuse large B-cell lymphoma (variants, subgroups, and subtypes according to WHO criteria)
  • Transformed follicular lymphoma
  • Follicular lymphoma grade 3B
  • Meets 1 of the following criteria:
  • Not eligible for anthracycline-based first-line chemotherapy (e.g., R-CHOP)
  • Refractory disease after at least 2 courses of anthracycline-based immune-chemotherapy (e.g., R-CHOP) and patient is not eligible for intensive salvage regimens including HDT with ASCT
  • Relapsed disease after at least 1 treatment with curative intention and patient is not eligible for intensive salvage regimens including HDT with ASCT
  • Relapsed disease after HDT with ASCT
  • Measurable disease defined as ≥ 1 lesion ≥ 2 cm in greatest transverse diameter on cross-sectional imaging
  • Must complete pre-treatment cancer-specific geriatric assessment and/or quality-of-life questionnaire (phase II only)
  • No known CNS involvement
  • Diagnostic procedures required only in case of specific symptoms

PATIENT CHARACTERISTICS:

  • WHO performance status (PS) 0-2
  • WHO PS 3 allowed in case of lymphoma-related impaired general condition (phase II only)
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2 times ULN
  • Alkaline phosphatase 2 times ULN
  • Creatinine clearance > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • EF ≥ 40% by echocardiography or MUGA scan
  • Negative HIV test
  • Able to comply with and geographic proximity to allow proper staging and study follow-up
  • Agree to follow the special prescribing requirements for lenalidomide
  • No other malignancy within the past 3 years except adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
  • No unstable cardiovascular disease
  • No psychiatric disorder precluding understanding of information on trial-related topics, giving informed consent, or interfering with compliance for oral drug intake
  • No serious underlying medical condition that, in the judgement of the investigator, could impair the ability of the patient to participate in the trial including, but not limited to, any of the following conditions:
  • Acute or ongoing infection
  • Uncontrolled diabetes mellitus
  • Active autoimmune disease
  • No known hypersensitivity to any component of the trial drugs

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No experimental drugs within the past 30 days
  • No concurrent drugs contraindicated with the trial drugs according to the Swissmedic-approved product information
  • No other concurrent anticancer or investigational drugs or radiotherapy

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Switzerland16 sites

  • Kantonsspital Baden

    Baden, CH-5404

  • Universitaetsspital Basel

    Basel, 4031

  • St. Claraspital AG

    Basel, CH-4016

  • Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • Inselspital Bern

    Bern, 3010

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Kantonsspital Graubünden

    Chur, 7000

  • Hopital Fribourgeois

    Fribourg, 1708

  • Hôpitaux Universitaires de Genève HUG

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Liestal

    Liestal, CH-4410

  • Kantonsspital Olten

    Olten, CH-4600

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Kantonsspital Winterthur

    Winterthur, 8401

  • Stadtspital Triemli

    Zurich, 8063

  • Universitäts Spital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Rituximab, Bendamustine and Lenalidomide in Patients With Aggressive B-cell Lymphoma Not Eligible for High Dose Chemotherapy or Anthracycline-Based Therapy. A Phase I/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 cell-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together with bendamustine hydrochloride and lenalidomide may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab together with bendamustine hydrochloride and lenalidomide in treating patients with aggressive B-cell lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the maximum-tolerated dose of the combination of rituximab, bendamustine hydrochloride, and lenalidomide in patients with aggressive B-cell lymphoma not eligible for anthracycline-based first-line treatment or intensive regimens including high-dose therapy (HDT) followed by autologous stem cell transplantation (ASCT) in refractory or relapsing disease, or as treatment for patients relapsing after HDT with ASCT. (phase I).
  • To identify the recommended dose of this regimen for a phase II study (phase I).
  • To determine the efficacy and safety of this regimen in these patients (phase II).

Secondary

  • To assess the quality of life (QOL) of patients treated with this regimen (phase II).
  • To evaluate the usefulness and feasibility of the SAKK Cancer-Specific Geriatric Assessment (C-SGA) in patients treated with this regimen (phase II).
  • To assess the association between WHO performance status, QOL indicators, and SAKK C-SGA scores (phase II).
  • To describe changes in SAKK C-SGA scores from pre- to post-treatment and in QOL (phase II).

OUTLINE: This is a multicenter, phase I dose-escalation study of bendamustine hydrochloride and lenalidomide followed by a phase II study.

Patients receive rituximab IV on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1-2, and oral lenalidomide on days 1-21. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients on phase II study complete the SAKK Cancer-Specific Geriatric Assessment at baseline and after completion of course 1. Patients also complete quality-of-life questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed for up to 2 years.

Conditions
Lymphoma
Being tested
rituximab, bendamustine hydrochloride, lenalidomide
Keywords
recurrent adult diffuse large cell lymphoma, recurrent grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

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

  • rituximabBiological

    Also called MabThera, Rituxan

    day 1 at a fixed dose of 375mg/m2

  • bendamustine hydrochlorideDrug

    Also called Cephalon

    Bendamustine at day 1 and 2 according to the dose escalation in phase I, and at the recommended dose in phase II: 70mg/m2.

  • lenalidomideDrug

    Also called Revlimid

    Lenalidomide at days 1-21 according to the dose escalation in phase I, and at the recommended dose in phase II: 10mg

Study groups in NCT00987493
Study groupRoleWhat they receive
Treatment with rituximab, bendamustine and lenalidomideExperimentalNot described
Receives: Biological: rituximab; Drug: bendamustine hydrochloride; Drug: lenalidomide

What is being measured

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

  1. Dose-limiting toxicity (phase I)

    Measured: at 4 weeks.

  2. Maximum-tolerated dose (phase I)

    Measured: at the end of phase I (31 August 2011)

  3. Objective response (complete and partial response) (phase II)

    Measured: phase II (3 years)

Secondary outcomes (9)

  1. Adverse events according to NCI CTCAE v. 3.0

    Measured: All AEs will be assessed according to NCI CTCAE v3.0 until 30 days after trial therapy end.

  2. Event-free survival (phase II)

    Measured: up to 30 months for each patient.

  3. Response duration (phase II)

    From the time when criteria for response (CR/CRu or PR) are met, until documentation of relapse or progression thereafter. Only patients with a response (CR/ CRu or PR) shall be included in this analysis. Patients with no disease progression or relapse shall be censored at the last time they were known to be in remission

    Measured: up to 30 months for each patient.

  4. Time to progression (phase II)

    Defined as the time from registration until documented lymphoma progression or death as a result of lymphoma. Patients not experiencing an event will be censored at the last time they were known to be in remission

    Measured: up to 30 months for each patient.

  5. Overall survival (phase II)

    Measured: up to 30 months for each patient.

  6. Quality of life

    Measured: approx. 5 months for each patient.

  7. Usefulness and feasibility of the SAKK C-SGA

    Measured: End of phase II (excluding follow-up) at 3 years.

  8. Association between WHO performance status, QOL indicators, and SAKK C-SGA scores

    Measured: End of phase II (excluding follow-up) at 3 years.

  9. Progression Free Survival (PFS)

    Time from registration until one of the following events (whichever occurs first):

    • Relapse or progression assessed according to the International Workshop NHL criteria (1999)
    • Death of any cause

    Measured: up to 30 months for each patient.

Timeline

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

  1. First posted1 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2014
  4. Study completionApr 2016

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00987493
Sponsor's protocol ID
SAKK 38/08
Other IDs
SWS-SAKK-38/08, 2009-012559-67, EU-20976, CDR0000652127, 2009
Status last verified
May 2019
First submitted
30 Sep 2009
Last updated
15 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hitz F, Zucca E, Pabst T, Fischer N, Cairoli A, Samaras P, Caspar CB, Mach N, Krasniqi F, Schmidt A, Rothermundt C, Enoiu M, Eckhardt K, Berardi Vilei S, Rondeau S, Mey U. Rituximab, bendamustine and lenalidomide in patients with aggressive B-cell lymphoma not eligible for anthracycline-based therapy or intensive salvage chemotherapy - SAKK 38/08. Br J Haematol. 2016 Jul;174(2):255-63. doi: 10.1111/bjh.14049. Epub 2016 Mar 28.

    PubMed 27018242

  • Hitz F, Fischer N, Pabst T, Caspar C, Berthod G, Eckhardt K, Berardi Vilei S, Zucca E, Mey U; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. Rituximab, bendamustine, and lenalidomide in patients with aggressive B cell lymphoma not eligible for high-dose chemotherapy or anthracycline-based therapy: phase I results of the SAKK 38/08 trial. Ann Hematol. 2013 Aug;92(8):1033-40. doi: 10.1007/s00277-013-1751-z. Epub 2013 Apr 17.

    PubMed 23592273

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing rituximab, bendamustine hydrochloride and lenalidomide in people with Lymphoma, run by Swiss Cancer Institute at 16 sites in Switzerland.

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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Switzerland. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-limiting toxicity (phase I) (time frame: at 4 weeks.). The study lists 3 primary outcomes in all. 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 NCT00987493, 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 15 May 2019.

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