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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987493
First Posted: October 1, 2009
Last Update Posted: August 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
September 30, 2009
October 1, 2009
August 12, 2016
September 2009
April 2014   (Final data collection date for primary outcome measure)
  • Dose-limiting toxicity (phase I) [ Time Frame: at 4 weeks. ]
  • Maximum-tolerated dose (phase I) [ Time Frame: at the end of phase I (31 August 2011) ]
  • Objective response (complete and partial response) (phase II) [ Time Frame: phase II (3 years) ]
  • Dose-limiting toxicity (phase I)
  • Maximum-tolerated dose (phase I)
  • Objective response (complete and partial response) (phase II)
Complete list of historical versions of study NCT00987493 on ClinicalTrials.gov Archive Site
  • Adverse events according to NCI CTCAE v. 3.0 [ Time Frame: All AEs will be assessed according to NCI CTCAE v3.0 until 30 days after trial therapy end. ]
  • Event-free survival (phase II) [ Time Frame: up to 30 months for each patient. ]
  • Response duration (phase II) [ Time Frame: up to 30 months for each patient. ]
    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
  • Time to progression (phase II) [ Time Frame: up to 30 months for each patient. ]
    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
  • Overall survival (phase II) [ Time Frame: up to 30 months for each patient. ]
  • Quality of life [ Time Frame: approx. 5 months for each patient. ]
  • Usefulness and feasibility of the SAKK C-SGA [ Time Frame: End of phase II (excluding follow-up) at 3 years. ]
  • Association between WHO performance status, QOL indicators, and SAKK C-SGA scores [ Time Frame: End of phase II (excluding follow-up) at 3 years. ]
  • Progression Free Survival (PFS) [ Time Frame: up to 30 months for each patient. ]

    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
  • Adverse events according to NCI CTCAE v. 3.0
  • Event-free survival (phase II)
  • Progression-free survival (phase II)
  • Response duration (phase II)
  • Time to progression (phase II)
  • Overall survival (phase II)
  • Quality of life
  • Usefulness and feasibility of the SAKK C-SGA
  • Association between WHO performance status, QOL indicators, and SAKK C-SGA scores
Not Provided
Not Provided
 
Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma
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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
  • Biological: rituximab
    day 1 at a fixed dose of 375mg/m2
    Other Names:
    • MabThera
    • Rituxan
  • Drug: bendamustine hydrochloride
    Bendamustine at day 1 and 2 according to the dose escalation in phase I, and at the recommended dose in phase II: 70mg/m2.
    Other Name: Cephalon
  • Drug: lenalidomide
    Lenalidomide at days 1-21 according to the dose escalation in phase I, and at the recommended dose in phase II: 10mg
    Other Name: Revlimid
Experimental: Treatment with rituximab, bendamustine and lenalidomide
Interventions:
  • Biological: rituximab
  • Drug: bendamustine hydrochloride
  • Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
April 2016
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00987493
SAKK 38/08
SWS-SAKK-38/08
2009-012559-67 ( EudraCT Number )
EU-20976
CDR0000652127
No
Not Provided
Plan to Share IPD: No
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Principal Investigator: Felicitas Hitz, MD Cantonal Hospital of St. Gallen
Study Chair: Mey Ulrich, MD Kantonsspital Graubünden
Swiss Group for Clinical Cancer Research
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP