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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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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.


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity (phase I)

Outcome Time Frame:

at 4 weeks.

Safety Issue:

Yes

Principal Investigator

Felicitas Hitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kantonsspital St. Gallen

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 38/08

NCT ID:

NCT00987493

Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, B-Cell

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