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A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)



- To determine the response rate in patients with relapsed or refractory follicular or
small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab.


- To determine the time to disease progression, duration of response, and overall
survival of these patients.

- To determine the tolerability of this regimen in these patients.

- To assess changes in serum cytokines before and after treatment and correlate these
changes with response.

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity. Patients also receive rituximab
IV on days 15 and 22 of course 1 and on days 1 and 8 of course 2. Patients who do not
achieve complete response after 2 courses of rituximab may receive up to 4 additional doses
of rituximab once weekly for 4 weeks.

Blood samples are collected at baseline and after treatment for cytokine analysis.

After completion of study treatment, patients are followed at 30 days and then every 3
months thereafter.

Inclusion Criteria


- Histologically* confirmed non-Hodgkin lymphoma, including one of the following

- Grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes
present) follicular lymphoma according to WHO criteria

- Small lymphocytic lymphoma

- NOTE: *Bone marrow biopsies as the sole means of diagnosis are not acceptable, but
they may be submitted in conjunction with nodal biopsies or extra-nodal biopsies;
fine-needle aspirates are not acceptable for diagnosis.

- At least one measurable lesion according to RECIST criteria

- Measurable lymphadenopathy to follow with serial exam and/or imaging

- Relapsed or refractory disease

- Must have evidence of disease progression during or after last treatment

- If previously treated with rituximab, must have disease progression within
6 months of last therapy OR if there was a prior response to rituximab,
rituximab must not have been given within the past 6 months

- No evidence of CNS metastases


- ECOG performance status 0-2

- Life expectancy > 3 months

- Absolute neutrophil count ≥ 1,000/mm³

- Platelet count ≥ 75,000/mm³

- Serum creatinine ≤ 2.0 mg/dL

- Total bilirubin ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double method contraception for ≥ 28 days before,
during, and for ≥ 28 days after completion of study therapy

- HIV negative

- Able to swallow lenalidomide

- Able to take aspirin (81 or 325 mg) daily or low molecular weight heparin as
prophylactic anticoagulation

- No neuropathy ≥ grade 2

- No known active hepatitis A, B, or C

- No other malignancies within the past 5 years except treated basal cell or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix or breast

- No serious medical condition, laboratory abnormality, or psychiatric illness that
would preclude the patient from signing the informed consent form

- No condition, including the presence of laboratory abnormalities, that would preclude
study participation or confound the ability to interpret study data

- No known hypersensitivity to thalidomide or rituximab

- No development of erythema nodosum, if characterized by a desquamating rash while
taking thalidomide or similar drugs


- See Disease Characteristics

- At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal
therapy, or surgery

- More than 28 days since prior experimental drug or therapy

- No prior lenalidomide

- No other concurrent anticancer agents or treatments, including radiotherapy or

- No other concurrent investigational agents

- No concurrent sargramostim (GM-CSF)

- No other concurrent antilymphoma therapy, including steroids (except for the
treatment of hypersensitivity reactions)

Type of Study:


Study Design:

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

Outcome Measure:

Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months

Outcome Description:

Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Joseph M. Tuscano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

July 2015

Related Keywords:

  • Lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of California Davis Cancer Center Sacramento, California  95817