Clinical trial NCT00848328: Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
Official title: A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Keywords: recurrent small lymphocytic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2009-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer 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. Giving lenalidomide together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.

Detailed description: OBJECTIVES:

Primary

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

Secondary

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

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

  * 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

PATIENT CHARACTERISTICS:

* 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

PRIOR CONCURRENT THERAPY:

* 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 thalidomide
* No other concurrent investigational agents
* No concurrent sargramostim (GM-CSF)
* No other concurrent antilymphoma therapy, including steroids (except for the treatment of hypersensitivity reactions)

Primary outcomes:
measure: Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Time to disease progression
timeFrame: Up to two years
measure: Tolerability (type, frequency, severity, and relationship of adverse events to study treatment as assessed by NCI CTCAE v3.0)
timeFrame: Up to two years
measure: Duration of response
timeFrame: Up to two years
measure: Overall survival
timeFrame: Up to two years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Joseph M. Tuscano, MD
role: PRINCIPAL_INVESTIGATOR
References: