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Phase II Study of Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)
Non Hodgkin's Lymphoma

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Trial Information

Phase II Study of Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non Hodgkin's Lymphoma

Inclusion Criteria:

1. All patients must be informed of the investigative nature of the clinical trial and
given written informed consent in accordance with institutional and federal

2. Age greater than or equal to 18 years at the time of signing the informed consent

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Previously untreated, histologically confirmed indolent lymphoma including follicle
cell lymphoma, WHO classification, grade I or II, and marginal zone lymphoma. Bone
marrow biopsies as the sole means of diagnosis are not acceptable, but they may be
submitted in conjunction with nodal biopsies. Fine needle aspirates are not

5. At least one measurable lesion according to the International Working Group Response
criteria for lymphomas. There must be measurable lymphadenopathy to follow with
serial exam and/or imaging.

6. Submission of original biopsy for review by University of California Davis staff

7. ECOG performance status of 0 -2 at study entry.

8. No major organ dysfunction with laboratory test results within these ranges:

- Absolute neutrophil count greater than or equal to 1000 /uL

- Platelet count greater than or equal to 75 x 109/L

- Total bilirubin less than or equal to 2.0 mg/dL.

- HIV negative

- Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault
formula. See section below, "Dosing Regimen", regarding lenalidomide dose
adjustment for calculated creatinine clearance ≥ 30ml/min and < 60ml/min.

9. Life expectancy of greater than 3 months.

10. Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to
and again within 24 hours of starting lenalidomide and must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional effective method AT THE
SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also
agree to ongoing pregnancy testing. Men must agree to use a latex condom during
sexual contact with a FCBP even if they have had a successful vasectomy. All
patients must be counseled at a minimum of every 28 days about pregnancy precautions
and risks of fetal exposure.

11. Disease free of prior malignancies for greater than or equal to 5 years with
exception of currently treated basal cell, squamous cell carcinoma of the skin, or
carcinoma "in situ" of the cervix or breast

12. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients
who are intolerant to aspirin may use low molecular weight heparin).

13. Must be able to swallow lenalidomide capsules.

Exclusion Criteria:

1. Any prior treatment for Non-Hodgkin's Lymphoma.

2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

3. Pregnant or breast-feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide).

4. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

5. Use of any other experimental drug or therapy within 28 days of baseline.

6. Known hypersensitivity to thalidomide or rituximab.

7. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

8. Any prior use of lenalidomide.

9. Concurrent use of other anti-cancer agents or treatments.

10. Known positive for HIV

11. Known active hepatitis, type A, B or C.

12. Evidence for CNS metastatic disease

13. Subjects with ≥ Grade 2 neuropathy

Type of Study:


Study Design:

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

Outcome Measure:

Response rate to treatment

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 Tuscano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

June 2013

Related Keywords:

  • Non Hodgkin's Lymphoma
  • Lenalidomide
  • Rituximab
  • untreated indolent Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of California Davis Cancer Center Sacramento, California  95817