Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT01316523
• Date of registration: 04/02/2011
• Prospective Registration: No
• Primary sponsor: University of California, Davis
• Public title: Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
• Scientific title: Phase II Study of Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non Hodgkin's Lymphoma
• Date of first enrolment: December 2010
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01316523
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Joseph Tuscano, MD
• Affiliation: University of California, Davis

Key inclusion & exclusion criteria

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
guidelines.

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

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
acceptable.

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 local staff hematopathologist.

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non Hodgkin's Lymphoma

Intervention(s)

Drug: Rituximab

Drug: Lenalidomide

Primary Outcome(s)

Response rate to treatment [Time Frame: 4 months]

Secondary Outcome(s)

Duration of response from start of therapy [Time Frame: Up to two years.]

Overall survival [Time Frame: Up to two years.]

Tolerability defined by frequency, severity and relationship of adverse events to study treatment [Time Frame: Up to two years.]

Time to progression [Time Frame: Up to two years.]

Secondary ID(s)

RV_PI_NHL_0488

215856

UCDCC#224

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene