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Lenalidomide Therapy In Previously Untreated, Advanced Stage Follicular Lymphoma

Phase 1/Phase 2
18 Years
Not Enrolling
Lymphoma, Follicular Lymphoma

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Trial Information

Lenalidomide Therapy In Previously Untreated, Advanced Stage Follicular Lymphoma

Inclusion Criteria:

- Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, (as
defined in the WHO classification3) as reviewed by a hematopathologist at Memorial

- No prior treatment for lymphoma permitted.

- Measurable or evaluable disease is permitted; at least one peripheral site amenable
to FNAs

- Laboratory test results within these ranges

- Absolute neutrophil count ≥ 2000

- Platelet count ≥ 150,000

- Creatinine clearance of ≥ 60 mL/min (may be actual or calculated by Cockroft-Gault

- Total bilirubin 1.5 x ULN

- AST (SGOT) and ALT (SGPT) ≤ 3 x ULN. Karnofsky performance status > 70%

- The patient may not have a previous history of radiation therapy.

- Patient or guardian must be able to sign voluntary written consent.

- Male or female patients 18 years of age or greater.

- Females of childbearing potential (FCBP)† must have a negative serum pregnancy test
with a sensitivity of at least 50 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 Fetal Exposure, Pregnancy Testing
Guidelines and Acceptable Birth Control Methods (Appendix B), and also Appendix C:
Education and Counseling Guidance Document.

- Able to take aspirin (81 mg, if not already on aspirin) daily as prophylactic
anticoagulation (Patients intolerant to ASA may use low molecular weight heparin).
Although not recommended as prophylactic anti-coagulation, warfin may be used with
clode monitoring of INR.

Exclusion Criteria:

- Histologic diagnosis of follicular grade 3B or aggressive non-Hodgkin's lymphoma.

- Histologic evidence of transformation from low grade/indolent NHL to aggressive NHL.

- PET uptake in any of the involved sites greater than 12 (suggesting histologic

- Regional lymphoma (peripheral stages I and II) eligible for involved field
irradiation.Staging fulfills criteria for no initial treatment according to GELF
criteria2 for advanced stage disease (not peripheral stage I and II amenable to
involved field irradiation) . None of the following should be present:

1. A nodal or extranodal mass with a diameter of >7 cm,

2. Involvement of at least three nodal sites [each with a diameter of >3 cm],

3. Systemic symptoms,

4. Symptomatic splenomegaly, or

5. Ureteral compression.

- Patients with a known history of HIV, Hepatitis B or C seropositivity.

- Patients with stool positive for H. Pylori (these patients are eligible for protocol

- Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome (see
Appendix E). Subjects may be enrolled upon correction of electrolyte abnormalities.

- Patients who require therapy with systemic corticosteroids.

- Prior history of malignancy within the past five years or a concurrent malignancy,
with the exceptions of cutaneous basal cell carcinoma or carcinoma in situ of the
uterine cervix.

- Pregnant or lactating women.

Type of Study:


Study Design:

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

Outcome Measure:

Response rate (CR + PR).

Outcome Description:

The primary objective of this study is to evaluate lenalidomide in previously untreated patients with advanced stage follicular lymphoma who do not require active lymphoma therapy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Carol Portlock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Lymphoma
  • Follicular Lymphoma
  • Lenalidomide
  • 10-022
  • Lymphoma
  • Lymphoma, Follicular