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Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).

Phase 2
18 Years
75 Years
Open (Enrolling)
Indolent Non Hodgkin Lymphoma

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Trial Information

Phase II Study of Lenalidomide in Combination With Rituximab (R) for the Treatment of Indolent Non Follicular Non Hodgkin Lymphoma (NHL).

Single arm, multicenter, open-label study divided in two phases: 1. Induction phase; 2.
Follow-up phase. Enrolled patients will start the induction phase and receive the courses of
R-Lenalidomide. At the end of the third cycle of R-Lenalidomide (week 12 of the study), the
patients will be evaluated for tumor response (complete assessment); the patients with
Progressive Disease (PD) will be withdrawn of the study. Two weeks after the end last
courses of R-Lenalidomide (week 26 of the study) patients will be evaluated for tumor
response (complete assessment). Patients with Complete Response (CR) and Partial Response
(PR), and with a stable disease will undergo the follow up phase, while patients with PD
will be withdrawn of the study.

Inclusion Criteria:

- Histological confirmed diagnosis of B-Cell non follicular NHL according to REAL/WHO
Classification: small lymphocytic lymphoma, lymphoplasmacytic lymphoma/Waldenstrom
macroglobulinemia, nodal marginal zone lymphoma, splenic marginal zone lymphoma,
extranodal non-gastric marginal zone lymphoma

- Availability of tissue biopsy mandatory when suspected pathological sites (nodal or
extranodal) are easily accessible and in presence of extranodal non-gastric
marginal or nodal marginal zone lymphoma diagnosis. In the other cases bone marrow
biopsy, when representative, may be considered sufficient for defining lymphoma

- Disease relapsing after >=2, but less than 4 prior lines of (immuno)chemotherapy. At
least one of previous treatment had to include rituximab

- Presence of at least one of the following criteria for the definition of active
disease: systemic symptoms, bulky disease, progressive marrow failure and/or
splenomegaly and/or lymph adenopathy

- Age 18-75

- Life expectancy > 6 months

- Eastern Cooperative Oncology Group (ECOG) <=2

- Left ventricular ejection fraction (LVEF) >=45%

- Creatinine clearance >= 50 mL/min calculated by Cockcroft-Gault estimation; patients
with creatinine clearance >= 30 and < 50 mL/min, at physician discretion could enter
the study starting at lenalidomide dose level -2 (10 mg)

- Total bilirubin up to 2 x upper limit of normal(ULN). Total bilirubin values higher
than 2 x ULN are admitted if related to localization of the disease

- Alkaline phosphatase up to 2 x ULN and transaminases up to 3 x ULN

- Female and male patients must agree to participate in pregnancy prevention program
signing informed Consent (paragraph 5.4.)

- Written informed Consent

Exclusion Criteria:

- Previously untreated patients

- Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)

- Women and men not agreeing to take adequate contraceptive precautions during and for
at least 4 weeks after cessation of therapy

- Pregnant or lactating women

- History of other malignancies within 3 years prior to study entry except for
adequately treated carcinoma in situ of the cervix or basal or squamous cell skin
cancer, low grade, early stage localized prostate cancer treated surgically with
curative intent, good prognosis ductal carcinoma in situ (DCIS) of the breast treated
with lumpectomy alone with curative intent

- Active bacterial, viral or fungal infection requiring systemic therapy

- Concurrent co-morbid medical condition which might exclude administration of therapy

- Cardiac insufficiency (NYHA grade III/IV)

- Myocardial infarction within 6 months of entry on the study

- Severe chronic obstructive pulmonary disease with hypoxemia

- Severe diabetes mellitus difficult to control with adequate insulin therapy

- Hypertension that is difficult to control

- Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault estimation

- Absolute neutrophil count (ANC) <= 1 x 109/L, unless due to lymphoma involvement and
not responding to 5 days of Granulocyte colony-stimulating factor (G-CFS) treatment

- Platelets count <=75.000/mm3, unless due to lymphoma involvement

- HIV and Hepatitis B virus (HBV) positivity

- Hepatitis C virus (HCV) positivity in presence of high level of virus replication and
Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > x 2.5 ULN

- Central nervous system (CNS) involvement by lymphoma

- Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

- Any other co-existing medical or psychological condition that would preclude
participation in the study or compromise ability to give informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Assess the efficacy

Outcome Description:

Evaluate the efficacy in term of Overall Response Rate (Complete Response + Partial Response) and Tumour Control Rate (Complete Response + Partial Response + Stable Disease)

Outcome Time Frame:

Two weeks after the completion of Rituximab + Lenalidomide

Safety Issue:


Principal Investigator

Stefano Sacchi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gruppo Italiano Studi Linfomi


Italy: Ethics Committee

Study ID:




Start Date:

April 2009

Completion Date:

October 2014

Related Keywords:

  • Indolent Non Hodgkin Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin