Lenalidomide Plus Rituximab (R) in Non Follicular NHL

Sponsor

Gruppo Italiano Studio Linfomi (Other)

Overall Status

Unknown status

CT.gov ID

NCT01830478

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether lenalidomide in association with rituximab is effective in the treatment of patients with indolent non follicular NHL relapsed after

=2, but less than 4 prior lines of (immuno)chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Indolent Non Hodgkin Lymphoma	Drug: Lenalidomide Drug: Rituximab	Phase 2

Detailed Description

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patients will be evaluated for tumor response (complete assessment); the patients with Progressive Disease (PD) will be withdrawn of the study.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and Partial Response (PR), and with a stable disease will undergo the follow up phase, while patients with PD will be withdrawn of the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lenalidomide and Rituximab Lenalidomide 20 mg once daily on days 1-21 of 28 days cycle for up to 6 courses and Rituximab 375 mg/m2 at day 14 of every course.	Drug: Lenalidomide Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles Other Names: Revlimid Drug: Rituximab Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles Other Names: Mabthera

Arm

Intervention/Treatment

Experimental: Lenalidomide and Rituximab

Lenalidomide 20 mg once daily on days 1-21 of 28 days cycle for up to 6 courses and Rituximab 375 mg/m2 at day 14 of every course.

Drug: Lenalidomide

Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles

Other Names:

Revlimid

Drug: Rituximab

Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles

Other Names:

Mabthera

Outcome Measures

Primary Outcome Measures

Assess the efficacy [Two weeks after the completion of Rituximab + Lenalidomide]
Evaluate the efficacy in term of Overall Response Rate (Complete Response + Partial Response) and Tumour Control Rate (Complete Response + Partial Response + Stable Disease)

Secondary Outcome Measures

Assess the safety [From start of treatment for all follow up period (18 months)]
The safety will be evaluated on the basis of recorded toxicities graded on a scale of 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 histotype
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Oncologico Modenese	Modena	MO	Italy	41124

Sponsors and Collaborators

Gruppo Italiano Studio Linfomi

Investigators

Principal Investigator: Stefano Sacchi, MD, Gruppo Italiano Studi Linfomi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gruppo Italiano Studio Linfomi

ClinicalTrials.gov Identifier:

NCT01830478

Other Study ID Numbers:

INFL08

First Posted:

Apr 12, 2013

Last Update Posted:

Apr 12, 2013

Last Verified:

Apr 1, 2013

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Rituximab

Lenalidomide

Study Results

No Results Posted as of Apr 12, 2013