Study of Lenalidomide(Revlimid) Plus Rituximab (Revlirit Regimen) in Elderly Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

NCT00968331 | Terminated Phase 2

• 1 other identifier: REVLIRIT01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles. After this induction phase, the CR, PR and SD will continue Lenalidomide with the same schedule for other 8 months.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

relapsed and refractory DLBCL

Outcome Measures

Primary Outcomes (1)

• To assess the antitumour activity of Lenalidomide plus Rituximab (REVLIRIT) as salvage treatment in elderly patients with relapsed or refractory DLBCL, in terms of Overall Response Rate (CR and PR)

  12 months

Secondary Outcomes (1)

• To assess the overall feasibility of the REVLIRIT regimen in terms of response To assess the duration of response, TTP and PFS, safety and tolerability of the REVLIRIT regimen in terms of AE and SAE frequency and severity

  12 months

Study Arms (1)

REVLIMID plus RITUXIMAB

EXPERIMENTAL

Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.

Drug: Lenalidomide plus Rituximab

Interventions

Lenalidomide plus Rituximab DRUG

Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.

REVLIMID plus RITUXIMAB

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Be = 65 years of age at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Patients with histological confirmation of DLBCL.
• Stage of disease at study entry may include stage II-III-IV according to Ann Arbor Classification
• Patients must have failed at least one prior treatments
• ECOG performance status of equal or less than 2 at study entry
• nLaboratory test results within these ranges:
• Absolute neutrophil count equal or major than 1.0 x 109/L
• Platelet count equal or major than 50 x 109/L
• Serum creatinine equal or less than 2.0 mg/dL
• Total bilirubin equal or less than 1.5 mg/dL
• AST (SGOT) and ALT (SGPT) equal or less than 2 x ULN or equal or less 5 x ULN if hepatic metastases are present
• Hemoglobin equal or major than 8 g/dl
• Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study:

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• 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.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type A, B or C.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Institute Of Hematology "Seràgnoli"

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: August 27, 2012

Record last verified: 2012-08

Locations

IT (1)