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

This study has been terminated.
(The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))
Sponsor:
Information provided by (Responsible Party):
Pier Luigi Zinzani, University of Bologna
ClinicalTrials.gov Identifier:
NCT00968331
First received: August 28, 2009
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: Lenalidomide plus Rituximab
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • 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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REVLIMID plus RITUXIMAB

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
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. for at least 28days before starting study drug
    2. while participating in the study
    3. for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom,diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
  • Disease free of prior malignancies for equal or major 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968331

Locations
Italy
Institute Of Hematology "Seràgnoli"
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
  More Information

No publications provided

Responsible Party: Pier Luigi Zinzani, Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT00968331     History of Changes
Other Study ID Numbers: REVLIRIT01
Study First Received: August 28, 2009
Last Updated: August 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
relapsed and refractory DLBCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014