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(The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))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

August 28, 2009
August 24, 2012
March 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
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: Safe and useful ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00968331 on ClinicalTrials.gov Archive Site
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 ]
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: Quality and quantity of response ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Lenalidomide(Revlimid) Plus Rituximab (Revlirit Regimen) in Elderly Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Not Provided

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma
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.
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.

Intervention: Drug: Lenalidomide plus Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
December 2011
December 2009   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00968331
REVLIRIT01
Not Provided
Pier Luigi Zinzani, University of Bologna
University of Bologna
Not Provided
Not Provided
University of Bologna
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP