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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00968331
• Date of registration: 28/08/2009
• Primary sponsor: University of Bologna
• Public title: Study of Lenalidomide(Revlimid) Plus Rituximab (Revlirit Regimen) in Elderly Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
• Date of first enrolment: March 2009
• Target sample size: 25
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00968331
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Key inclusion & exclusion 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.



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diffuse Large B-cell Lymphoma

Intervention(s)

Drug: Lenalidomide plus Rituximab

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

REVLIRIT01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors