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Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients (MCL0208)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02354313
Recruitment Status : Unknown
Verified February 2018 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was:  Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : February 9, 2018
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).

Condition or disease Intervention/treatment Phase
MANTLE CELL LYMPHOMA Drug: Lenalidomide Phase 3

Detailed Description:
This is a Phase 3, multicenter, open-label, randomized, controlled study to determine the efficacy and safety of lenalidomide as maintenance therapy versus observation in patients with MCL in complete or partial remission after first line intensified and high-dose chemotherapy additioned with rituximab and followed by ASCT. This study will be conducted in three phases: a Screening Phase, a Treatment Phase and a Follow-up Phase

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized Study With Lenalidomide Maintenance vs Observation After Induction Regimen Containing Rituximab Followed by High Dose Chemotherapy and ASCT as First Line Treatment in Adult Patients With Advanced Mantle Cell Lymphoma
Actual Study Start Date : May 2010
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Lenalidomide
lenalidomide 10-15 mg once daily on days 1-21, every 28 day, for two years
Drug: Lenalidomide

Treatment Phase: consisting in an induction phase (3 cycles of RCHOP, given every 21 days); consolidation phase: (high-dose cyclophosphamide (CTX), 2 cycles of high dose Ara-C, BEAM and ASCT).

Randomization and maintenance phase: Patients who have achieved complete or partial response will be randomized between maintenance with lenalidomide or observation.

Other Name: Revlimid

No Intervention: Observation
no therapy is planned but only observation

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 30 months from randomisation ]
    PFS will be defined as the time between the date of randomization and the date of disease progression, relapse or death from any cause.therapy to prolong progression-free survival (PFS) after completion of first-line high-dose chemotherapy additioned with rituximab and followed by ASCT in adult patients with MCL who have achieved complete response (CR) or partial response (PR). PFS is defined according to Cheson et al (JCO, 2007) as the time from randomisation until lymphoma progression or death as a result of any cause.

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 36 months from randomisation (42 months from accrual) ]
    OS will be defined as the time between the date of randomization and the date of death from any cause

  2. Progression Free Survival (PFS) [ Time Frame: 36 months from accrual ]
    PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.

  3. Disease-free survival (DFS) [ Time Frame: 30 months from randomisation (36 months from accrual) ]
    DFS will be defined in CR patients as the time between the date of randomization and the date of relapse or death as a result of lymphoma or acute toxicity of treatment according to the Cheson 2007

  4. Event-free survival (EFS) [ Time Frame: 30 months from randomisation (36 months from accrual) ]
    EFS will be defined in CR patients as the time between the date of randomization and the date of failure of treatment or death as a result of any cause according to the Cheson 2007

  5. Complete Response (CR) Rate [ Time Frame: up to 3 months from accrual ]
    Proportion of CR according to the Cheson 2007 response criteria

  6. Overall Response Rate (ORR) [ Time Frame: up to 3 months from accrual ]
    ORR is defined as Complete Response (CR) or Partial Response (PR) according to the Cheson 2007 response criteria

  7. Incidence of grade 3 or higher Toxicity measured by CTCAE v.4 at any time during therapy and follow-up. [ Time Frame: 30 months from accrual ]
    Toxicity amount of grade 3 or more as CTCAE

  8. Quality of life [ Time Frame: baseline, 6-12-18-24 months from randomisation ]
    EORTC QLQC30 questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria.

  1. Any male or female adult with newly diagnosed mantle cell lymphoma according to the WHO criteria.
  2. Biopsy-proven mantle cell non-Hodgkin's lymphoma, including evidence of cyclin D1 overexpression or the translocation t(11;14)(q13;q32) by FISH or RT-PCR. In subjects whose tumors are negative for the cyclin D1, evidence of overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable.
  3. Age ≥18 years and < 60 with ECOG performance status 0-3, or an age from 60 to 65 years with an ECOG performance status 0-2, except when PS impairment is related to NHL.
  4. Advanced stage (Stage III and IV according to Ann Arbor and stage II with bulky disease defined as a mass ≥ 5 cm or B symptoms).
  5. Measurable disease (two diameters) in at least one site. Osteoblastic bone lesions, ascites and pleural effusion are not considered measurable disease.
  6. Written informed consent prior to any study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  7. Be willing and able to comply with the protocol for the duration of the study.
  8. Females of childbearing potential (FCBP) must: have two negative medically supervised pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. The following are effective methods of contraception

    • Implant
    • Levonorgestrel-releasing intrauterine system (IUS)
    • Medroxyprogesterone acetate depot
    • Tubal sterilisation
    • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
    • Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
  9. Male patients must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
  10. All patients must have an understanding that the study drug could have a potential teratogenic risk. They must agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. They must to agree not to share study medication with another person. They must be counseled about pregnancy precautions and risks of fetal exposure.

Exclusion Criteria:

  1. Non-Hodgkin's lymphoma subtypes other than MCL
  2. Cytological variant with small cells with round nuclei mimicking CLL, which is frequently recognized in patients with a leukemic and splenomegaly presentation without or with minimal involvement of lymph nodes and has an indolent clinical course.
  3. History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) within the last 3 years.
  4. Major surgery, other than diagnostic surgery, within the last 4 weeks.
  5. Evidence of CNS involvement, patients with an history of uncontrolled seizures, central nervous system disorders or psychiatric disability considered by the Investigator to be clinically significant and adversely affecting compliance to study drugs. If clinically indicated, lumbar puncture, and MRI should be performed during the screening process.
  6. Clinically significant cardiac disease (VEF <45%) (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) and marked impairment of pulmonary function (pulmonary diffusing capacity <50%).
  7. Unacceptable hematologic values in the week prior to the start of study: hemoglobin <9 g/dL, WBC <3x109/L, platelets <60x109/L, absolute neutrophil count (ANC)<1.5x109/L (unless cytopenia is secondary to bone marrow involvement or autoimmune cytopenia related to lymphoma).
  8. Abnormal liver function tests, within one week prior to study start above any of the values listed: serum bilirubin > 2 mg/dL, ALT or AST >3 times the upper normal value; alkaline phosphatase>2.5 times the upper normal value (unless these abnormalities are due to liver involvement of lymphoma).
  9. Abnormal renal function (serum creatinine >2.0 mg/dL), unless it is disease related
  10. Patients with active opportunistic infections.
  11. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Patients with HBcAb serology, will not be excluded from the study and be given lamivudine as prophylaxis starting one week before chemotherapy. HbsAg and AST/ALT ifHBV DNA is not available, will be monitored every three weeks. If HBV DNA is available, it will be monitored along with HBsAg
  12. Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02354313

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Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
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Study Director: Sergio Cortelazzo, MD Humanitas Gavazzeni - Bergamo, Lombardia
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Fondazione Italiana Linfomi ONLUS Identifier: NCT02354313    
Other Study ID Numbers: IIL-MCL0208
2009-012807-25 ( EudraCT Number )
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Keywords provided by Fondazione Italiana Linfomi ONLUS:
Lenalidomide (Len)
High dose chemotherapy
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents