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: MCL0208 - IIL-MCL0208
- Conditions
- Mantle cell lymphomaMedDRA version: 12.1Level: LLTClassification code 10061275Term: Mantle cell lymphoma
- Registration Number
- EUCTR2009-012807-25-PT
- Lead Sponsor
- IIL INTERGRUPPO ITALIANO LINFOMI ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
• Female subjects of childbearing potential must: 1) Understand that the study medication could have an expected teratogenic risk; 2) Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea; 3) Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks and every 4 weeks including 4
weeks after the end of study treatment, except in the case of confirmed tubal
sterilization.
• Male subjects must agree: 1) to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception; 2) Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 cardiac (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, not disease related, 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 seropositivity 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 vaccination are eligible. Patients who are
seronegative for HbsAg, but with HBcAb positive serology, will not be excluded from the study and be given Lamivudine (100 mg die) as prophylaxis starting one
week before chemotherapy. HbsAg and AST/ALT and HBVDNAifavailable, will be
monitored every three weeks. Lamivudine therapy should be continued for one year
after autotransplant. In the group of patients treated with Lenalidomide maintenance therapy after the first year of Lamivudine treatment, AST/ALT and HbsAg will be
monitored every four weeks during the second year if HBVDNA is not available.
12. Pregnant or lactating females.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method