Mantle cell lymphoma MedDRA version: 14.1 Level: PT Classification code 10026805 Term: Mantle cell lymphoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10026804 Term: Mantle cell lymphoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10026803 Term: Mantle cell lymphom
Conditions
Sponsors
Nordic Lymphoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >65 years, or age = 65 years unable to tolerate high dose chemotherapy with autologous stem cell support 2. Histologically confirmed (according to the WHO classification) mantle cell lymphoma, stage II-IV, in need of treatment due to at least one of the following symptoms: a. Bulky disease: nodal or extranodal mass > 7cm in its greater diameter b. B symptoms c. Elevated serum LDH d. involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) e. symptomatic nodal or splenic enlargement f. compressive syndrome g. pleural/peritoneal effusion h. anemia (<12), thrombocytopenia (< 100) or neutropenia (<1.5) caused by bone marrow infiltration of lymphoma 3. No previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma. 4. WHO performance status 0 – 3 5. Written informed consent. 6. Female subjects of childbearing potential† must: a. Understand that the study medication is expected to have a teratogenic risk b. 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 amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception* i. Implant** ii. Levonorgestrel-releasing intrauterine system (IUS)** iii. Medroxyprogesterone acetate depot iv. Tubal sterilisation v. Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses vi. Ovulation inhibitory progesterone-only pills (i.e., desogestrel) * Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception. **prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia. a. Understand that even if she has amenorrhea, she must follow all the advice on effective contraception. b. She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy. c. Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment. d. Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. 7. Male subjects must a. Agree to use
Exclusion criteria
Exclusion criteria: 1. Impaired liver function (serum total bilirubin >34 mmol/L, except in case of haemolytic anemia or caused by lymphoma). 2. Absolute neutrophil count (ANC) 10 mg prednisolone/day. 9. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Phase I: Establishing maximally tolerable dose (MTD) of lenalidomide in combination with bendamustine and rituximab • Phase II: The primary efficacy variable is the evaluation of progression-free survival with lenalidomide, bendamustine and rituximab as frontline therapy in mantle cell lymphoma patients ;Secondary Objective: • Overall response rate with and without PET • Complete remission rate with and without PET • Health-related quality of life • Molecular remission rate by PCR • Overall survival • Safety • Evaluation of biomarkers for efficacy ;Primary end point(s): • Phase I: Establishing maximally tolerable dose (MTD) of lenalidomide in combination with bendamustine and rituximab • Phase II: The primary efficacy variable is the evaluation of progression-free survival with lenalidomide, bendamustine and rituximab as frontline therapy in mantle cell lymphoma patients | — |
Countries
Denmark, Finland, Sweden
Outcome results
None listed