enalidomide, bendamustine and rituximab as first-line therapy for patients >65 years with mantle cell lymphoma - LENA-BERIT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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 condoms throughout study drug the

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) <1.0x 109, unless caused by bone marrow infiltration by lymphoma.
3. Platelet count <60 x 109, unless caused by bone marrow infiltration by lymphoma.
4. Creatinine clearance below 50 ml/min (Cockcroft-Gault)
5. Known HIV positivity.
6. Known seropositivity for HCV, HBsAg, anti-HBc, or other active infection uncontrolled by treatment.
7. Psychiatric illness or condition which could interfere with the subjects’ ability to understand the requirements of the study.
8. Requirement of corticosteroid therapy at a dose >10 mg prednisolone/day.
9. 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

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