Venetoclax, lenalidomide and rituximab in patients with relapsed/refractory mantle cell lymphoma.

Phase 1

Active, not recruiting

• Conditions: Relapsed/refractory mantle cell lymphoma.; MedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001060-38-NO
• Lead Sponsor: ordic Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-08
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

1.Age >18 years
2.Histologically confirmed (according to the WHO 2016 classification) mantle cell lymphoma stage I-IV
3.
a.Who have received at least 1 prior rituximab-containing chemotherapy regimen, with documented relapse or disease progression following
the last anti-MCL treatment

OR

b.Are not considered to be candidates for chemotherapy due to frailty or comorbidity
4.At least 1 measurable site of disease (>1.5 cm long axis)
5.WHO performance status 0 – 3
6.Written informed consent.
7.Female subjects of childbearing potential must:
a.Understand that the study medication is expected to be teratogenic
b.Agree to use, and be able to comply with, highly 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.
c.Highly effective contraception include:
d.Combined (estrogen and progesteroncontaining) hormonalcontraception associated with inhibition of ovulation:
i.oral
ii.Intravaginal
iii.Transdermal
b.Progesterone-only hormonal contraception associated with inhibition of ovulation:
i.oral
ii.Injectable
iii.Implantable
c.Intrauterine device (IUD)
d.Intrauterine hormone-releasing system (IUS)
e.Bilateral tubal occlusion
f.Vasectomized partner
g.Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The
reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject).
8.Male subjects must
a.Agree 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.
b.Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
9.All subjects must
a.Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
b.Agree not to share study medication with another person and to return all unused study drug to the investigator

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion Criteria

1.
a.Chemotherapy or radiotherapy within 3 weeks
b.Therapeutic antibodies or BTK inhibitors within 4 weeks
c.Radioimmunotherapy within 10 weeks
d.Major surgery within 4 weeks of inclusion in this trial.
2.Previous treatment with venetoclax
3.Impaired liver function: AST and ALT >3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin > 1.5 × ULN. Subjects with
Gilbert's Syndrome may have a bilirubin > 1.5 × ULN, per discussion between the investigator and medical monitor. Elevated Bilirubin due
to haemolytic anemia or caused by lymphoma, is not an exclusion criterion.
4.Absolute neutrophil count (ANC) <1.0x 109, unless caused by bone marrow infiltration by lymphoma.
5.Platelet count <60 x 109, unless caused by bone marrow infiltration by lymphoma.
6.Creatinine clearance below 50 ml/min (Cockcroft-Gault)
7.Known CNS lymphoma.
8.Other active malignancy.
9.Psychiatric illness or condition which could interfere with the subjects’ ability to understand the requirements of the study.
10.Requirement of corticosteroid therapy at a dose >10 mg prednisolone/day.
11.Hypersensitivity to venetoclax, lenalidomide or rituximab, or HACA against rituximab.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified