Combination of ibrutinib and bortezomib and maintenance with ibrutinib in patients with mantle cell lymphoma

Phase 1

• Conditions: Mantle ell lymphoma; MedDRA version: 20.0Level: LLTClassification code 10026806Term: Mantle zone lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003893-17-IT
• Lead Sponsor: SAKK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-15
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

-Mantle cell lymphoma with either overexpression of cyclin D1 protein or evidence of t
-Refractory or relapsed LCM after pretreatment with nonbortezomib-containing chemotherapy
-At least one measurable lesion =11 mm (greatest transverse diameter) measured with CT scan or MRI
-Adequate hematological values, hepatic and renal function
-Effective method of birth control in women of childbearing potential and men who are sexually active
-Negative pregnancy test in women of childbearing potential; breastfeeding women are ineligible for this trial
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Prior therapy with ibrutinib or bortezomib
-Actual or prior presence of the disease in the CNS
-Exclusion of the following prior treatments prior to trial registration
o major surgery within 4 weeks
o concurrent treatment with other experimental drugs or treatment in a clinical trial within
30 days.
o treatment with chemotherapy and radiotherapy within 3 weeks
o vaccinated with live, attenuated vaccines within 4 weeks
-History of stroke or intracranial hemorrhage within 6 months prior to trial registration
-Requires anticoagulation with warfarin or equivalent vitamin K antagonists
-Requires treatment with strong or moderate CYP3A inhibitors
-Prior allogeneic bone marrow or solid organ transplantation

Study & Design

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