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Clinical Trials/EUCTR2014-003893-17-DE
EUCTR2014-003893-17-DE
Active, not recruiting
Phase 1

Combination of ibrutinib and bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma; a multicenter Phase I/II trial

SAKK, Swiss Group for Clinical Cancer Research0 sites49 target enrollmentJuly 24, 2017
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ConditionsHistologically confirmed mantle cell lymphoma in need of systemictreatmentRefractory or relapsed disease after pretreatment of non-bortezomib containingchemotherapy including high-dose therapyMedDRA version: 20.0Level: PTClassification code 10026801Term: Mantle cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10026800Term: Mantle cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsVelcadeImbruvica

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Histologically confirmed mantle cell lymphoma in need of systemictreatmentRefractory or relapsed disease after pretreatment of non-bortezomib containingchemotherapy including high-dose therapy
Sponsor
SAKK, Swiss Group for Clinical Cancer Research
Enrollment
49
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 24, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
SAKK, Swiss Group for Clinical Cancer Research

Eligibility Criteria

Inclusion Criteria

  • •6\.1\.1 Patient must give written informed consent before registration
  • •indicating that the patient understands the purpose of the procedures
  • •required for the trial and is willing to participate in the trial.
  • •6\.1\.2 Histologically confirmed mantle cell lymphoma with either
  • •overexpression of cyclin D1 protein or evidence of t(11;14\)(q13;q32\)
  • •assessed by cytogenetics, by fluorescence, in situ hybridization (FISH)
  • •or by polymerase chain reaction (PCR).
  • •6\.1\.3 Refractory or relapsed disease in need of systemic therapy after
  • •pretreatment with non\-bortezomib\-containing chemotherapy (including
  • •high\-dose therapy plus autologous stem cell support; induction and

Exclusion Criteria

  • •6\.2\.1 Prior therapy with ibrutinib or bortezomib
  • •6\.2\.2 Adverse event neuropathy of prior therapy grade \=2 (according
  • •to CTCAE criteria Version 4\.0\) at registration
  • •6\.2\.3 Previous malignancy within 5 years with the exception of
  • •adequately treated in situ cervical cancer or localized non\-melanoma
  • •skin cancer.
  • •6\.2\.4 Presence or history of CNS disease (either CNS lymphoma or
  • •lymphomatous meningeosis)
  • •6\.2\.5 Evidence of ongoing systemic infections of all kind
  • •6\.2\.6 Exclusion of the following prior treatments prior to trial

Outcomes

Primary Outcomes

Not specified

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