stop_circleTerminated/Withdrawn

Lymphoma, Mantle-Cell

Phase IIa study of copanlisib in relapsed or refractory mantle cell lymphoma (MCL)

Trial purpose

The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
4
Trial Dates
August 2015 - August 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
New York, 10021, United States
Terminated
New York, 10029, United States
Terminated
Hackensack, 07601, United States
Terminated
Baltimore, 21287, United States
Terminated
Burlington, 05401, United States

Primary Outcome

  • Objective response rate (ORR)
    ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014.
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Complete response rate (CRR)
    Defined as the proportion of patients who have a best overall response of CR during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Disease control rate (DCR)
    Defined as the proportion of patients who have a best response of CR, PR, or stable disease (SD)
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival (PFS)
    Defined as the time (in days) from the date of first administration of study treatment to radiological disease progression or death from any cause (if death occurs before radiological progression is documented). PFS for patients without radiological progression or death at the time of analysis will be censored at the last date of evaluable tumor assessment. PFS for alive patients who have no tumor assessments after baseline will be censored at day 1.
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of response (DOR)
    Defined as the time (in days) from the date of first observed tumor response of CR or PR, whichever was noted earlier, to radiological disease progression or death from any cause (if death occurs before radiological progression is documented)
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival (OS)
    Defined as the time (in days) from the date of first administration of study treatment to death from any cause. The OS time for patients alive at the time of analysis will be censored at their last known alive date.
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
    date_rangeTime Frame:
    Approximately 7 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A single-arm, open-label Phase IIa study to evaluate the efficacy and safety of copanlisib monotherapy in patients with relapsed or refractory mantle cell lymphoma (MCL), who failed ibrutinib treatment or were unable to tolerate ibrutinib
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1