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A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227251
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE August 28, 2014
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE November 2014
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
Objective Response [ Time Frame: one year ]
Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Official Title  ICMJE Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Brief Summary A multicenter, open-label Phase 2b study of selinexor (KPT-330) in patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit.
Detailed Description This is a multicenter, open-label Phase 2b study of the SINE compound, selinexor. A fixed 60 mg dose of selinexor is given orally to patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit. One hundred thirty patients with relapsed/refractory DLBCL who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred. Patients will be followed until disease progression and/or death.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE Drug: Selinexor
Fixed milligram dose of 60 mg selinexor orally twice weekly.
Other Name: KPT-330
Study Arms  ICMJE Experimental: Selinexor (KPT-330)
Fixed milligram dose of 60 mg selinexor orally, twice weekly on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (28 day) cycle (total of 8 doses per cycle).
Intervention: Drug: Selinexor
Publications * Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. doi: 10.1016/S2352-3026(20)30120-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 17, 2018)
129
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2014)
200
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Pathologically confirmed de novo DLBCL
  • Objective, documented evidence of disease progression on study entry
  • Have previously received at least 2 but no more than 5 previous systemic regimens for the treatment of DLBCL
  • Have measurable disease
  • For patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other patients, at least 14 weeks must have elapsed since their most recent systemic anti-DLBCL therapy

Exclusion Criteria:

  • DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (HL+NHL) or DLBCL transformed from diseases other than indolent NHL
  • Must not be eligible for high-dose therapy with autologous stem cell transplantation rescue
  • Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
  • Known central nervous system (CNS) lymphoma
  • Active Hepatitis B or C infection
  • Known human immunodeficiency virus (HIV) infection
  • Unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI function that could interfere with absorption of study treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Netherlands,   New Zealand,   Poland,   Serbia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02227251
Other Study ID Numbers  ICMJE KCP-330-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karyopharm Therapeutics Inc
Study Sponsor  ICMJE Karyopharm Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Kauffman, MD, PhD Karyopharm Therapeutics Inc
PRS Account Karyopharm Therapeutics Inc
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP