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A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

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ClinicalTrials.gov Identifier: NCT02601313
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kite, A Gilead Company

Brief Summary:
Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with Relapsed/Refractory MCL

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Mantle Cell Lymphoma Biological: KTE-C19 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
Study Start Date : November 2015
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: KTE-C19
Experimental: Single Arm. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion CAR transduced autologous T cells administered intravenously.
Biological: KTE-C19



Primary Outcome Measures :
  1. Phase 2: Overall Response Rate [ Time Frame: 12 months ]
    • Objective response rate (CR+PR)


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 12 Months ]
  2. Best Objective Response [ Time Frame: 12 Months ]
  3. Progression Free Survival [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Up to 5 prior regimens for MCL. Prior therapy must have included:

  • Anthracycline or bendamustine-containing chemotherapy and
  • Anti-CD20 monoclonal antibody therapy and
  • Ibrutinib or acalabrutinib

At least 1 measurable lesion

Platelet count ≥ 75,000/uL

Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings

Baseline oxygen saturation >92% on room air.

Key Exclusion Criteria:

  • Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601313


Contacts
Contact: Medical Information 844-454-KITE medinfo@kitepharma.com

  Show 26 Study Locations
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
Study Director: Wayne Godfrey, M.D., M.S. Kite, A Gilead Company

Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT02601313     History of Changes
Other Study ID Numbers: KTE-C19-102
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin