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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 : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Kite, A Gilead Company

November 6, 2015
November 10, 2015
July 27, 2018
November 2015
December 2019   (Final data collection date for primary outcome measure)
Phase 2: Overall Response Rate [ Time Frame: 12 months ]
• Objective response rate (CR+PR)
Phase 2: Overall Response Rate [ Time Frame: 12 months ]
• Objective response rate (complete response [CR] + partial response [PR]) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007) as determined by the study investigators
Complete list of historical versions of study NCT02601313 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: 12 Months ]
  • Best Objective Response [ Time Frame: 12 Months ]
  • Progression Free Survival [ Time Frame: 12 Months ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with Relapsed/Refractory MCL
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Relapsed/Refractory Mantle Cell Lymphoma
Biological: KTE-C19
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.
Intervention: Biological: KTE-C19
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
70
December 2033
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Medical Information 844-454-KITE medinfo@kitepharma.com
France,   Netherlands,   United States
 
 
NCT02601313
KTE-C19-102
Yes
Not Provided
Not Provided
Kite, A Gilead Company
Kite, A Gilead Company
Not Provided
Study Director: Arati Rao, M.D. Kite, A Gilead Company
Kite, A Gilead Company
July 2018

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