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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 : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Kite, A Gilead Company

November 6, 2015
November 10, 2015
October 4, 2018
November 2015
June 2019   (Final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Up to 24 months ]
Objective response rate (ORR) is defined as the incidence of a CR or a PR per the Lugano Classification (Cheson et al, 2014), as determined by the Independent Radiology Review Committee (IRRC).
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: Up to 24 months ]
    Duration of response (DOR) is defined as the time from their first objective response to disease progression or death.
  • Best Objective Response [ Time Frame: Up to 24 months ]
    Best objective response is defined as the incidence of CR, PR, SD, progressive disease, or unevaluable as best response to treatment
  • Progression Free Survival [ Time Frame: Up to 24 months ]
    Progression free survival (PFS) is defined as the time from the anti‑CD19 CAR T cells infusion date to the date of disease progression or death from any cause
  • Objective Response Rate [ Time Frame: Up to 24 months ]
    Objective response rate (ORR) is defined as the incidence of either a CR or PR determined by investigator
  • Overall Surival [ Time Frame: Up to 15 years ]
    Percentage of participants experiencing treatment-emergent adverse events; Percentage of participants who had clinically significant changes in laboratory values.
  • Incidence of adverse events (AEs) and clinically significant changes in laboratory values [ Time Frame: Up to 15 years ]
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events; Percentage of participants who had clinically significant changes in laboratory values.
  • Incidence of anti-KTE-C19 antibodies [ Time Frame: Up to 15 years ]
  • Levels of anti-CD19 CAR T cells in blood [ Time Frame: Up to 15 years ]
  • Levels of cytokines in serum [ Time Frame: Up to 15 years ]
  • Changes over time in the EQ-5D scale score and visual analogue scale score [ Time Frame: Up to 6 months ]
    The EQ-5D consists of a 5-dimension descriptive system, including questions on mobility, self-care, usual activities, pain/comfort, and anxiety/depression, and a visual analogue scale (VAS) that allows the respondent to record health on a vertical scale (eg, best health to worst health), thus allowing a quantitative measure of health outcome.
  • Duration of Response [ Time Frame: 12 Months ]
  • Best Objective Response [ Time Frame: 12 Months ]
  • Progression Free Survival [ Time Frame: 12 Months ]
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
  • Drug: Cyclophosphamide
    Administered intravenously
  • Drug: Fludarabine
    Administered intravenously
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.
Interventions:
  • Biological: KTE-C19
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Español de Médula Ósea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
70
March 2034
June 2019   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

Up to 5 prior regimens for mantle cell lymphoma (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 echocardiogram (ECHO), and no clinically significant electrocardiogram (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 central nervous system (CNS) involvement
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
2015-005008-27 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Kite, A Gilead Company
Kite, A Gilead Company
Not Provided
Study Director: Kite Study Director Kite, A Gilead Company
Kite, A Gilead Company
October 2018

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