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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

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 Drug: Cyclophosphamide Drug: Fludarabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : March 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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
Drug: Cyclophosphamide
Administered intravenously

Drug: Fludarabine
Administered intravenously




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. Incidence of anti-KTE-C19 antibodies [ Time Frame: Up to 15 years ]
  8. Levels of anti-CD19 CAR T cells in blood [ Time Frame: Up to 15 years ]
  9. Levels of cytokines in serum [ Time Frame: Up to 15 years ]
  10. 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.



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

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.


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 32 Study Locations
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
Study Director: Kite Study Director Kite, A Gilead Company

Publications:
Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT02601313     History of Changes
Other Study ID Numbers: KTE-C19-102
2015-005008-27 ( EudraCT Number )
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites