Non Hodgkin Lymphoma Clinical Trial

Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients

Summary

The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). For pediatric patients who have r/r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.

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Full Description

This study is part of an agreed Pediatric Investigation Plan (PIP). The single-arm study design includes r/r B-cell NHL subject population with poor prognosis, lack of approved effective therapies in this setting. Subject population will include aggressive subtypes of B-cell NHL and will be allowed to receive "bridging therapy" of investigator's choice After assessment of eligibility, subjects qualifying for the study will be enrolled and are allowed to start lymphodepleting chemotherapy as recommended in protocol after which a single dose of tisagenlecleucel product will be infused. The efficacy of tisagenlecleucel will be evaluated through the primary endpoint of Overall Response Rate (ORR) which includes complete response (CR) and partial response (PR) as determined by local assessment. Safety assessments will be conducted through the study completion.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed pediatric mature B-cell non-Hodgkin lymphoma (B-cell NHL) including the following subtypes; Burkitt lymphoma/ Burkitt leukemia (BL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), gray zone lymphoma (GZL), and follicular lymphoma (FL) Note: Patients with B-cell NHL associated with Nijmegen breakage syndrome will be allowed.
Patients <25 years of age and weighing at least 6 kg the time screening
Patients who have relapsed after one or more prior therapies (can include allogeneic and autologous hematopoietic stem cell transplant) or are primary refractory (have not achieved a CR or PR after the first line of therapy)
Measurable disease by radiological criteria in all patients at the time of screening. Patients with Burkitt leukemia who don't meet radiological criteria must have bone marrow involvement of >25% by local assessment of bone marrow aspirate and/or biopsy.
Karnofsky (age ≥16 years) or Lansky (age <16 years) performance status ≥60.

Adequate bone marrow reserve without transfusions (transfusion >2 weeks prior to laboratory assessment is allowed) defined as:

Absolute neutrophil count (ANC) >1000/mm3
Platelets ≥50000//mm3
Hemoglobin ≥8.0 g/dl

Adequate organ function defined as:

a serum creatinine (sCR) based on gender/age as follows: Maximum Serum Creatinine (mg/dL) Age Male Female

1 to <2 years 0.6 2 to <6 0.8 6 <10 1.0 10 <13 1.2 13 <16 1.5 1.4

≥16 years 1.7 1.4

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 times the upper limit of normal (ULN) for age
Total bilirubin <2 mgdL (for Gilbert's Syndrome patients total bilirubin <4dL)
Adequate pulmonary function

i. Oxygen saturation of >91% on room air ii. No or mild dyspnea (≤Grade 1)

Must have a leukapheresis material of non-mobilized cells accepted for manufacturing.

Exclusion Criteria:

Prior gene therapy or engineered T cell therapy.
Prior treatment with any anti-CD19 therapy.
Allogeneic hematopoietic stem cell transplant (HSCT) <3 months prior to screening and ≤4 infusion.
Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) in patients who received prior allogeneic HSCT.
Prior diagnosis of malignancy other than study indication, and not disease free for 5 years.
Clinically significant active infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA, etc.)
Presence of active hepatitis B or C as indicated by serology.
Human Immunodeficiency Virus (HIV) positive test.
Active neurological autoimmune or inflammatory disorders not related to B cell NHL (eg: Guillain-Barre syndrome, Amyotrophic Lateral Sclerosis)
Active central nervous system (CNS) involvement by malignancy.
Patients with B-cell NHL in the context of post-transplant lymphoproliferative disorders (PTLD) associated lymphomas.

Other protocol-defined inclusion/exclusion criteria may apply.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT03610724

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 26 Locations for this study

See Locations Near You

Childrens Hospital Los Angeles
Los Angeles California, 90027, United States
UCSF Medical Center
San Francisco California, 94143, United States
Johns Hopkins Oncology Center ORA
Baltimore Maryland, 21231, United States
Dana Farber Cancer Institute Dept.of DFCI
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center MSKCC (8)
New York New York, 10065, United States
Cincinnati Children s Hospital Medical Center
Cincinnati Ohio, 45229, United States
The Childrens Hospital of Philadelphia Drug Shipment
Philadelphia Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75235, United States
Novartis Investigative Site
Randwick New South Wales, 2031, Australia
Novartis Investigative Site
Parkville Victoria, 3052, Australia
Novartis Investigative Site
Wien , A 109, Austria
Novartis Investigative Site
Toronto Ontario, M5G 1, Canada
Novartis Investigative Site
Copenhagen , 2100, Denmark
Novartis Investigative Site
Helsinki , 00029, Finland
Novartis Investigative Site
Paris Cedex , 75019, France
Novartis Investigative Site
Villejuif Cedex , 94800, France
Novartis Investigative Site
Muenster , 48149, Germany
Novartis Investigative Site
Monza MB, 20900, Italy
Novartis Investigative Site
Roma RM, 00165, Italy
Kyoto University Hospital
Sakyo Ku Kyoto, 606 8, Japan
Novartis Investigative Site
Setagaya-ku Tokyo, 157-8, Japan
Prinses Maxima Centrum voor Kinderoncologie
Utrecht CS, 3584, Netherlands
Novartis Investigative Site
Oslo , 0424, Norway
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Madrid , 28046, Spain
Novartis Investigative Site
London , WC1N , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT03610724

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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