Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z. Such cells will be administered in a single infusion intravenously at a total ARI-0001 cell dose of 0.5-10 x 106 / kg body weight.

After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.

Adult differentiated autologous T-cells

Julio Delgado González, PhD MD

To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity \[A3B1\] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.

Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy

Pilot Study on the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity Conjugated With the Co-stimulatory Regions 4-1BB and CD3z in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy

Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event.

number of adverse events grade III-IV using CTC (common toxicity criteria)

Defined differently for each disease:

* On chronic lymphoid and acute lymphocytic leukemia, the usual criteria NCCN and IWCLL will be used.
* On non-Hodgkin's lymphoma, the Lugano criteria will be used-
* On patients with leukemia will be quantified the persistence of minimal residual disease, in bone marrow and peripheral blood, using multiparametric cytometry and new generation sequencing techniques.

Time lag between infusion of ARI-0001 and the progression of disease or death. Patients alive and in complete remission will be censored at the last follow-up

Time lag between the infusion of ARI-0001 and the death of the patient from any cause. Living patients will be censored at the the last follow-up.

Determined monthly during the first 6 months by flow cytometry and quantitative transgene PCR.

Determined quarterly from month 6 until the 2 years after infusion, by flow cytometry and quantitative transgene PCR.

Evaluated by a questionnaire completed by patients or their legal guardians

defined as number of adverse events of any type occurring throughout the study using the common toxicity criteria

Instituto de Salud Carlos III

Sara V. Latorre

Clinical Research Manager

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Tisagenlecleucel

Antineoplastic Agents, Immunological

CTL019

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs

Novartis Pharmaceuticals

Sajad Khazal

Emmanuel Katsanis

Dana Salzberg

Leslie Popplewell

Michael Pulsipher

James Chng

Josh Sasine

Liora Schultz

Dimitrios Tzachanis

Deborah Schiff

Michelle Hermiston

Charalambos Andreadis

Christopher Seet

Gauri Sunkersett

Pamela Allen

Jonathon Cohen

Amelia Langston

Muna Qayed

Reem Karmali

Peter Riedell

John Cunningham

Rayne Rouce

Aaron Rapoport

Nancy Hardy

Saurabh Dahiya

Patrick Brown

Andreas Klein

Matthew Frigault

Steven Margossian

Caron Jacobson

Gregory Yanik

Mark Vander Lugt

Monalisa Ghosh

Abinav Deol

Julio Chavez

Edward Peres

Heather Stefanski

Fiona He

Mohamed Kharfan Dabaja

Armin Ghobadi

Michele Donato

Andrew Evens

Mathew Barth

Philip McCarthy

Lia Palomba

Craig Sauter

Prakash Satwani

Michael Scordo

Natalie Sophia Grover

Jeffrey Huo

Christine Phillips

Kirsten Boughan

Rajinder Bajwa

Jonathan Brammer

Samantha Jaglowski

Theodore Laetsch

Brandon Hayes-Lattin Hayes-Lattin

Stephan Grupp

Stephen Schuster

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

CTL019 Out of Specification MAP for ALL or DLBCL Patients

Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to Provide Access for Patients With Out of Specification Leukapheresis Product and/or Out of Specification Manufactured Tisagenlecleucel (CTL019; Kymriah®)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy	NCT03144583	Leukemia Lymphoma	Adult different...	2 Years - 80 Years	Institut d'Investigacions Biomèdiques August Pi i Sunyer
CTL019 Out of Specification MAP for ALL or DLBCL Patients	NCT03601442	Acute Lymphobla... Diffuse Large B...	CTL019	1 Day - 25 Years	Novartis
CTL019 Out of Specification MAP for ALL or DLBCL Patients	NCT03601442	Acute Lymphobla... Diffuse Large B...	CTL019	1 Day - 25 Years	Novartis

Spots Global Cancer Trial Database for cart19

Every month we try and update this database with for cart19 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for cart19

Every month we try and update this database with for cart19 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cart19 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.