Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Patients who received previous treatment with JCAR015

No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.

JCAR015

Bristol-Myers Squibb

This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.

Genomic DNA prepared from peripheral blood mononuclear cells

Long-Term Follow-up Study for Patients Previously Treated With JCAR015

Long-Term Follow-up Protocol for Subjects Treated With JCAR015

Juno Therapeutics, a Subsidiary of Celgene

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Single dose of 1.0-3.0 mg/m\^2 IV cyclophosphamide, JCAR015 Dose 1 1x10\^6 Tcells/kg, JCAR015 Dose 2 3x10\^6 Tcells/kg

Jens Hasskarl, MD

This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part A of the study.

A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia

A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.

The primary efficacy endpoint (for Cohorts 1-4) is ORR as determined by an Independent Review Committee (IRC). The ORR is, defined as proportion of subjects with a best overall response of Complete response (CR) or Complete response with incomplete peripheral blood count recovery (CRi) from 28 days through 6 months after the final infusion of JCAR015 or the start of receiving another anti-cancer therapy whichever comes first.

Evaluate the proportion of subjects who achieve a MRD negative complete response (CR) and the duration of MRD negative status, if achieved, after JCAR015 administration.

Time from Minimal Residual Disease (MRD) response until MRD recurrence, morphologic relapse, or death

Relapse-free survival (RFS) is defined as the interval from the first documentation of complete response (CR) or Complete response with incomplete peripheral blood count recovery (CRi) to the earlier date of relapse or death due to any cause.

Is defined as the time from the date of the first JCAR015 infusion to death from any cause, relapse, or treatment failure, whichever occurs first

Is defined as the time from the date of the first JCAR015 infusion to date of death due to any reason

Percentage of subjects who achieve CR or CRi with an MRD-negative bone marrow, as assessed by IgH gene sequencing (or BCR-ABL qPCR or flow cytometry for Ph(+) ALL subjects)

Improvement of response in patients with MRD+ ALLL

Is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL. The first documentation of CR or CRi is defined as the latest of all dates of required measurements to establish the response. Duration of remission (DOR) will be evaluated based on the IRC evaluations for subjects who achieve a CR or CRi.

Time to reach maximum observed concentration in plasma

Area under the plasma concentration-time curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Long-Term Follow-up Study for Patients Previously Treated With JCAR015	NCT02813252	Acute Lymphobla...	JCAR015	18 Years -	Juno Therapeutics, a Subsidiary of Celgene
A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia	NCT02973191	Precursor Cell ...	JCAR015	18 Years -	Celgene

Spots Global Cancer Trial Database for jcar015

Every month we try and update this database with for jcar015 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.

Spots Global Cancer Trial Database for jcar015

Every month we try and update this database with for jcar015 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 jcar015 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.