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CAR T-cell Therapy

2/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose expansion for Chronic Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Led By Jennifer N Brudno, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

"This trial aims to test a new treatment called anti-CD19 CAR T cell therapy for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Who is the study for?

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that hasn't responded to standard treatments. Participants must have a tumor sample available for CD19 testing, and their heart and overall health should be stable enough to undergo the procedures involved in the trial.Check my eligibility

What is being tested?

The study tests anti-CD19 CAR T cell therapy, where patients' own immune cells are modified to target cancer cells. It involves taking medication to reduce leukemia cells, extracting T cells from blood, genetically modifying them in a lab, and then infusing them back into the patient's bloodstream.See study design

What are the potential side effects?

Possible side effects include reactions related to infusion of modified T-cells such as fever, fatigue, headache; complications due to gene editing like abnormal immune responses; and effects from preparatory drugs including nausea and hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL.

Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL

Secondary outcome measures

Phase I+II: Assess complete response rate

Phase I+II: Assess duration of responses

Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose expansionExperimental Treatment4 Interventions

MTD dose or Optimal dose of Anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy

Group II: 1/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose escalationExperimental Treatment4 Interventions

Escalating dose of anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1080

Rituximab

1999

Completed Phase 4

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,680 Previous Clinical Trials

40,928,453 Total Patients Enrolled

Jennifer N Brudno, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction that excludes individuals above the age of 70 from participating in this clinical trial?

"This clinical investigation is seeking participants over 18 years old but under the age of 120."

Answered by AI

Are individuals currently able to participate in this research study?

"As per clinicaltrials.gov, recruitment for this research has concluded. The trial was posted on 4/18/2024 and last updated on 4/12/2024. Currently, there are an additional 1527 trials actively seeking participants."

Answered by AI

What are the anticipated results that researchers hope to achieve from conducting this medical study?

"The main goal of this research project is to investigate the response rate of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) in patients with advanced CLL. This assessment will be conducted from pre-leukapheresis rituximab throughout 5 years following CAR T infusion. Secondary objectives include evaluating the complete response rate after subsequent infusions, determining the duration of responses up to 5 years post-enrollment, and assessing the overall response rate for retreatment options involving rituximab, chemotherapy, and CAR T cells in eligible individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL)

2024. "Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06364423.

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