KTE-C19 for Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas MD Anderson Cancer Center, Houston, TX
Refractory Diffuse Large B Cell Lymphoma (DLBCL)+3 More
KTE-C19 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a combination of a drug and a light therapy can be safe and effective for people with lymphoma.

See full description

Eligible Conditions

  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Study Objectives

This trial is evaluating whether KTE-C19 will improve 2 primary outcomes and 17 secondary outcomes in patients with Refractory Diffuse Large B Cell Lymphoma (DLBCL). Measurement will happen over the course of Baseline up to 21 days.

Day 94
Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood
Phase 1 and 2: Peak Serum Levels of Ferritin in Blood
Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood
Day 21
Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Year 5
Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies
Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies
Day 1
Phase 1 and 2: Atezolizumab Levels in Blood
Year 5
Phase 1 and 2: Percentage of Participants Experiencing Adverse Events (AEs)
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values
Year 5
Phase 1 and 2: Objective Response Rate (ORR)
Year 5
Phase 1 and 2: Progression-Free Survival (PFS)
Year 5
Phase 1 and 2: Overall Survival (OS)
Year 5
Phase 1 and 2: Duration of Response (DOR)
Month 6
Phase 1 and 2: Complete Response Rate (CRR)
Month 24
Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood

Trial Safety

Safety Progress

1 of 3

Other trials for Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Trial Design

1 Treatment Group

KTE-C19 + ATZ
1 of 1
Experimental Treatment

This trial requires 37 total participants across 1 different treatment group

This trial involves a single treatment. KTE-C19 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

KTE-C19 + ATZParticipants will receive conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days. Treatment with ATZ will begin 21 days following KTE-C19 (Phase 1 Cohort 1), 14 days following KTE-C19 (Phase 1 Cohort 2), and 1 day following KTE-C19 (Phase 1, Cohort 3 & Phase 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of first kte-c19 infusion to the date of death regardless of cause (up to approximately 2.5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the date of first kte-c19 infusion to the date of death regardless of cause (up to approximately 2.5 years) for reporting.

Closest Location

University of Texas MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed DLBCL
Stable disease (duration of stable disease must be less than or equal to 6 months) or progressive disease as best response to most recent chemotherapy containing regimen
Disease progression or recurrence less than or equal to 12 months of prior autologous stem cell transplantation (SCT)
anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative;
an anthracycline containing chemotherapy regimen
At least one measurable lesion per revised International Working Group (IWG) Response Criteria
Age 18 years or older
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function
All individuals or legally appointed representatives/caregivers, must personally sign and date the institutional review board (IRB)/independent ethics committee (IEC) approved consent form before initiating any study specific procedures or activities.

Patient Q&A Section

Can lymphoma, large b-cell, diffuse be cured?

"Until now, no reliable cure has been found for large B-cell lymphoma. However, the number of patients in the various groups and their overall survival rate are better than the ones reported for non-Hodgkin's lymphoma. Also, survival rates from 1.45 years ago are higher than today." - Anonymous Online Contributor

Unverified Answer

What causes lymphoma, large b-cell, diffuse?

"Patients with primary non-Hodgkin's lymphoma and a history of previous Epstein-Barr virus serologic reactivity of lymphocytes have an increased risk of development of large cell lymphoma. Further studies are warranted to determine the relation between Epstein-Barr virus and large cell lymphoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, large b-cell, diffuse?

"Lymphoma is often treated with conventional chemotherapy followed by curative surgery, rituximab/RFTX in high-grade or rituximab in low-grade follicular, small lymphocytic, or [mantle cell lymphoma](https://www.withpower.com/clinical-trials/mantle-cell-lymphoma)s, alkylating chemotherapy for non-Hodgkin's lymphoma (NHL), R-CHOP for chemoresistant diffuse large B cell lymphoma (DLBCL), rituximab for refractory follicular NHL, and allogeneic stem cell transplantation for severe disease." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma, large b-cell, diffuse a year in the United States?

"The incidence of lymphoma, large-b-cell, diffuse is relatively high. Thus, further studies are indicated to determine the impact of this cancer in the U.S. population." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, large b-cell, diffuse?

"Patients diagnosed with large B-cell lymphoma, diffuse are a heterogeneous group of patients with similar clinical presentations. The most relevant initial signs depend on the initial presentation of a large B-cell lymphoma, diffuse patient." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, large b-cell, diffuse?

"Lymphoma, large-cell, large-b-cell, diffuse is a cancer that involves one or more lymph nodes and usually involves the peripheral or central areas of the body, such as the arms or legs. It is most common in individuals 45 years of age and older. It may be found in children, but is much less frequent in that age group. People usually present with symptoms of a mass or swelling." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma, large b-cell, diffuse?

"This article has identified key factors for clinical trial enrollment. Patients must have a life expectancy of at least another year and a substantial probability of relapse, but there is a broad range of acceptable candidates." - Anonymous Online Contributor

Unverified Answer

Does lymphoma, large b-cell, diffuse run in families?

"Patients with lymphoma, large B-cell diffuse have a slightly higher risk of lymphoma, large B-cell non-deletion but this trend is no longer statistically significant after a adjustment for clinical information." - Anonymous Online Contributor

Unverified Answer

Is kte-c19 typically used in combination with any other treatments?

"Findings from a recent study indicate that K19 is used in combination with cytotoxic chemotherapy in more than 90% of patients with mantle cell lymphoma to improve overall survival. Therefore, K19 is currently used in combination with conventional chemotherapy in mantle cell lymphoma." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lymphoma, large b-cell, diffuse?

"There has been significant advancement in treating HL, Large B-Cell NHD and it is reasonable that this advancement will continue the future. The treatment of HL and other B-cell lymphomas should be customized for each individual depending on their staging and characteristics that are known to affect outcome, which includes age: age is one that many doctors and families wish to consideration." - Anonymous Online Contributor

Unverified Answer

What does kte-c19 usually treat?

"Although the majority of cases received standard chemotherapy treatment, a substantial subset of patients was not adequately treated. Some patients were inappropriately treated, with a poor prognosis. The authors emphasize that complete blood counts, with a focus on white blood cells and red blood cells, for early diagnosis and treatment are essential in all patients treated by kte-ck19." - Anonymous Online Contributor

Unverified Answer

Is kte-c19 safe for people?

"Results from a recent paper reveals that kte-c19 is safe and effective for people with lymphoproliferative disorders and rheumatoid arthritis. It is also effective in people with other autoimmune diseases although there is a less pronounced effect in these patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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