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CAR T-cell Therapy
Cellular Immunotherapy After Chemotherapy for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Tanya Siddiqi
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease stratum 2 (CLL/PLL/SLL): chronic lymphocytic leukemia (CLL), and B-cell prolymphocytic leukemia (PLL), and small lymphocytic lymphoma (SLL)
Karnofsky performance status (KPS) of >= 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of cellular immunotherapy following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia, or B-cell prolymphocytic leukemia that has come back.
Who is the study for?
This trial is for patients with certain types of blood cancers that have returned, including various non-Hodgkin lymphomas and chronic leukemias. Participants should have a life expectancy of at least 16 weeks, be able to use contraception, understand the study and consent to it, have adequate organ function (kidney, liver, heart), not be on immunosuppressants or other disqualifying treatments recently, and not need oxygen or intensive care support.Check my eligibility
What is being tested?
The trial tests a cellular immunotherapy where white blood cells are genetically modified to attack cancer following chemotherapy. It aims to determine the best dose and side effects of this treatment in patients whose disease has recurred after previous therapies.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's activation such as fever or fatigue; complications from cell infusion; possible damage to organs targeted by the engineered cells; and typical chemotherapy-related issues like nausea or low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have CLL, PLL, or SLL.
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I am able to care for myself but may not be able to do active work.
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My last chemotherapy dose was over a week ago.
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My diagnosis of B cell lymphoma has been confirmed to be recurring, worsening, or remaining.
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My diagnosis is a type of B-cell lymphoma.
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My kidney function, measured by creatinine clearance, is good.
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It has been over 2 weeks since my last dose of immunosuppressant medications.
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My platelet count is above 50,000 without needing transfusions or growth support for a week.
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I do not need medication to maintain my blood pressure and do not have heart rhythm problems.
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My kidney function is normal, with creatinine levels not doubled.
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My last strong chemotherapy was over 2 weeks ago.
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I have a frozen T cell product ready for infusion.
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I don't need extra oxygen and my oxygen levels are 90% or higher without help.
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Side effects from my previous treatments have mostly gone away or are permanent.
Select...
I do not have any ongoing infections that aren't under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity rate at the recommended phase II dose assessed using CTCAE v4.0
Toxicity profile of T-cell infusion as defined by all toxicities associated with T cells at the probably or definite levels
Secondary outcome measures
CD19 B cell aplasia/immunoglobulin G levels
Detection of transferred T cells in the circulation for at least 28 days by quantitative-polymerase chain reaction
Biopsy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (lymphodepletion, cellular immunotherapy)Experimental Treatment5 Interventions
LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and extent of disease comprising of cyclophosphamide, bendamustine hydrochloride, fludarabine phosphate, etoposide.
CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes IV over 10-15 minutes on day 0. Patients with relapsed, residual or progressive disease may receive an optional second infusion of autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes >= 28 days post T cell infusion.
Disease status: Patients with Chronic lymphocytic leukemia (CLL) and/or Prolymphocytic Leukemia (PLL).
Group II: Group I (lymphodepletion, cellular immunotherapy)Experimental Treatment5 Interventions
LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and extent of disease comprising of cyclophosphamide, bendamustine hydrochloride, fludarabine phosphate, etoposide.
CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes IV over 10-15 minutes on day 0. Patients with relapsed, residual or progressive disease may receive an optional second infusion of autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes >= 28 days post T cell infusion.
Disease status: Patients with Non-Hodgkin lymphoma (NHL).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Etoposide
2010
Completed Phase 3
~2440
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Bendamustine Hydrochloride
2011
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,423 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,630 Total Patients Enrolled
Tanya SiddiqiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of lymphoma or leukemia and may not have qualified for certain other treatments.I have CLL, PLL, or SLL.I am able to care for myself but may not be able to do active work.My last chemotherapy dose was over a week ago.Participants who have previously received a specific type of experimental treatment.I do not have any uncontrolled illnesses that would affect my study participation.I do not have active hepatitis B or C, HIV, or any signs of active infection.I have no other active cancer or any treated within the last 2 years and now in complete remission.You have evidence that the disease has come back, gotten worse, or still remains after previous treatment.Women who could become pregnant must have a negative pregnancy test.My kidney function, measured by creatinine clearance, is good.Your ALT and AST liver enzyme levels are not more than 2.5 times the normal limit at the testing center.Your heart's ejection fraction, measured by specific tests, is more than 45%.You have a normal level of a type of white blood cell called neutrophils.I rely on corticosteroids for my health condition.I understand the study's purpose, procedures, and the risks/benefits of participating.I am on medication to suppress my immune system due to an autoimmune disease.It has been over 2 weeks since my last dose of immunosuppressant medications.My platelet count is above 50,000 without needing transfusions or growth support for a week.My last cancer treatment was over 2 weeks ago.It has been at least 2 weeks since my last dose of an experimental drug.I do not need medication to maintain my blood pressure and do not have heart rhythm problems.My kidney function is normal, with creatinine levels not doubled.My last strong chemotherapy was over 2 weeks ago.I haven't taken any experimental drugs in the last 2 weeks.I have a frozen T cell product ready for infusion.I don't need extra oxygen and my oxygen levels are 90% or higher without help.I am not allergic or sensitive to specific cancer drugs like cyclophosphamide or tocilizumab.My diagnosis is a type of B-cell lymphoma.My diagnosis of B cell lymphoma has been confirmed to be recurring, worsening, or remaining.Side effects from my previous treatments have mostly gone away or are permanent.Your total bilirubin level must be less than or equal to 2.0 mg/dL.I agree to use birth control during and for six months after the study.I do not have any ongoing infections that aren't under control.Your bilirubin level in the blood should be less than or equal to 2.0 mg/dl.I have precursor B-cell acute lymphoblastic leukemia/lymphoma or plasma cell dyscrasias.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (lymphodepletion, cellular immunotherapy)
- Group 2: Group I (lymphodepletion, cellular immunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any capacity to join this clinical exploration?
"Per the details hosted on clinicaltrials.gov, this medical trial is not currently open to patient recruitment - though it was initially posted on September 24th 2014 and last edited on July 31st 2022. Fortunately, there are 4,906 other trials actively recruiting at present."
Answered by AI
What evidence exists that suggests Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes are useful for medical treatment?
"Currently, there are 1114 active clinical trials examining Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T lymphocytes across 224 Phase 3 studies. Philadelphia is the epicentre of this research with many such trails occurring in that city. However, 40687 other sites around America have also undertaken these types of investigations."
Answered by AI
Has the FDA approved Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes?
"As this is an experimental Phase 1 study, the safety of Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes was given a score of 1 due to limited evidence regarding its efficacy and safety."
Answered by AI
What is the magnitude of this clinical research study?
"This research has ceased its search for study subjects, with the original posting going up on September 24th 2014 and last update occurring on July 31st 2022. If you are seeking other clinical trials, there exist 3792 studies recruiting leukemia patients, as well as 1114 more that involve Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes."
Answered by AI
What medical purpose is Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes typically employed for?
"Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes is commonly used to treat Merkel cell cancer and has also been demonstrated as a viable treatment for multiple other forms of malignancy, such as leukemia, prostate cancer, and several types of lung cancers."
Answered by AI
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