Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05052528

Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Led by Mehrdad Abedi, MD · Updated on 2024-05-13

36

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

M

Mehrdad Abedi, MD

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial evaluates the best dose, possible benefits and/or side effects of fludarabine and cyclophosphamide with or without rituximab before CD19 chimeric antigen receptor T cells in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or has not responded to previous treatment (refractory). T-cells are a normal part of the immune system. To make the T-cell medication, T-cells are taken from the blood and altered in a laboratory. They are then returned to the body. The altered T-cells will latch on to a specific part of the cancer cells and hopefully kill them. Once the T-cells have been altered in the laboratory, they are called "CAR T-cells." CAR is short for "chimeric antigen receptors." These are structures on the surface of cells that allow the altered T-Cells to find and destroy the cancer cells. Another part of the T-Cell medication is called "CD19." This part is called a "biomarker." Biomarkers help doctors determine whether a cancer is getting worse and whether medications are working to stop it. The chemotherapy drugs that are given before the T-Cell therapy are cyclophosphamide, fludarabine and rituximab. Rituximab is an immunotherapy drug. These chemotherapy drugs will reduce the number of normal (unaltered) T-Cells in the body to make room for the altered T-cells to kill the cancer cells. Giving fludarabine and cyclophosphamide with or without rituximab before CD19 CAR T cell therapy may help improve response to CD19 CAR T cell therapy in patients with diffuse large B-cell lymphoma.

CONDITIONS

Official Title

Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form provided
  • Willingness to follow all study procedures and be available for the full study duration
  • No commercial CD19 CAR T cell product available
  • Male or female aged 18 years or older
  • In good general health as deemed by the investigator
  • Able to swallow oral medication and willing to follow study treatments
  • Females of childbearing potential must use effective contraception and have a negative pregnancy test
  • Males of reproductive potential must use condoms or effective contraception
  • Agree to avoid tobacco and drug use during the study
  • Diagnosis of relapsed or refractory diffuse large B cell lymphoma after at least two prior therapies
  • Disease must be CD19 positive by biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better for adults
  • Absolute neutrophil count (ANC) of at least 1000 (or 500 with bone marrow involvement)
  • Platelet count of 100,000/mm3 or higher
  • Hemoglobin greater than 8 g/dL
  • Kidney function with creatinine clearance of 50 cc/min or more
  • Total bilirubin 2 mg/dL or less (up to 3 mg/dL if Gilbert's Syndrome)
  • Liver enzymes (ALT and AST) within 3 times the upper limit of normal (or 5 times if liver involved)
  • Cardiac ejection fraction 45% or greater with no significant ECG abnormalities
  • Oxygen saturation over 92% on room air
  • At least 2 weeks since prior systemic therapy
  • No use of lymphodepleting agents for 7 days before blood collection and for 90 days after CAR T cell infusion
Not Eligible

You will not qualify if you...

  • Use of supplemental oxygen or presence of cardiac pacemaker
  • Known allergy to components of the anti-CD19 CAR T cell product
  • Fever within 3 days before starting lymphodepleting chemotherapy
  • Treatment with other investigational drugs within 2 weeks before blood collection
  • Primary immunodeficiency
  • Autoimmune diseases causing organ damage or requiring immunosuppressive drugs within 2 years
  • Recent autologous transplant within 6 weeks or allogeneic transplant within 3 months
  • Prior CD19 CAR T cell therapy outside this study
  • Active central nervous system or meningeal tumor involvement
  • Untreated brain metastases or central nervous system disease
  • History of other active cancers except certain non-melanoma skin cancers or carcinoma in situ
  • Active HIV infection
  • Uncontrolled concurrent illness including infections, heart failure, unstable angina, arrhythmias, psychiatric illness, or social issues affecting compliance
  • Pregnant or breastfeeding women
  • Diagnosis of myelodysplasia
  • Active hepatitis B or C infection confirmed by positive viral load

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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