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AzTrials

Primary Mediastinal B-cell LymphomaPhase 1/2NCT00924326

CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma

A Phase 1/2 study testing Fludarabine, Cyclophosphamide and Anti-cluster of differentiation 19 (CD19)-CAR PBL in people with Primary Mediastinal B-cell Lymphoma and Diffuse, Large B-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with B cell lymphomas or leukemias that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Fludarabine, Cyclophosphamide and Anti-cluster of differentiation 19 (CD19)-CAR PBL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
17 Feb 2009to 17 Nov 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have a cluster of differentiation 19 (CD19)-expressing B-cell lymphoma. Patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma must have measurable disease after at least two prior chemotherapy regimens one of which must have contained doxorubicin and rituximab.
  • Confirmation of diagnosis of B-cell malignancy and positivity for CD19 confirmed by the Laboratory of Pathology of the National Cancer Institute (NCI). The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient. Immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood, fine needle aspirates and bone marrow samples.
  • Patients must have indications for treatment for their B-cell malignancy at the time of enrollment on this trial.
  • Greater than or equal to 18 years of age and less than or equal to age 70.
  • Willing to sign a durable power of attorney.
  • Able to understand and sign the Informed Consent Document.
Show all 24Show fewer
  • Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Life expectancy of greater than three months.
  • Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.
  • Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
  • Serology:
  • Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune -competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.).
  • Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive. Then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative.
  • Hematology:
  • Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim.
  • Platelet count greater than or equal to 50,000/mm^3.
  • Hemoglobin greater than 8.0 g/dl.
  • Lymphocyte count less than or equal to 4,000/ mm^3
  • Chemistry:
  • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 5 times the upper limit of normal.
  • Serum creatinine less than or equal to 1.6 mg/dl
  • Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl
  • More than three weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patient toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).
  • Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram.

Who cannot join

  • Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.
  • Patients that have active hemolytic anemia.
  • Patients with active brain metastases, or with a history of any central nervous system (CNS) metastases or cerebrospinal fluid malignant cells.
  • Note: patients who are asymptomatic but are found to have malignant cells in the cerebrospinal fluid (CSF) on lumbar puncture prior to treatment will be considered eligible.
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
Show all 34Show fewer
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Concurrent systemic steroid therapy.
  • History of severe immediate hypersensitivity reaction to any of the agents used in this study.
  • History of allogeneic stem cell transplantation
  • Patients with cardiac atrial or cardiac ventricular lymphoma involvement.
  • Screening Evaluation:
  • Within 4 weeks prior to starting the chemotherapy regimen:
  • Complete history and physical examination, including, weight and vital signs, noting in detail the exact size and location of any lesions that exist. (Note: patient history may be obtained within 8 weeks.)
  • Chest x-ray
  • Electrocardiography (EKG)
  • Baseline computed tomography (CT) of the chest, abdomen and pelvis, positron emission tomography (PET) scan, and brain magnetic resonance imaging (MRI) to evaluate the status of disease. Additional scans and x-rays may be performed if clinically indicated based on patient signs and symptoms.
  • HIV antibody titer and Hepatitis B surface antigen (HbsAG) determination, and anti HCV, (Note: May be performed within 3 months of the chemotherapy start date).
  • Anti cytomegalovirus (CMV) antibody titer, herpes simplex virus (HSV) serology, and Epstein-Barr virus (EBV) panel (Note: patients who are known to be positive for any of the above do not need to be retested; may be performed within 3 months of chemotherapy start date)
  • Patients with a left ventricular ejection fraction (LVEF) of less than or equal to 55% will not proceed to treatment (Note: may be performed within 8 weeks of treatment).
  • Cluster of differentiation 19 (CD19) staining of malignant cells by immunohistochemistry or flow cytometry (testing is permitted to be conducted at any time prior to this point).
  • All patients must have a T cells, B cells, and natural killer cells (TBNK) for Peripheral blood cluster of differentiation 3 (CD3) count and CD19#.
  • Patients with a history of leptomeningeal disease, or signs/symptoms suggestive of leptomeningeal involvement, or with symptoms of central nervous system malignancy such as new onset severe headaches, neck stiffness, or any focal neurologic findings on physical exam will have lumbar puncture for examination of cerebral spinal fluid.
  • Patients may undergo lumbar puncture (LP) for flow cytometry of the CSF in order to assess the presence of CD19 positive lymphocytes for potential correlation with neurologic toxicity. Patients who have no neurologic symptoms at the time of LP will be eligible for enrollment regardless of the results of the flow cytometry.
  • Within 14 days prior to starting the chemotherapy regimen:
  • Chem 20: (Sodium (Na), Potassium (K), Chloride (Cl), Total carbon dioxide (CO2) (bicarbonate), Creatinine, Glucose, Urea nitrogen (BUN), Albumin, Calcium total, Magnesium total (Mg), Inorganic Phosphorus, Alkaline Phosphatase, ALT/glutamic pyruvic transaminase (GPT), AST/glutamic oxaloacetic (GOT), Total Bilirubin, Direct Bilirubin, lactate hydrogenase (LD), Total Protein, Total creatine kinase (CK), Uric Acid)
  • Thyroid panel
  • Complete blood count (CBC) with differential and platelet count
  • Prothrombin time (PT)/partial thromboplastin time (PTT)
  • Urinalysis and culture, if indicated
  • Within 7 days prior to starting the chemotherapy regimen:
  • Beta-human chorionic gonadotropin (βHCG) pregnancy test (serum or urine) on all women of child-bearing potential
  • ECOG performance status of 0 or 1

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma

Background:

The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with B cell lymphomas or leukemias that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-cluster of differentiation 19 (CD19) incorporated in the retrovirus.

Read more

Objective:

The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink.

Eligibility:

  • Adults age 18-70 with B cell lymphomas or leukemias expressing the CD19 molecule.

Design:

Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed

Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-CD19 cells. Leukapheresis is a common procedure, which removes only the white blood cells from the patient.

Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about 4 weeks for the treatment.

Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.

Read the detailed description

BACKGROUND:

  • We have constructed a retroviral vector that encodes an anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) that recognizes the CD19 antigen. This chimeric receptor also contains the signaling domains of cluster of differentiation 28 (CD28) and cluster of differentiation 3 (CD3)-zeta. The retroviral vector can be used to mediate genetic transfer of this CAR to T cells with high efficiency (> 50%) without the need to perform any selection.
  • In co-cultures with CD19-expressing target cells, anti-CD19-CAR-transduced T-cells secreted significant amounts of interferon gamma (IFN-y) and interleukin 2 (IL-2).
  • We have developed a process for cryopreserving the cell product which may lead to the ability for this product to be manufactured at a central location and shipped to other institutions for treatment of a broader patient population

OBJECTIVE:

  • Primary objective:

--With the approval of amendment S, to determine the safety and feasibility of the administration of cryopreserved anti-CD19-CAR engineered peripheral blood lymphocytes with a non-myeloablative conditioning regimen in patients with Bcell lymphomas.

ELIGIBILITY:

Patients of 18 years of age or older must:

  • Have a CD19-expressing B-cell lymphoma
  • Be a non-responder to, or recurred after one or more standard chemotherapy-containing regimens for their malignancy
  • Currently require treatment due to progressive malignancy
  • Be deemed to be incurable by standard therapy

Patients may not have:

  • A history of allogeneic stem cell transplantation
  • Central nervous system (CNS) disease

DESIGN:

  • Peripheral blood mononuclear cells (PBMC) obtained by leukapheresis (approximately 5.0x 10^9 cells) will be cultured in the presence of anti-CD3 (muromonab-CD3 (OKT3)) and aldesleukin in order to stimulate T-cell proliferation.
  • Transduction is initiated by exposure of approximately 1.0x 10^8 to 5.0x 10^8 cells to retroviral vector supernatant containing the anti-CD19 CAR.
  • With the approval of Amendment S, patients will receive fludarabine and cyclophosphamide chemotherapy (NMA) for lymphodepletion, followed by cryopreserved anti-CD19-CAR-transduced T-cells.
  • Patients will be followed until disease progression.
  • Patients who have responded to treatment and then progress may receive one retreatment.
Being tested
Fludarabine, Cyclophosphamide, Anti-cluster of differentiation 19 (CD19)-CAR PBL, Aldesleukin
Keywords
B Cell Malignancies, T Cell Persistence, Immunotherapy, Cell Transfer, Leukemia, Chronic Lymphocytic Leukemia, CLL, Lymphoma
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating, Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FludarabineDrug

    Also called Fludara

    Days -5 to -1 (after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

  • CyclophosphamideDrug

    Also called Cytoxan

    Days -5 to -4: 60mg/kg intravenous (IV) over 60 minutes

  • Anti-cluster of differentiation 19 (CD19)-CAR PBLBiological

    Anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) peripheral blood lymphocytes ( PBL).

    Day 0 (two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

  • AldesleukinDrug

    Also called Interleukin-2, IL-2

    Day 0: 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

  • FludarabineDrug

    Also called Fludara

    Days -5 to -3 (after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

  • CyclophosphamideDrug

    Also called Cytoxan

    Days -5 to -3: 300mg/m^2 intravenous (IV) over 60 minutes

Study groups in NCT00924326
Study groupRoleWhat they receive
1x10^9-1x10^10+ high dose Interleukin-2ExperimentalNon-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + cryopreserved anti-CD19-CAR PBL
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Aldesleukin
1x10^9-1x10^10 + high dose RetreatExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Aldesleukin
0.5x10^7 cells/kgExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL
2.5x10^6 cells/kgExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL
1.0x10^6 cells/kgExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL
1.0x10^6 cells/kg (Reduced chemo)ExperimentalNot described
Receives: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Fludarabine; Drug: Cyclophosphamide
2.0x10^6 cells/kg (Reduced chemo)ExperimentalNot described
Receives: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Fludarabine; Drug: Cyclophosphamide
6.0x10^6 cells/kg (Reduced chemo)ExperimentalNot described
Receives: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Fludarabine; Drug: Cyclophosphamide
2.0x10^6 cells/kg (Moderate chemo)ExperimentalNot described
Receives: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Fludarabine; Drug: Cyclophosphamide
2.0x10^6 cells/kg (9-12 days culture)ExperimentalNot described
Receives: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma

    Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Measured: Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years

Secondary outcomes (1)

  1. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).

    Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Measured: Date treatment consent signed to date off study, approximately 101 months and 17 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2009 (estimated)
  2. Study start17 Feb 2009
  3. Primary completion30 Sep 2015
  4. Study completion17 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00924326
Sponsor's protocol ID
090082
Other IDs
09-C-0082
Status last verified
Dec 2021
First submitted
17 Jun 2009
Last updated
12 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kochenderfer JN, Rosenberg SA. Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors. Nat Rev Clin Oncol. 2013 May;10(5):267-76. doi: 10.1038/nrclinonc.2013.46. Epub 2013 Apr 2.

    PubMed 23546520

  • Kochenderfer JN, Dudley ME, Carpenter RO, Kassim SH, Rose JJ, Telford WG, Hakim FT, Halverson DC, Fowler DH, Hardy NM, Mato AR, Hickstein DD, Gea-Banacloche JC, Pavletic SZ, Sportes C, Maric I, Feldman SA, Hansen BG, Wilder JS, Blacklock-Schuver B, Jena B, Bishop MR, Gress RE, Rosenberg SA. Donor-derived CD19-targeted T cells cause regression of malignancy persisting after allogeneic hematopoietic stem cell transplantation. Blood. 2013 Dec 12;122(25):4129-39. doi: 10.1182/blood-2013-08-519413. Epub 2013 Sep 20.

    PubMed 24055823

  • James N. Kochenderfer, M.D., Mark E. Dudley, Ph.D., Sadik H. Kassim, Ph.D., Robert O. Carpenter, James C. Yang, MD, Giao Q. Phan, MD, Marybeth S. Hughes, MD, Richard M. Sherry, MD, Steven Feldman, Ph.D., David Spaner, MD, PhD, Debbie-Ann N. Nathan, RN, Kathleen E. Morton, RN, Mary Ann Toomey, RN, and Steven A. Rosenberg, M.D., Ph.D. Effective Treatment of Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma with Autologous T Cells Genetically-Engineered to Express an Anti-CD19 Chimeric Antigen Receptor. Oral Abstract Presentation 12-8-13 in New Orleans, LA at the American Society of Hematology annual meeting. Blood Annual Meeting abstract 2013. 122:168.

  • Kochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, Yang JC, Phan GQ, Hughes MS, Sherry RM, Raffeld M, Feldman S, Lu L, Li YF, Ngo LT, Goy A, Feldman T, Spaner DE, Wang ML, Chen CC, Kranick SM, Nath A, Nathan DA, Morton KE, Toomey MA, Rosenberg SA. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015 Feb 20;33(6):540-9. doi: 10.1200/JCO.2014.56.2025. Epub 2014 Aug 25.

    PubMed 25154820

  • Kochenderfer JN, Somerville RPT, Lu T, Shi V, Bot A, Rossi J, Xue A, Goff SL, Yang JC, Sherry RM, Klebanoff CA, Kammula US, Sherman M, Perez A, Yuan CM, Feldman T, Friedberg JW, Roschewski MJ, Feldman SA, McIntyre L, Toomey MA, Rosenberg SA. Lymphoma Remissions Caused by Anti-CD19 Chimeric Antigen Receptor T Cells Are Associated With High Serum Interleukin-15 Levels. J Clin Oncol. 2017 Jun 1;35(16):1803-1813. doi: 10.1200/JCO.2016.71.3024. Epub 2017 Mar 14.

    PubMed 28291388

  • James N. Kochenderfer, Mark E. Dudley, Robert O. Carpenter, Sadik H. Kassim, Jeremy J. Rose, William G. Telford, Frances T. Hakim, David C. Halverson, Daniel H. Fowler, Nancy M. Hardy, Anthony R. Mato, Dennis D. Hickstein, Juan C. Gea-Banacloche, Steven Z. Pavletic, Claude Sportes, Irina Maric, Steven A. Feldman, Brenna G. Hansen, Jennifer S. Wilder, Bazetta Blacklock-Schuver, Bipulendu Jena, Michael R. Bishop, Steven A. Rosenberg*, Ronald E. Gress* (co-senior authors). Donor-derived anti-CD19 chimeric-antigen-receptor-expressing T cells cause regression of malignancy persisting after allogeneic hematopoietic stem cell transplantation. Oral Abstract Presentation 12-8-13 in New Orleans, LA at the American Society of Hematology annual meeting. Blood Annual Meeting abstracts 2013. 122:151.

  • Kochenderfer, J.N., Somerville, R., Lu, T., Shi, V., Yang, J.C., Sherry, R., Klebanoff, C., Kammula, U.S., Goff, S.L., Bot, A., Rossi, J., Sherman, M., Perez, A., Xue, A., Feldman, T.A., Friedberg, J.W., Roschewski, M.J., Feldman, S., McIntyre, L., Rosenberg, S.A. Anti-CD19 Chimeric Antigen Receptor T cells Preceded by Low-Dose Chemotherapy to Induce Remissions of Advanced Lymphoma. 2016 ASCO Annual Meeting. J Clin Oncol 34, 2016 (suppl; abstr LBA3010).

  • Kochenderfer JN, Somerville RPT, Lu T, Yang JC, Sherry RM, Feldman SA, McIntyre L, Bot A, Rossi J, Lam N, Rosenberg SA. Long-Duration Complete Remissions of Diffuse Large B Cell Lymphoma after Anti-CD19 Chimeric Antigen Receptor T Cell Therapy. Mol Ther. 2017 Oct 4;25(10):2245-2253. doi: 10.1016/j.ymthe.2017.07.004. Epub 2017 Jul 13.

    PubMed 28803861

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PubMed 34515338

  • Cappell KM, Sherry RM, Yang JC, Goff SL, Vanasse DA, McIntyre L, Rosenberg SA, Kochenderfer JN. Long-Term Follow-Up of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy. J Clin Oncol. 2020 Nov 10;38(32):3805-3815. doi: 10.1200/JCO.20.01467. Epub 2020 Oct 6.

    PubMed 33021872

  • Rossi J, Paczkowski P, Shen YW, Morse K, Flynn B, Kaiser A, Ng C, Gallatin K, Cain T, Fan R, Mackay S, Heath JR, Rosenberg SA, Kochenderfer JN, Zhou J, Bot A. Preinfusion polyfunctional anti-CD19 chimeric antigen receptor T cells are associated with clinical outcomes in NHL. Blood. 2018 Aug 23;132(8):804-814. doi: 10.1182/blood-2018-01-828343. Epub 2018 Jun 12.

    PubMed 29895668

  • Kochenderfer JN, Dudley ME, Feldman SA, Wilson WH, Spaner DE, Maric I, Stetler-Stevenson M, Phan GQ, Hughes MS, Sherry RM, Yang JC, Kammula US, Devillier L, Carpenter R, Nathan DA, Morgan RA, Laurencot C, Rosenberg SA. B-cell depletion and remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells. Blood. 2012 Mar 22;119(12):2709-20. doi: 10.1182/blood-2011-10-384388. Epub 2011 Dec 8.

    PubMed 22160384

  • Kochenderfer JN, Wilson WH, Janik JE, Dudley ME, Stetler-Stevenson M, Feldman SA, Maric I, Raffeld M, Nathan DA, Lanier BJ, Morgan RA, Rosenberg SA. Eradication of B-lineage cells and regression of lymphoma in a patient treated with autologous T cells genetically engineered to recognize CD19. Blood. 2010 Nov 18;116(20):4099-102. doi: 10.1182/blood-2010-04-281931. Epub 2010 Jul 28.

    PubMed 20668228

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fludarabine, Cyclophosphamide and Anti-cluster of differentiation 19 (CD19)-CAR PBL in people with Primary Mediastinal B-cell Lymphoma and Diffuse, Large B-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma (time frame: Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00924326, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.

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