A Phase 1/2 interventional study of Interferon Beta-1A and X-Ray Imaging in Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Non-Hodgkin Lymphoma and Refractory B Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Prevention
This phase I/II trial tests the safety and how well intravenous interferon-beta-1a (FP-1201) works in preventing toxicities after CD19-directed chimeric antigen receptor (CAR) T-cell therapy in patients with B-cell cancers that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Interferon beta-1a is in a class of medications called immunomodulators. It works by protecting the lining of blood vessels, and preventing brain inflammation. Giving FP-1201 may prevent cytokine release syndrome (CRS) and immune effector cell associated-neurotoxicity syndrome (ICANS) toxicities in patients receiving CD19 CAR T-cell therapy with recurrent or refractory B-cell malignancies.
OUTLINE: This is a dose-escalation study of FP-1201.
Patients undergo leukapheresis prior to treatment and receive FP-1201 intravenously (IV) for 3 days every 24 hours from day -3 through day -1 or for 5 days every 24 hours from day -5 through day -1 or on day -5, day -3, and day -1. Patients may receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -5, -4, -3 followed by axi-cel IV or brexu-cel IV on day 0 or fludarabine IV over 30 minutes on days -4, -3, and -2 and cyclophosphamide IV over 60 minutes on day -2 followed by brexu-cel IV on day 0. Patients undergo x-ray imaging and echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT as well as lumbar puncture (LP) for cerebral spinal fluid (CSF) collection and/or bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection on study and during follow-up as well as a tissue biopsy during screening and follow-up.
After completion of study treatment, patients are followed up to 28 days and 90 days, then long-term for up to 15 years.
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Exclusion Criteria:
Significant cardiovascular abnormalities as defined by any one of the following:
Patients undergo leukapheresis prior to treatment and receive FP-1201 IV for 3 days every 24 hours from day -3 through day -1 or for 5 days every 24 hours from day -5 through day -1 or on day -5, day -3, and day -1. Patients may receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -5, -4, -3 followed by axi-cel IV or brexu-cel IV on day 0 or fludarabine IV over 30 minutes on days -4, -3, and -2 and cyclophosphamide IV over 60 minutes on day -2 followed by brexu-cel IV on day 0. Patients undergo x-ray imaging and ECHO or MUGA during screening. Patients also undergo CT or PET/CT as well as LP for CSF collection and/or bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection on study and during follow-up as well as a tissue biopsy during screening and follow-up.
Biological: Interferon Beta-1A · Procedure: X-Ray Imaging · Procedure: Echocardiography · Procedure: Multigated Acquisition Scan · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Procedure: Lumbar Puncture · Procedure: Bone Marrow Aspiration · Procedure: Bone Marrow Biopsy · Procedure: Biospecimen Collection · Procedure: Biopsy
Given IV
Also known as: 145258-61-3, Avonex, BG9418, Rebif, Recombinant interferon beta-1a
Undergo x-ray
Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray
Undergo ECHO
Also known as: EC
Undergo MUGA
Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning
Undergo CT
Also known as: CAT Scan, Computed Axial Tomography, Computerized axial tomography (procedure)
Undergo PET/CT
Also known as: Medical Imaging, Pet Scan, Positron emission tomography (procedure), Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Undergo LP
Also known as: LP, spinal tap
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo blood and CSF sample collection
Also known as: Biological Sample Collection
Undergo tissue biopsy
Also known as: BIOPSY_TYPE, Bx
Dose-limiting toxicity (DLT) rates
Will be summarized in the DLT evaluable population. Final DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm. The target toxicity rate is 30%.
Time frame: Within 14 days after the last administration of interferon-beta-1a (FP-1201)
Incidence of adverse events (AEs)
Type, frequency, and severity of AEs according to the National Cancer Institutes Common Terminology Criteria for Adverse Events version 5.0.
Time frame: From the first dose of FP-1201 through day 28 after chimeric antigen receptor (CAR) T-cell infusion
Cytokine release syndrome (CRS) rates
Will be assessed by any grade and grade \>= 3 by American Society for Transplantation and Cellular Therapy (ASTCT) criteria and will be summarized along the two-sided 95% Clopper-Pearson confidence interval (CI) based on the CRS and ICANS analysis set.
Time frame: From the time of CAR T-cell infusion through day 28 after CAR T-cell infusion or until resolution, whichever happens last
Immune effector cell associated-neurotoxicity syndrome (ICANS) rates
Will be assessed by any grade and grade \>= 3 by ASTCT criteria and will be summarized along the two-sided 95% Clopper-Pearson CI based on the CRS and ICANS analysis set.
Time frame: From the time of CAR T-cell infusion through day 28 after CAR T-cell infusion or until resolution, whichever happens last
Cumulative corticosteroids dose
Will be summarized using descriptive statistics (median, quantiles) based on the CRS and ICANS analysis set.
Time frame: Within 28 days after CAR T-cell infusion
Overall response rate
Will be assessed by the Lugano criteria for B-non-Hodgkin lymphoma (NHL) participants and National Comprehensive Cancer Network (NCCN) criteria for B- acute lymphoblastic leukemia (ALL) participants Will be summarized along with the two-sided Clopper-Pearson CI based on the anti-tumor response evaluable analysis set.
Time frame: 28 days after CAR T-cell infusion
Complete response rate
Will be assessed by the Lugano criteria for B-NHL participants and NCCN criteria for B-ALL participants Will be summarized along with the two-sided Clopper-Pearson CI based on the anti-tumor response evaluable analysis set.
Time frame: 28 days after CAR T-cell infusion
Plan to share: No
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