RECRUITING

Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma

Conditions

Relapsed Non Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the correct dose and safety of combining two new cancer drugs, loncastuximab tesirine and venetoclax, as a treatment for relapsed or refractory B cell lymphoma.These drugs are used to treat some lymphomas, but have not yet been tested in combination for the treatment of lymphoma. The main goal of this study is to determine the safety of the combination.

Official Title

Phase I Trial of Loncastuximab Tesirine and Venetoclax for Treatment of Relapsed/ Refractory Non-Hodgkin Lymphoma

Quick Facts

Study Start:2022-06-20

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05053659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with mantle cell lymphoma are not eligible for the dose escalation part of the study. Inclusion of patients with mantle cell lymphoma to the dose expansion part of the study will be done after an amendment delineates a MCL - specific venetoclax ramp up and tumor lysis syndrome prophylaxis and monitoring regimen. * Absolute neutrophil count of 1.0 x 109/L * Platelet count of 75 x 109/L; platelet count of 50 - 75 x 109/L are permitted in participants with marrow involvement by the lymphoma. Platelets must not have received a platelet transfusion in 7 days. * Adequate hepatic function, with transaminases (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and gamma glutammyltransferase \[GGT\]) ≤ 2.5 times the upper limit of normal; * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) * Serum creatinine ≤ 1.5 times the upper limit of normal. -For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax and at least 9 months after the last dose of loncastuximab tesirine for women. * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).	* Prior treatment toxicities not resolved to grade \<2 according to NCI CTCAE 5.0 (with the exception of alopecia or grade 2 sensory peripheral neuropathy). * Patients with spontaneous tumor lysis syndrome. * Autologous stem cell transplant within 30 days of start of study drug (C1D1). * Allogeneic stem cell transplant within 60 days of start of study drug (C1D1). * Women who are pregnant or breastfeeding. * Active graft versus host disease * Active autoimmune disease * Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus. Note: Testing is not mandatory to be eligible. * Malabsorption syndrome or other condition that precludes enteral route of administration. * Known allergy to both xanthine oxidase inhibitors and rasburicase. Allergy to only one of these agents does not constitute an exclusion criterion. * Use of strong CYP3A inhibitors or inducers. * Administration or consumption of any of the following within 3 days prior to the first dose of study drug: * Grapefruit or grapefruit products * Seville oranges (including marmalade containing Seville oranges) * Star fruit * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal) * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. * Other uncontrolled conditions including uncontrolled cardiovascular disease or arrythmia, decompensated diabetes or COPD.

Inclusion Criteria

Exclusion Criteria

* Patients with mantle cell lymphoma are not eligible for the dose escalation part of the study. Inclusion of patients with mantle cell lymphoma to the dose expansion part of the study will be done after an amendment delineates a MCL - specific venetoclax ramp up and tumor lysis syndrome prophylaxis and monitoring regimen.
* Absolute neutrophil count of 1.0 x 109/L
* Platelet count of 75 x 109/L; platelet count of 50 - 75 x 109/L are permitted in participants with marrow involvement by the lymphoma. Platelets must not have received a platelet transfusion in 7 days.
* Adequate hepatic function, with transaminases (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and gamma glutammyltransferase \[GGT\]) ≤ 2.5 times the upper limit of normal;
* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
* Serum creatinine ≤ 1.5 times the upper limit of normal. -For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax and at least 9 months after the last dose of loncastuximab tesirine for women.
* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).

* Prior treatment toxicities not resolved to grade \<2 according to NCI CTCAE 5.0 (with the exception of alopecia or grade 2 sensory peripheral neuropathy).
* Patients with spontaneous tumor lysis syndrome.
* Autologous stem cell transplant within 30 days of start of study drug (C1D1).
* Allogeneic stem cell transplant within 60 days of start of study drug (C1D1).
* Women who are pregnant or breastfeeding.
* Active graft versus host disease
* Active autoimmune disease
* Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus. Note: Testing is not mandatory to be eligible.
* Malabsorption syndrome or other condition that precludes enteral route of administration.
* Known allergy to both xanthine oxidase inhibitors and rasburicase. Allergy to only one of these agents does not constitute an exclusion criterion.
* Use of strong CYP3A inhibitors or inducers.
* Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
* Grapefruit or grapefruit products
* Seville oranges (including marmalade containing Seville oranges)
* Star fruit
* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
* Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
* Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
* Other uncontrolled conditions including uncontrolled cardiovascular disease or arrythmia, decompensated diabetes or COPD.

Contacts and Locations

Study Contact

Brian Hill, MD, PhD

CONTACT

1-866-223-8100

TaussigResearch@ccf.orgarch@ccf.org

Principal Investigator

Brian Hill, MD, PhD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Brian Hill

Brian Hill, MD, PhD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-20

Study Completion Date2025-02

Study Record Updates

Study Start Date2022-06-20

Study Completion Date2025-02

Terms related to this study

Additional Relevant MeSH Terms

Relapsed Non Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma