Relapsed Non Hodgkin LymphomaPhase 1NCT05053659
Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma
A Phase 1 study testing Loncastuximab tesirine and Venetoclax in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by Paolo Caimi, MD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- What is being tested?
- Loncastuximab tesirine and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologic or cytologic diagnosis of non-Hodgkin lymphoma, with the exclusion of small lymphocytic lymphoma/chronic lymphocytic leukemia.
- --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.
- Participants must have received ≥2 prior systemic therapies for their lymphoma.
- Participants must have measurable disease as defined by the 2014 Lugano Classification.
- Participants must meet clinical indications for treatment.
- ECOG performance status ≤ 2 (see Appendix I)
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- Adequate bone marrow function, defined by the following laboratory parameters
- 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 organ function, defined by the following laboratory parameters
- 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)
- Calculated creatinine clearance > 30 mL/min by the Cockcroft-Gault equation.
- 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).
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- -For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- --With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of loncastuximab. Men must refrain from donating sperm during this same period.
- With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of loncastuximab to avoid exposing the embryo.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- 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
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- 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.
- All medications that fall in these categories should be discontinued 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- 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.
- Congenital long QT syndrome or a Fridericia correction of the QT measure (QTcF) interval of > 480 ms at screening (unless secondary to pacemaker or bundle branch block)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase I Trial of Loncastuximab Tesirine and Venetoclax for Treatment of Relapsed/ Refractory Non-Hodgkin Lymphoma
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.
Read the detailed description
This is a phase I trial designed to evaluate the safety and tolerability of loncastuximab tesirine given in combination with venetoclax for treatment of relapsed/refractory non - Hodgkin lymphoma.
Loncastuximab tesirine is an investigational (experimental) drug that works by targeting a protein in cancer cells (called CD19) and delivering a small amount of chemotherapy directly to the cancer cells. Loncastuximab tesirine is experimental because it is not approved by the Food and Drug Administration (FDA). Venetoclax, is a targeted anti-cancer drug, which works by imitating a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the loncastuximab tesirine regimen is believed to increase the chance of getting relapsed or refractory B cell lymphoma cancer in remission. Venetoclax is approved by the FDA for treatment in some types of cancer, but is not approved by the FDA for the treatment of lymphoma soit is considered experimental in this study. Up to 36 subjects will take in this phase I research study.
The primary objective for this study: To determine the safety and tolerability of the combination of loncastuximab tesirine and venetoclax to identify the recommended phase 2 dose (RP2D) of these agents.
Secondary objectives are:
- To describe the adverse event profile of the combination of loncastuximab tesirine and venetoclax.
- To describe the overall response rate (ORR) and complete response rate (CRR) of relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
- To describe the overall survival (OS) and progression free survival (PFS) of subjects with relapsed / refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
- To describe the disease-free survival, the disease specific survival and time to treatment failure of subjects with relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
- Being tested
- Loncastuximab tesirine, Venetoclax
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab tesirineDrug
Also called ADCT-402, lonca
Loncastuximab tesirine 50 - 150 μg/kg will be administered as a 30 minutes IV infusion on Day 1 of each cycle for 6 cycles. On doses over 100 μg/kg, subsequent dosing (i.e. beyond 100 μg/kg) will be done at 50% of the dose that is administered on the first 2 cycles.
VenetoclaxDrug
Also called ABT-199, GDC-0199
Participants will receive venetoclax at target doses of 400 - 800mg orally on days 1 - 5 of each (21 day) cycle.
On cycle 1, venetoclax dose will be escalated to reach the target dose over the course of 5 days for target dose 400mg, 6 days for target dose 600mg and 7 days for target dose 800mg
Venetoclax should preferably be given after a meal and on cycle 1 should be preceded by prophylaxis for tumor lysis syndrome (TLS).
| Study group | Role | What they receive |
|---|---|---|
| Loncastuximab tesirine & venetoclax | Experimental | Participants will receive a baseline disease assessment via PET/CT in FDG avid lymphomas; CT scan (chest, abdomen, pelvis; inclusion of neck in selected cases). Bome marrow biopsy in selected cases.
Premedication includes:
* Allopurinol (to reduce uric acid) 300mg orally daily starting day -1 and continuing at least until day 7 of each cycle.
* Dexamethasone (steroid pre-medication) 4mg orally twice daily on day -1, day 1 and day 2 of each cycle.
* Adequate oral hydration starting on day -1 or -2, defined as 1 - 2 liters of oral intake of liquids in 24 hours
Study treatment to be given every 21 days.
* Loncastuximab tesirine (50 - 150 μg/kg) intravenously (IV) on day 1 of each 21-day cycle
* Venetoclax (400 - 800 mg) orally, every day on days 1 - 5 of each 21-day cycle. Dose ramp-up on cycle 1 (over days 1 - 5 for target dose 400mg, 1 - 6 for target dose 600mg and 1 - 7 for target dose 800mg Receives: Drug: Loncastuximab tesirine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs) during cycle 1 of loncastuximab tesirine and venetoclax
Number of DLTs during cycle 1 (21 days) of loncastuximab tesirine and venetoclax
Measured: Up to Day 21
Maximum tolerated dose (MTD) of loncastuximab tesirine and venetoclax
Number of MTDs of loncastuximab tesirine and venetoclax
Measured: 6 weeks
Secondary outcomes (17)
Overall response rate (ORR) as measured by proportion of participants with Complete Response (CR) and Partial Response (PR)
ORR, described as proportion of participants with CR and PR. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: Day 5 of cycle 1 (each cycle is 21 days)
Overall response rate (ORR) as measured by proportion of participants with CR or PR
ORR, described as proportion of participants with CR and PR. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: Between cycle 3 and 4 (21-day cycles) +/- 7 days
Overall response rate (ORR) as measured by proportion of participants with CR or PR
ORR, described as proportion of participants with CR and PR. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: End of treatment, aproximately day 84 +/- 7 days
Overall response rate (ORR)
ORR, described as a proportion. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: Followup, every 3 months up to one year after end of treatment
Complete response rate (CRR) as measured by proportion of participants with CR
ORR, described as a proportion. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: Day 5 of cycle 1 (each cycle is 21 days)
Complete response rate (CRR)
ORR, described as a proportion. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: Between cycle 3 and 4 (21-day cycles) +/- 7 days
Complete response rate (CRR)
ORR, described as a proportion. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: End of treatment, aproximately day 84 +/- 7 days
Complete response rate (CRR)
ORR, described as a proportion. Response assessed via Revised Response Criteria for Malignant Lymphoma
Measured: Followup, every 3 months up to one year after end of treatment
Overall survival (OS)
OS is defined as the time from the date of study entry to the date of death, with censoring done on live patients at the time of last follow up. OS will be estimated using the Kaplan Meier method
Measured: At end of follow-up (1 year)
Progression free survival (PFS)
PFS is defined as the time from entry onto study until lymphoma progression or death from any cause. PFS will be estimated using the Kaplan Meier method
The precise date of progression is generally unknown. It may be defined as the first date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed. Where there is missing information, censoring of the data may be defined as the last date at which progression status was adequately assessed or the first date of unscheduled new anti-lymphoma treatment.
Measured: At end of follow-up (1 year)
Median disease-free survival
Disease-free survival is measured from the time of occurrence of disease-free state (e.g. the adjuvant setting following surgery or radiation therapy) or attainment of a complete remission) to disease recurrence or death from lymphoma or acute toxicity of treatment.
Measured: At end of follow-up (1 year)
Median disease-specific survival
Disease-specific survival is defined as death from lymphoma, or from toxicity from the drug. Death from unknown causes should be attributed to the drug
Measured: At end of follow-up (1 year)
Time-to-treatment failure
Time to treatment failure (event-free survival) is measured from the time from study entry to any treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death.
Measured: At end of follow-up (1 year)
Total number of adverse events during and after treatment
The objective is to describe the adverse event profile of the combination therapy by reporting number of adverse events during and after treatment, described as a proportion
Measured: At end of treatment (21-day cycles until disease progression or toxicity, up to 6 cycles max)
Duration of response (DOR)
DOR, as measured by the median time in months of from first response (PR or CR) until relapse or death, using Kaplan Meier
Measured: At end of follow-up (1 year)
Time to Progression (TTP)
TTP as measured by median time in months from treatment to death or relapse
Measured: At end of follow-up (1 year)
Partial response rate (PRR)
PRR, as measured by proportion of patients with partial response
Measured: At end of follow-up (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start20 Jun 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Caimi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Caimi, MD, Case Comprehensive Cancer Center
- Investigators
- Paolo Caimi, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053659
- Sponsor's protocol ID
- CASE5420
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share Individual Participant Data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Loncastuximab Tesirine and Venetoclax for Treatment of Relapsed/ Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05053659
- Acronym / sponsor ID
- CASE5420
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Paolo Caimi, MDUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I trial designed to evaluate the safety and tolerability of loncastuximab tesirine given in combination with venetoclax for treatment of relapsed/refractory non - Hodgkin lymphoma.
Loncastuximab tesirine is an investigational (experimental) drug that works by targeting a protein in cancer cells (called CD19) and delivering a small amount of chemotherapy directly to the cancer cells. Loncastuximab tesirine is experimental because it is not approved by the Food and Drug Administration (FDA). Venetoclax, is a targeted anti-cancer drug, which works by imitating a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the loncastuximab tesirine regimen is believed to increase the chance of getting relapsed or refractory B cell lymphoma cancer in remission. Venetoclax is approved by the FDA for treatment in some types of cancer, but is not approved by the FDA for the treatment of lymphoma soit is considered experimental in this study. Up to 36 subjects will take in this phase I research study.
The primary objective for this study: To determine the safety and tolerability of the combination of loncastuximab tesirine and venetoclax to identify the recommended phase 2 dose (RP2D) of these agents.
Secondary objectives are:
- To describe the adverse event profile of the combination of loncastuximab tesirine and venetoclax.
- To describe the overall response rate (ORR) and complete response rate (CRR) of relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
- To describe the overall survival (OS) and progression free survival (PFS) of subjects with relapsed / refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
- To describe the disease-free survival, the disease specific survival and time to treatment failure of subjects with relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loncastuximab tesirine & venetoclax | Experimental | Drug: Loncastuximab tesirine, Drug: VenetoclaxParticipants will receive a baseline disease assessment via PET/CT in FDG avid lymphomas; CT scan (chest, abdomen, pelvis; inclusion of neck in selected cases). Bome marrow biopsy in selected cases. Premedication includes: * Allopurinol (to reduce uric acid) 300mg orally daily starting day -1 and continuing at least until day 7 of each cycle. * Dexamethasone (steroid pre-medication) 4mg orally twice daily on day -1, day 1 and day 2 of each cycle. * Adequate oral hydration starting on day -1 or -2, defined as 1 - 2 liters of oral intake of liquids in 24 hours Study treatment to be given every 21 days. * Loncastuximab tesirine (50 - 150 μg/kg) intravenously (IV) on day 1 of each 21-day cycle * Venetoclax (400 - 800 mg) orally, every day on days 1 - 5 of each 21-day cycle. Dose ramp-up on cycle 1 (over days 1 - 5 for target dose 400mg, 1 - 6 for target dose 600mg and 1 - 7 for target dose 800mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must have histologic or cytologic diagnosis of non-Hodgkin lymphoma, with the exclusion of small lymphocytic lymphoma/chronic lymphocytic leukemia.
- --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.
- Participants must have received ≥2 prior systemic therapies for their lymphoma.
- Participants must have measurable disease as defined by the 2014 Lugano Classification.
- Participants must meet clinical indications for treatment.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loncastuximab tesirineAlso: ADCT-402, loncaLoncastuximab tesirine 50 - 150 μg/kg will be administered as a 30 minutes IV infusion on Day 1 of each cycle for 6 cycles. On doses over 100 μg/kg, subsequent dosing (i.e. beyond 100 μg/kg) will be done at 50% of the dose that is administered on the first 2 cycles. | Drug | Loncastuximab tesirine & venetoclax |
| VenetoclaxAlso: ABT-199, GDC-0199Participants will receive venetoclax at target doses of 400 - 800mg orally on days 1 - 5 of each (21 day) cycle. On cycle 1, venetoclax dose will be escalated to reach the target dose over the course of 5 days for target dose 400mg, 6 days for target dose 600mg and 7 days for target dose 800mg Venetoclax should preferably be given after a meal and on cycle 1 should be preceded by prophylaxis for tumor lysis syndrome (TLS). | Drug | Loncastuximab tesirine & venetoclax |
Primary outcome
Dose limiting toxicities (DLTs) during cycle 1 of loncastuximab tesirine and venetoclax
Time frame: Up to Day 21
Number of DLTs during cycle 1 (21 days) of loncastuximab tesirine and venetoclax
Maximum tolerated dose (MTD) of loncastuximab tesirine and venetoclax
Time frame: 6 weeks
Number of MTDs of loncastuximab tesirine and venetoclax
17 secondary outcomes
Overall response rate (ORR) as measured by proportion of participants with Complete Response (CR) and Partial Response (PR)
Time frame: Day 5 of cycle 1 (each cycle is 21 days)
Overall response rate (ORR) as measured by proportion of participants with CR or PR
Time frame: Between cycle 3 and 4 (21-day cycles) +/- 7 days
Overall response rate (ORR) as measured by proportion of participants with CR or PR
Time frame: End of treatment, aproximately day 84 +/- 7 days
Overall response rate (ORR)
Time frame: Followup, every 3 months up to one year after end of treatment
Complete response rate (CRR) as measured by proportion of participants with CR
Time frame: Day 5 of cycle 1 (each cycle is 21 days)
Complete response rate (CRR)
Time frame: Between cycle 3 and 4 (21-day cycles) +/- 7 days
Complete response rate (CRR)
Time frame: End of treatment, aproximately day 84 +/- 7 days
Complete response rate (CRR)
Time frame: Followup, every 3 months up to one year after end of treatment
Overall survival (OS)
Time frame: At end of follow-up (1 year)
Progression free survival (PFS)
Time frame: At end of follow-up (1 year)
Median disease-free survival
Time frame: At end of follow-up (1 year)
Median disease-specific survival
Time frame: At end of follow-up (1 year)
Time-to-treatment failure
Time frame: At end of follow-up (1 year)
Total number of adverse events during and after treatment
Time frame: At end of treatment (21-day cycles until disease progression or toxicity, up to 6 cycles max)
Duration of response (DOR)
Time frame: At end of follow-up (1 year)
Time to Progression (TTP)
Time frame: At end of follow-up (1 year)
Partial response rate (PRR)
Time frame: At end of follow-up (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. No plans to share Individual Participant Data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Caimi, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Loncastuximab tesirine and Venetoclax in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by Paolo Caimi, MD 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 21 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Dose limiting toxicities (DLTs) during cycle 1 of loncastuximab tesirine and venetoclax (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.