Relapsed Diffuse Large B-cell LymphomaPhase 2NCT05222438
Trial of Loncastuximab Tesirine in High Risk Diffuse Large B-cell Lymphoma Post Transplant
A Phase 2 study testing loncastuximab tesirine in people with Relapsed Diffuse Large B-cell Lymphoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
Study of loncastuximab tesirine administered intravenously (IV) for maintenance therapy following autologous stem cell transplant in patients with relapsed diffuse large B cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Diffuse Large B-cell Lymphoma
- What is being tested?
- loncastuximab tesirine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Signed informed consent form (ICF)
- Age >18 years
- Patients with relapsed refractory DLBCL with any of the following high-risk features for progression following autoSCT will be enrolled:
- Primary refractory lymphoma (failure to achieve complete remission as determined by the treating physician) following 1st line anthracycline containing chemotherapy
- Early relapsed lymphoma with an initial remission duration of less than 12 months following 1st line anthracycline containing chemotherapy
- Failure to achieve complete remission following salvage chemotherapy and positive PET-CT as defined by Lugano criteria (Deauville score of 4 or 5) prior to autoSCT
Show all 20Show fewer
- Double hit lymphoma (DHL) or triple hit lymphoma (THL) confirmed by FISH testing by local pathology (defined as high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements)
- Double expressor lymphoma (DEL) as confirmed by immunohistochemistry (IHC) by local pathology (MYC and BCL2 or BCL6 positivity)
- CMYC rearranged (by FISH) DLBCL
- High IPI score (≥3 points)
- Stage 3-4 disease at diagnosis
- Extra-lymphatic disease
- High grade B cell lymphoma
- Eligible to undergo autologous stem cell transplantation as per local investigator assessment
- Availability of biopsy specimens confirming DLBCL relapse. Archival formalin-fixed paraffin-embedded (FFPE) tissue blocks or 15 unstained slides serial sections (5-10 μm in thickness) must be available prior to study enrollment. The pathology report must be available. IHC testing of CMYC, BCL2, and BCL6 expression, and FISH testing of CMYC, BCL2 and BCL6 gene rearrangement must be available prior to enrollment. CD19 expression status must be available prior to enrollment.
- Patients previously treated with CD19-targeted therapy (including CAR T) must have a subsequent biopsy and/or flow cytometry confirming CD19 positivity.
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 6 months
- Ability and willingness to comply with the study protocol procedures
- Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the patient receives his last dose of loncastuximab tesirine
Who cannot join
- Contraindications to any of the individual components of autoSCT or loncastuximab tesirine.
- Prior exposure to loncastuximab tesirine
- Clinically significant effusion i.e. ascites, pleural or pericardial effusion requiring drainage or associated with shortness of breath
- Patients with ongoing toxicities of grade >1 from previous treatments except alopecia
- Patients with clinically significant history of liver disease including cirrhosis or hepatitis (viral hepatitis). However, treated viral hepatitis may be allowed Patients with history of severe skin disorders including Steven-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
- Patients who are receiving any other investigational agents
Show all 26Show fewer
- Grade 3b follicular lymphoma
- Burkitt's lymphoma
- Patients with known brain, spinal, or CSF involvement
- Systemic steroids (prednisone >20 mg/day or equivalent) and/or immunosuppressive medications
- Unstable cardiovascular function that could affect compliance with the protocol:
- Symptomatic ischemia, or
- Congestive heart failure (CHF) of NYHA Class ≥3, or
- Myocardial infarction (MI) within 3 months
- Left ventricular ejection fraction <45% based on echocardiogram or MUGA scan obtained within 6 months prior to enrollment
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block.
- Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg]):
- -Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core antibody [HBcAb]) may be included if HBV DNA PCR is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle of study treatment. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible.
- Known history of HIV seropositive status
- Patients with a history of progressive multifocal leukoencephalopathy
- Any of the following, unless abnormal laboratory values are due to underlying lymphoma per the investigator:
- Creatinine > 1.5 x ULN or a measured creatinine clearance < 40 mL/min
- AST or ALT > 2.5 x ULN
- Total bilirubin > 1.5 x ULN. Patients with documented Gilbert disease may be enrolled if total bilirubin is < 3 x ULN
- INR or PT > 1.5 x ULN in the absence of therapeutic anticoagulation
- PTT or aPTT > 1.5 x ULN in the absence of a lupus anticoagulant
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Phase II Trial Evaluating Safety and Efficacy of Loncastuximab Tesirine as a Maintenance Therapy Following Autologous Stem Cell Transplantation in High Risk Diffuse Large B-cell Lymphoma
Study of loncastuximab tesirine administered intravenously (IV) for maintenance therapy following autologous stem cell transplant in patients with relapsed diffuse large B cell lymphoma
Read the detailed description
This is a Phase II, multicenter, open label study of loncastuximab tesirine for maintenance therapy following autologous stem cell transplant (autoSCT) in patients with relapsed diffuse large B cell lymphoma (DLBCL). Patients with relapsed DLBCL confirmed through core biopsy and meeting eligibility criteria will be enrolled in the study. Patients can be enrolled up to 4 weeks prior to autoSCT. Patients will start loncastuximab tesirine between day 30 and 60 after autoSCT as determined by the treating physician. Since majority of the relapses occur early after autoSCT, offering maintenance therapy for a finite duration might be of therapeutic benefit without posing excessive toxicity. Loncastuximab tesirine will be administered intravenously (IV) at every 3 weeks (Q3W) for a total of 6 months (8 cycles).
- Conditions
- Relapsed Diffuse Large B-cell Lymphoma
- Being tested
- loncastuximab tesirine
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loncastuximab tesirineDrug
loncastuximab tesirine for maintenance therapy between day 30 and 60 following autoSCT and will receive a total of 6 months of therapy (8 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Loncastuximab tesirine | Experimental | Patients will start loncastuximab tesirine for maintenance therapy between day 30 and 60 following autoSCT and will receive a total of 6 months of therapy (8 cycles). Patients will receive IV infusion of loncastuximab tesirine 150 μg/kg at Q3W for the first 2 cycles followed by 75 μg/kg at Q3W for the remaining 6 cycles. Receives: Drug: loncastuximab tesirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Outcome Measure
Progression-free survival (PFS) assessments will be determined according to Lugano Response Criteria. The distributions of time to event data will be graphically summarized using Kaplan-Meier (KM) curves and their median and confidence intervals will be estimated using KM estimates.
Measured: From the start date of treatment initation until the date of progression or death from any cause, whichever occurs first, assessed up to 1-year following autoSCT
Safety Outcome Measure
Evaluate the safety and tolerability as defined by CTCAE 5.0 criteria
Measured: Up to 30 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start8 Apr 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: No accrual of participants in 18 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Diffuse Large B-cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dipenkumar Modi, Barbara Ann Karmanos Cancer Institute
- Investigators
- Dipenkumar Modi, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222438
- Sponsor's protocol ID
- 2021-047
- Other IDs
- ADCT-402-001
- Status last verified
- Oct 2023
- First submitted
- 10 Jan 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Evaluating Safety and Efficacy of Loncastuximab Tesirine as a Maintenance Therapy Following Autologous Stem Cell Transplantation in High Risk Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05222438
- Acronym / sponsor ID
- 2021-047
- Conditions
- Relapsed Diffuse Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual of participants in 18 months
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 8 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Feb 2022 (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.
Study of loncastuximab tesirine administered intravenously (IV) for maintenance therapy following autologous stem cell transplant in patients with relapsed diffuse large B cell lymphoma
Detailed description
This is a Phase II, multicenter, open label study of loncastuximab tesirine for maintenance therapy following autologous stem cell transplant (autoSCT) in patients with relapsed diffuse large B cell lymphoma (DLBCL). Patients with relapsed DLBCL confirmed through core biopsy and meeting eligibility criteria will be enrolled in the study. Patients can be enrolled up to 4 weeks prior to autoSCT. Patients will start loncastuximab tesirine between day 30 and 60 after autoSCT as determined by the treating physician. Since majority of the relapses occur early after autoSCT, offering maintenance therapy for a finite duration might be of therapeutic benefit without posing excessive toxicity. Loncastuximab tesirine will be administered intravenously (IV) at every 3 weeks (Q3W) for a total of 6 months (8 cycles).
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 | Experimental | Drug: loncastuximab tesirinePatients will start loncastuximab tesirine for maintenance therapy between day 30 and 60 following autoSCT and will receive a total of 6 months of therapy (8 cycles). Patients will receive IV infusion of loncastuximab tesirine 150 μg/kg at Q3W for the first 2 cycles followed by 75 μg/kg at Q3W for the remaining 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed informed consent form (ICF)
- Age >18 years
- Patients with relapsed refractory DLBCL with any of the following high-risk features for progression following autoSCT will be enrolled:
- Eligible to undergo autologous stem cell transplantation as per local investigator assessment
- Availability of biopsy specimens confirming DLBCL relapse. Archival formalin-fixed paraffin-embedded (FFPE) tissue blocks or 15 unstained slides serial sections (5-10 μm in thickness) must be available prior to study enrollment. The pathology report must be available. IHC testing of CMYC, BCL2, and BCL6 expression, and FISH testing of CMYC, BCL2 and BCL6 gene rearrangement must be available prior to enrollment. CD19 expression status must be available prior to enrollment.
Key exclusion criteria (26 listed)
- Contraindications to any of the individual components of autoSCT or loncastuximab tesirine.
- Prior exposure to loncastuximab tesirine
- Clinically significant effusion i.e. ascites, pleural or pericardial effusion requiring drainage or associated with shortness of breath
- Patients with ongoing toxicities of grade >1 from previous treatments except alopecia
- Patients with clinically significant history of liver disease including cirrhosis or hepatitis (viral hepatitis). However, treated viral hepatitis may be allowed Patients with history of severe skin disorders including Steven-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
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 tesirineloncastuximab tesirine for maintenance therapy between day 30 and 60 following autoSCT and will receive a total of 6 months of therapy (8 cycles). | Drug | Loncastuximab tesirine |
Primary outcome
Efficacy Outcome Measure
Time frame: From the start date of treatment initation until the date of progression or death from any cause, whichever occurs first, assessed up to 1-year following autoSCT
Progression-free survival (PFS) assessments will be determined according to Lugano Response Criteria. The distributions of time to event data will be graphically summarized using Kaplan-Meier (KM) curves and their median and confidence intervals will be estimated using KM estimates.
Safety Outcome Measure
Time frame: Up to 30 days after last dose of study treatment
Evaluate the safety and tolerability as defined by CTCAE 5.0 criteria
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Related trials for Relapsed Diffuse Large B-cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 2/3
A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)
Lymphoma, Large B-Cell, Diffuse, Diffuse Large B-Cell Lymphoma
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.
Dipenkumar Modi, M.D. principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing loncastuximab tesirine in people with Relapsed Diffuse Large B-cell Lymphoma, run by Barbara Ann Karmanos Cancer Institute 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 20 inclusion and 26 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: withdrawn, as of the sponsor's last update on 1 Nov 2023. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy Outcome Measure (time frame: From the start date of treatment initation until the date of progression or death from any cause, whichever occurs first, assessed up to 1-year following autoSCT). 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 1 Nov 2023.