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DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT06287398

Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL

A Phase 2 study testing Epcoritamab in people with DLBCL - Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Australasian Leukaemia and Lymphoma Group at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epcoritamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteAustralia
Study dates
11 Dec 2023to Nov 2031
Phase
Phase 2
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

  • Age 18 years or older
  • Confirmed diagnosis of DLBCL, Not-otherwise specified (NOS), Transformation of indolent B-cell lymphoma, High-grade B-cell lymphoma (HGBCL), NOS, Diffuse-large BCL (DLBCL)/ High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements or Follicular large B-cell lymphoma according to World Health Organization (WHO) 2016 or 2022 criteria that has relapsed or progressed after one line of chemoimmunotherapy
  • Transplant eligible according to local assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5cm in longest axis or an extranodal site greater than 1.0cm in longest axis AND baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) scans must demonstrate positive lesion compatible with CT defined anatomical tumour sites
  • Histological confirmation of tumour CD20 positivity, analysed by immunohistochemistry, on a pre-enrolment tissue sample performed after most recent prior therapy
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  • Adequate renal function
  • Creatinine clearance greater than 45mL per min (Cockcroft Gault formula)
  • Adequate hepatic function:
  • Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3x Upper Limit of Normal (ULN)
  • Bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) or less than or equal to 3 if documented liver involvement and/or Gilbert's disease.
  • Adequate haematologic function:
  • Haemoglobin greater than or equal to 90g/L (transfusion support permitted)
  • Absolute neutrophil count greater than or equal to 1.0 x 109 per L; growth factor support allowed in case of bone marrow involvement
  • Platelet count greater than 75 x 109 per L or greater than or equal to 50 x 109 per L if documented marrow involvement
  • Able to take oral medications
  • Adequate washout of prior therapies:
  • At least 4 weeks since last dose of immunochemotherapy, radio-conjugated or toxin-conjugated compound, or other investigational anti-cancer therapy
  • At least 6 weeks since chimeric antigen-receptor T-cell therapy
  • Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
  • If receiving glucocorticoid treatment at screening, treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of Epcoritamab
  • Before the first dose of Epcoritamab, during the trial and for 12 months after last administration of Epcoritamab, a woman must be either:
  • Not of childbearing potential, defined as: premenarchal; postmenopausal (greater than 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level greater than 40 IU per L or milli-International unit (mIU) per mL); permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • Of childbearing potential and practicing a highly effective method of birth control (as defined by the European Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials: e.g., established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner should be the sole partner for that patient); true abstinence (when this is in line with the preferred and usual lifestyle of the patient) * If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 16b
  • A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of Epcoritamab
  • Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of Epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of Epcoritamab
  • The patient understands the purpose of the trial and procedures required for the trial and is capable of giving signed informed consent which includes compliance with the requirements (no medical or psychiatric reason precluding participation) and restrictions listed in the informed consent form (ICF) and in this protocol

Who cannot join

  • Diagnosis of primary Central Nervous System (CNS) lymphoma
  • Active secondary CNS involvement of lymphoma at time of screening
  • A prior history of secondary CNS lymphoma is allowed provided that it has been successfully treated and there are no features of recurrence.
  • Prior autologous stem cell transplant
  • Known past or current malignancy other than inclusion diagnosis, except for:
  • Cervical carcinoma of Stage 1B or less.
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  • Non-invasive basal cell or squamous cell skin carcinoma.
  • Non-invasive, superficial bladder cancer.
  • Prostate cancer with a current Prostate Specific Agent (PSA) level less than 0.1 ng per mL e. indolent lymphoma
  • Indolent lymphoma
  • Other malignancy that has been treated with curative intent and has remained in remission for 2 years
  • Any prior therapy with a bispecific antibody targeting CD3 and CD20
  • Uncontrolled systemic infection
  • Known HIV infection
  • Known active hepatitis B or C infection based on criteria below:
  • Hepatitis B virus (HBV): Patients with positive HbsAg are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HbsAg require negative hepatitis B polymerase chain reaction (PCR) before enrolment and must be treated with antiviral therapy. Patients who are hepatitis B PCR positive will be excluded.
  • Hepatitis C virus (HCV): If positive hepatitis C antibody, patient will need to have a negative hepatitis C ribonucleic acid (RNA) before enrolment. Patients who are hepatitis C RNA positive will be excluded.
  • Seizure disorder, unless seizure-free for 12 months on established anticonvulsant therapy without the requirement for modification to anticonvulsants within the prior 12 months
  • Known clinically significant cardiac disease, including:
  • Onset of unstable angina pectoris within 6 months of signing the patient informed consent form (PICF)
  • Acute myocardial infarction within 6 months of signing the PICF
  • Congestive heart failure (grade III or IV as classified by the New York Heart Association
  • Decreased ejection fraction of less than 45%
  • Confirmed history or current autoimmune disease requiring permanent immunosuppressive therapy. Low-dose prednisolone (less than or equal to 10mg/day or equivalent) for rheumatoid arthritis or similar conditions is allowed.
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing PICF
  • Women who are pregnant or lactating.
  • Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Known hypersensitivity or adverse reaction to rituximab, tocilizumab or any elements of DHAOx
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Australia1 site, 1 recruiting

  • Australasian Leukemia and Lymphoma Group

    Melbourne, Victoria, 3121

    Naomi Sprigg, 0383739706, Naomi.Sprigg@allg.org.au

    Adrian Minson, MD

    Recruiting

Other trials in Australia

About this study

Official title: A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma

The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:

  • Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant?
  • Is consolidation epcoritamab after ASCT deliverable and safe?
  • Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?
  • Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.
Read more

Participants will undergo three phases in this trial:

  1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab
  2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.
  3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.
Being tested
Epcoritamab
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Follicular, Recurrence

What participants receive

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

  • EpcoritamabDrug

    Epcoritamab (Epcor) is a bispecific antibody recognizing the T-cell antigen CD3 and the B-cell antigen CD20. Epcor is a supplied as a concentrate for solution for intended subcutaneous injection. The dose must be prepared by a qualified pharmacist using aseptic technique.

    Epcoritamab-Salvage treatment phase:

    2-3 cycles of R-DHAOx therapy (rituximab, dexamethasone, cytarabine, oxaliplatin), given every 21 days combined with Epcoritamab subcutaneous weekly dosing (priming 0.16mg Cycle 1 Day 1, intermediate 0.8mg cycle 1 day 8, full dose 48mg from cycle 1 day 15 onwards)

    Epcoritamab Consolidation phase:

    6 cycles (28 days each) of subcutaneous Epcoritamab, commencing between 6-12 weeks post ASCT.

    Epcoritamab dosing and timing for consolidation:

    • Cycle 1 Day 1: Priming (0.16mg) dose
    • Cycle 1 Day 8: intermediate (0.8mg) dose
    • Cycle 1 Day 15: full dose 48mg
    • Cycle 1 Day 22, Cycle 2-3 Days 1, 8, 15 and 22: 48mg
    • Cycles 4 to 6 - Days 1 and 15 (fortnightly dosing): 48mg
Study groups in NCT06287398
Study groupRoleWhat they receive
Epcoritamab TreatmentExperimentalSingle arm study - All patients undergo same treatment with Epcoritamab for salvage and consolidation phases.
Receives: Drug: Epcoritamab

What is being measured

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

  1. Event-free survival (EFS)

    Time to event outcome measured in days from commencement of each treatment subset (salvage chemotherapy and Epcoritamab/ASCT/ Epcoritamab re-treatment) to date of first to occur out of reduced partial response (PR) after C2, commencement of non-protocolised cancer treatment, progression or death from any cause.

    Measured: 12 months

Secondary outcomes (5)

  1. Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT

    Rate of adverse events according to CTCAE criteria v 6.0 expressed as a number and proportion.

    Measured: From enrolment to 30 days after the final treatment is completed.

  2. Overall response rate (ORR)

    Defined as achievement of at least a partial response to treatment according to Lugano criteria i.e. achievement of a PR or CR at any time during study participation

    Measured: At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).

  3. Complete response rate (CRR)

    Defined as achievement of CR at any time during study according to Lugano criteria

    Measured: At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).

  4. Overall Survival (OS)

    Defined as the time from commencement of study treatment until death from any cause

    Measured: At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).

  5. Progression free survival (PFS)

    Defined as the time from commencement of study treatment until disease progression or death from any cause, following Epcoritamab-chemotherapy salvage, transplant and maintenance. Time to event outcome measured in months.

    Measured: At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).

Timeline

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

  1. First posted1 Mar 2024
  2. Study start11 Dec 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2031 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287398
Sponsor's protocol ID
NHL38
Status last verified
Jul 2024
First submitted
7 Feb 2024
Last updated
22 Jul 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual patient data will not be shared publicly. Aggregate patient data and final results will be presented in the final report.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab in people with DLBCL - Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Australasian Leukaemia and Lymphoma Group at 1 site in Australia.

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 27 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 22 Jul 2024. 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 Australia. 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (time frame: 12 months). 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 NCT06287398.

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 22 Jul 2024.

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