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Relapsed/Refractory Large B-Cell LymphomaPhase 2NCT06489808

Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL

A Phase 2 study testing Linperlisib, Rituximab and Gemcitabine in people with Relapsed/Refractory Large B-Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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

To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linperlisib, Rituximab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteChina
Study dates
28 May 2024to 31 May 2027
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

  • Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), follicular lymphoma grade 3B (FL, 3B), high-grade B-cell lymphoma unspecified (HGBCL, NOS), DLBCL/HGBCL with MYC and BCL2 rearrangements, FL transformed DLBCL without a previous history of indolent lymphoma.
  • Relapsed or refractory after first-line immunochemotherapy (which must include CD20 monoclonal antibody and anthracycline) 1)Refractory is defined as failure to achieve a complete response to first-line therapy (excluding patients who are intolerant to first-line therapy), including progressive disease (PD) as the best response to first-line therapy; stable disease (SD) as the best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP); partial response (PR) as the best response after at least 6 cycles of first-line therapy with biopsy-confirmed residual disease or disease progression within 12 months of initiating first-line therapy; complete response to first-line therapy followed by progression within 12 months after the end of therapy. 2)Relapse was defined as a complete response to first-line therapy followed by progression confirmed more than 12 months after the end of therapy.
  • Subjects must have at least 1 measurable lesion/evaluable lesion that meets the 2014 version of the Lugano Lymphoma Evaluation Criteria.
  • Subjects has no known or suspected central nervous system involvement by lymphoma.
  • Previous treatment with any antineoplastic therapy (including radiation therapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy) for which participation in this trial must have exceeded 2 weeks or 5 drug half-lives, whichever is shorter.
  • Age ≥ 18 years.
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  • ECOG score 0-2.
  • Expected survival ≥ 3 months.
  • Women of Childbearing Potential subjects must have a negative serum/urine pregnancy test within 7 days prior to the first dose; female subjects of childbearing potential and male subjects with partners of childbearing potential, as well as their partners, should agree to use effective contraception from signing the ICF until 6 months after the last dose of study drug.
  • Able to comply with the trial protocol as judged by the investigator.
  • Each subject (or legally acceptable representative) voluntarily joined the study and signed an informed consent form.
  • -

Who cannot join

  • Other malignancies within the last 5 years, except radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
  • Previous autologous or allogeneic hematopoietic stem cell transplantation.
  • History of Richter transformation.
  • Received > 1 line of systemic antineoplastic therapy.
  • Prior treatment with PI3K inhibitors.
  • Known hypersensitivity to trial products.
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  • Active viral, bacterial, or fungal infection requiring treatment (eg, pneumonia, etc.).
  • Requiring prolonged systemic hormones (at doses equivalent to > 10 mg prednisone/day) or any other form of immunosuppressive therapy. Subjects taking inhaled or topical corticosteroids may be enrolled.
  • Concomitant diseases and medical history:
  • Multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, ileus, etc.).
  • Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders.
  • Subjects with any severe and/or uncontrolled disease including:
  • 1)Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg). 2)Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 450 ms (male), QTc ≥ 470 ms (female)) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification). 3)Active interstitial pneumonia or other chronic lung disease resulting in severely impaired lung function defined as FEV1 and DLCOc < 60% of predicted normal; history of interstitial pneumonia due to COVID-19. 4)Abnormal liver: I.Decompensated cirrhosis (Child-Pugh class B or C). II.Known history of clinically significant liver disease. 5)Renal failure requiring hemodialysis or peritoneal dialysis. 6)Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 7)Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein quantification > 1.0 g.
  • Patients with active or history of autoimmune diseases that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk. Patients with autoimmune hypothyroidism requiring only hormone replacement therapy may be considered for enrollment if the disease is stable as assessed by the investigator.
  • Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
  • Positive pregnancy test at baseline in female patients who are pregnant, lactating, or of childbearing potential.
  • Concurrent medical conditions that, in the investigator 's judgment, would seriously compromise the patient' s safety or the patient 's completion of the study.
  • -

Trial locations and contacts

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

Wei Liu, MD contact

+86 022-23608463

liuwei@ihcams.ac.cn

Lugui Qiu, MD contact

+86 022-23908461

qiulg@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Disease Hospital

    Tianjin, Tianjin Municipality, 300020

    Wei Liu, MD, 86-022-23908463, liuwei@ihcams.ac.cn

    Wei Liu, MD

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, Multi-cohort Clinical Study of Linperlisib Combined With Standard Immunochemotherapy in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Failing to First-line Therapy

To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.

Read the detailed description

This is a phase 2, open-label, multicenter, multi-cohort study evaluating the efficacy and safety of Linperlisib combined with standard immunochemotherapy in the treatment of relapsed/refractory LBCL after first-line treatment. This study is divided into a safety run-in phase and a dose expansion phase.The primary objective of the safety run-in phase was to determine the recommended dose for the dose expansion phase based on dose-limiting toxicities (DLTs).

The dose expansion phase consisted of Cohort 1 and Cohort 2.Cohort 1 was transplant-ineligible patients who received Linperlisib in combination with R-Gemox at RP2D for 6 cycles.Cohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib combined with R-ICE/DHAP/GVM regimen, followed by autologous hematopoietic stem cell transplantation in responding patients

Being tested
Linperlisib, Rituximab, Gemcitabine, Oxaliplatin, Ifosfamide
Keywords
Linperlisib, Immunochemotherapy
Medical subject headings
Recurrence

What participants receive

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

  • LinperlisibDrug

    Linperlisib RP2D D1-14

  • RituximabDrug

    rituximab 375 mg/m2 D0

  • GemcitabineDrug

    gemcitabine per regimen dosage

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m2 D1

  • IfosfamideDrug

    Ifosfamide 5g/m2 D2

  • CarboplatinDrug

    Carboplatin AUC=5mg/mL · min (maximum absolute dose/cycle = 800 mg)

  • EtoposideDrug

    Etoposide 100mg/m2 D1-3

  • DexamethasoneDrug

    Dexamethasone 40mg D1-4

  • CisplatinDrug

    Cisplatin 100mg/m2 D1, continuous intravenous infusion

  • Ara-CDrug

    Ara-C 2g/m2 q12h D2

  • VinorelbineDrug

    Vinorelbine 20mg/m2 D1

  • Mitoxantrone hydrochloride liposomeDrug

    Mitoxantrone hydrochloride liposome 18mg/m2 D1

Study groups in NCT06489808
Study groupRoleWhat they receive
Cohort 1 transplant-ineligible patients: Linperlisib combined with R-Gemox regimenExperimentalCohort 1 consisted of transplant-ineligible patients who received Linperlisib in combination with R-Gemox. The treatment regimen was as follows: Linperlisib (RP2D dosage) on Days 1-14, rituximab 375 mg/m² on Day 0, gemcitabine 1000 mg/m² on Day 1, and oxaliplatin 130 mg/m² on Day 1, every 21 days for 6 cycles.
Receives: Drug: Linperlisib; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin
Cohort 2 patients scheduled for transplantation:Linperlisib combined with R-ICE/DHAP/GVM regimensExperimentalCohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib (RP2D, D1-14) combined with R-ICE/DHAP/GVM regimen (R-ICE regimen: rituximab, ifosfamide, carboplatin, etoposide; R-DHAP regimen: rituximab, cytarabine, dexamethasone, cisplatin; R-GVM regimen: rituximab, gemcitabine, vinorelbine, mitoxantrone liposome), followed by autologous hematopoietic stem cell transplantation in responding patients.
Receives: Drug: Linperlisib; Drug: Rituximab; Drug: Gemcitabine; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: Dexamethasone; Drug: Cisplatin; Drug: Ara-C; Drug: Vinorelbine; Drug: Mitoxantrone hydrochloride liposome

What is being measured

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

  1. Dose-Limiting Toxicities

    Dose-Limiting Toxicities per study protocol defination

    Measured: Safety Run-in Period, up to the end of cycle 1 (each cycle is 21 days)

  2. ORR

    Response is assessed according to the Lugano criteria

    Measured: up to 2 years

Secondary outcomes (6)

  1. Incidence of Treatment-Emergent Adverse Events

    The adverse events were evaluated by NCI-CTCAE 5.0 standard Hematologic and non-hematologic toxicity

    Measured: up to 2 years

  2. Complete Response Rate (CRR)

    Response is assessed according to the Lugano criteria

    Measured: up to 2 years

  3. Duration of Response (DOR)

    From the date of achieving complete or partial response until disease progression, death or last follow-up

    Measured: up to 2 years

  4. Duration of Complete Response (DOCR)

    From the date of achieving complete response until disease progression, death or last follow-up

    Measured: up to 2 years

  5. Progression-free Survival (PFS)

    From the date of the first dose of therapy is given until disease progression, death or last follow-up

    Measured: up to 2 years

  6. Overall Survival (OS)

    From the date of the first dose of therapy is given until death, irrespective of cause

    Measured: up to 2 years

Timeline

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

  1. First posted8 Jul 2024
  2. Study start28 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
89 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06489808
Sponsor's protocol ID
IIT2024030
Status last verified
May 2024
First submitted
28 Jun 2024
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Linperlisib, Rituximab and Gemcitabine in people with Relapsed/Refractory Large B-Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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 12 inclusion and 18 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 8 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 China. 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?

Contact Wei Liu, MD (+86 022-23608463, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities (time frame: Safety Run-in Period, up to the end of cycle 1 (each cycle is 21 days)). 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?

On the ClinicalTrials.gov record for NCT06489808.

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 8 Jul 2024.

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