Health TrialsbyHealthPanel

Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL

ConditionRelapsed/Refractory Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Linperlisib

    Drug

    Linperlisib RP2D D1-14

  • Rituximab

    Drug

    rituximab 375 mg/m2 D0

  • Gemcitabine

    Drug

    gemcitabine per regimen dosage

  • Oxaliplatin

    Drug

    Oxaliplatin 130 mg/m2 D1

  • Ifosfamide

    Drug

    Ifosfamide 5g/m2 D2

  • Carboplatin

    Drug

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

  • Etoposide

    Drug

    Etoposide 100mg/m2 D1-3

  • Dexamethasone

    Drug

    Dexamethasone 40mg D1-4

  • Cisplatin

    Drug

    Cisplatin 100mg/m2 D1, continuous intravenous infusion

  • Ara-C

    Drug

    Ara-C 2g/m2 q12h D2

  • Vinorelbine

    Drug

    Vinorelbine 20mg/m2 D1

  • Mitoxantrone hydrochloride liposome

    Drug

    Mitoxantrone hydrochloride liposome 18mg/m2 D1

Treatment groups

89 Participants
are divided into 2 treatment groups
Group A: Cohort 1 transplant-ineligible patients: Linperlisib combined with R-Gemox regimenExperimental treatment 4 interventions
Group B: Cohort 2 patients scheduled for transplantation:Linperlisib combined with R-ICE/DHAP/GVM regimensExperimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicities

Dose-Limiting Toxicities per study protocol defination

Time frame
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

Time frame
up to 2 years

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events

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

Time frame
up to 2 years
2

Complete Response Rate (CRR)

Response is assessed according to the Lugano criteria

Time frame
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

Time frame
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

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
Apply now