GPL in Patients with Relapsed/refractory Diffuse Large B Cell Lymphoma

NCT05335018 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: GPL
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, open-ended, single-arm, multicenter Phase II clinical trial. To evaluate the efficacy of Glofitamab, Poseltinib, and Lenalidomide combination therapy in patients with relapsed/refractory diffuse large B-cell lymphoma.

Conditions

Relapsed/refractory Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Efficacy evaluation of Gofitamab, Poseltinib, and Lenalidomide using endpoints

  Overall Response Rate according to Lugano criteria

  At the end of Cycle 2 (each cycle is 28 days)

Study Arms (1)

Treatment

EXPERIMENTAL

total 2years. Glofitamab: Increase from 2.5mg for 8days in 1 cycle to 10mg for 15days. 2cycles 1day 30mg, 30 mg on the 1st day of every week thereafter. Poseltinib: 40mg/day bid orally, administered daily from the 1st to the 21st of every week. Lenalidomide: 20mg/day bid orally, administered daily from the 1st to the 14st of every week.

Drug: Glofitamab, Poseltinib, Lenalidomide

Interventions

Glofitamab, Poseltinib, Lenalidomide DRUG

Glofitamab: Increase from 2.5mg for 8days in 1 cycle to 10mg for 15days. 2cycles 1day 30mg, 30 mg on the 1st day of every week thereafter. Poseltinib: 40mg/day bid orally, administered daily from the 1st to the 21st of every week. Lenalidomide: 20mg/day bid orally, administered daily from the 1st to the 14st of every week.

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female aged ≥19 years
• Histologically diagnosed with CD20-expressing B-cell NHL
• Diffuse large B-cell lymphoma (DLBCL)
• Transformed follicular lymphoma
• Relapse after or failure to respond to at least prior treatment regimen treatments and last dose administered must be more than 2-weeks ahead from enrollment
• Should have received anti-CD20 based chemotherapy previously
• Failed to at least two lines of therapy if patient is candidate for autologous stem cell transplantation
• Failed frontline therapy if patient is ineligible for autologous stem cell transplantation.
• ④Not eligible if patient's IHC expression is both BCL6(-) and MYC(+). However, in the salvage cohort group, subjects with previous pathological test results of BCL6(-) and MYC(+) may be eligible.
• ⑤Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension.
• ⑥Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
• ⑦Adequate liver, hematological and renal function.
• Total bilirubin ≤ 2 x ULN and AST, ALT ≤ 3 x ULN
• WBC ≥ 3,000 /μL, ANC ≥ 1,000 /μL, Platelets ≥ 75,000 /μL, and Hemoglobin ≥ 9.0 g/dL. (adjustment with blood transfusion \& G-CSF within 2 weeks is not allowed)
• Cr ≤ 1.5 x ULN or CLcr ≥ 30 mL/min (Cockcroft-Gault)

You may not qualify if:

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• Has previously received 4 or more lines of anticancer chemotherapies (autologous hematopoietic stem cell transplantation is considered as 1 line of treatment).
• Has current evidence or history of macrophage activation syndrome/hemophagocytic lymphohistiocytosis (MAS/HLH).
• Prior treatment with glofitamab.
• Has acute bacterial, viral, or fungal infections confirmed with positive blood culture or diagnosed clinically in case there is no positive blood culture.
• Has known active infection or reactivation of latent infection, regardless of bacteria, viruses, fungi, mycobacteria, or other pathogens, or has an episode of major infection requiring hospitalization or intravenous antibiotic treatment within 4 weeks from the dose of study drug.
• Has received systemic immunotherapy including a radioimmunoconjugate, an antibody-drug conjugate, or an immune checkpoint inhibitor (eg. anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA4\], anti-programmed death 1 \[anti-PD1\], and anti-programmed death ligand 1 \[anti-PDL1\]) within 4 weeks from the dose of study drug or within 5 half-lives of the drug.
• Has experienced treatment-emergent immune-related AE during previous immunotherapy.
• Has received radiotherapy, anticancer chemotherapy, or other experimental chemotherapy including chimeric antigen receptor therapy (CAR-T) within 4 weeks from the first dose of study drug.
• Has received a homologous hematopoietic stem cell transplantation within 1 year or has previously received a solid organ transplantation.
• Has received autologous hematopoietic stem cell transplantation within 100 days from the first dose of study drug.
• Has a graft-versus-host disease (GVHD) requiring treatment.
• Is not able to have oral intake of study drug.
• Has resistance to BTK inhibitors or lenalidomide (defined as PFS less than 6 months after BTK inhibitors or lenalidomide).
• Has previously been diagnosed with a malignancy other than the cancer included in this study, except appropriately treated basal cell carcinoma, squamous cell skin cancer, in situ cancer, and at least 5 years of disease free status from previous cancer.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

glofitamab; poseltinib; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sung-soo Yoon

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: hematology oncology Professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 19, 2022
• Study Start: May 30, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

KR (1)