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Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma

NCT06570447•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Detailed Description

This is an open-label, single-arm, single-center study to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in the patient ≥ 18 years of age with recurrent/refractory diffuse large B-cell lymphoma. Subjects who meet the eligibility criteria will receive combination therapy of Glofitamab, chidamide. The study will include the following sequential phases: screening, treatment, and follow-up.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- To be eligible for enrollment in this study, a subject must meet all of the following criteria:
•1. Signed informed consent
•2. Age ≥ 18 years at the time of informed consent
•3. Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures.
•4. Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL)
•\- A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if performed).
•5. Patients must have relapsed or Cap following at least two prior lines of systemic therapy (including at least one prior regimen containing anthracene Treatment failure and at least one prior regimen containing anti-CD20 targeted therapy).
•* Patients may have received Autologous haematopoietic stem cell transplant (HSCT) prior to recruitment; consolidative autologous HSCT after Chemotherapy will be counted as a line of therapy.
•* CAR T cells plus bridging were counted as a treatment line.
•* Local therapies (e.g., radiotherapy) will not be considered as treatment lines.
+15 more criteria

Exclusion Criteria

•Any subject who meets any of the following criteria should not be enrolled in the study:
•1. Inability to comply with protocol-specified hospitalization and restrictions
•2. Richter's transformation
•3. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major Infection (as evaluated by the investigators) within 4 weeks prior to first study treatment Contacts and Locations
•4. Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)
•5. Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen \[HBsAg\] serology).
•\- Patients with occult or previous HBV Infection (defined as HBsAg negative and Hepatitis B core antibody \[HBcAb\] positive) may be included if HBV DNA is undetectable, provided they are willing to undergo HBV DNA testing monthly during study treatment (or on Day 1 of each cycle) and monthly for at least 12 months after the last cycle, and are willing to receive appropriate antiviral therapy.
•6. Positive Hepatitis C virus (HCV) Antibody test
•\- Patients with HCV Polymerase chain reaction are eligible only if the PCR (Antibody positive) is negative for HCV RNA.
•7. Known HIV seropositive status
+26 more criteria

Locations (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 15, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2028

Last Updated

March 13, 2025

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-Cell Lymphoma-RecurrentDiffuse Large B-Cell Lymphoma-Refractory

Interventions

Glofitamab

DRUG

Chidamide

DRUG

Contacts

Huilai Zhang

CONTACT

+86-18622221228 huilaizhangtz@163.com