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New treatment option for Diffuse Large B-Cell Lymphoma-Recurrent
Official title Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL
ClinicalTrials.gov ID: NCT06570447
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diffuse large b-cell lymphoma-recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- To be eligible for enrollment in this study, a subject must meet all of the following criteria:
- Signed informed consent
- Age ≥ 18 years at the time of informed consent
- Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients...
- Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis...
You likely can't join if
- Any subject who meets any of the following criteria should not be enrolled in the study:
- Inability to comply with protocol-specified hospitalization and restrictions
- Richter's transformation
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major...
- Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)
- Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen [HBsAg] serology). \- Patients...
See the full eligibility criteria
Who can join
- \- To be eligible for enrollment in this study, a subject must meet all of the following criteria:
- Signed informed consent
- Age ≥ 18 years at the time of informed consent
- 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.
- 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...
- 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...
- 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.
- Patients must have measurable disease: at least one bidimensionally measurable Lymphadenopathy, defined as \> 1.5 cm in the longest diameter; or at least one bidimensionally measurable extranodal lesion, defined as \>...
- Verify availability of Neoplasm tissues, unless not available per investigator assessment. Freshly collected Biopsy specimens are preferred. Representative Neoplasm tissue specimens or unstained serial sections are...
- Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1
- Life expectancy (as assessed by the investigator) ≥ 12 weeks
- Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia).
- Adequate liver function
- Bilirubin total ≤ 1.5 x upper limit of normal (ULN); patients with documented history of Gilbert's syndrome: Bilirubin total ≤ 3 x ULN with elevated indirect Bilirubin;
- AST/ALT ≤ 3 × ULN
- Adequate hematological function:
- Neutrophil count ≥ 1.5 x 109 cells/L (1.500/μL);
- Platelet count ≥ 75,000/μL (and no Platelet transfusion within 14 days before Gpt administration on Day 1 of Cycle 1);
- Haemoglobin ≥ 10.0 g/dL (6.2 mmol/L); no Transfusion within 21 days prior to Gpt dosing on Cycle 1 Day 1
- Adequate renal function: Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL/min calculated according to the C OC kroft Gault formula (see Appendix 14) (patients whose renal function is not adequately reflected...
- Negative serum Pregnancy test within 7 days prior to study treatment for women of childbearing potential. Amenorrhoea is not required for women of non-childbearing potential who are post-menopausal (≥ 12 months of...
- For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception
What rules you out
- Any subject who meets any of the following criteria should not be enrolled in the study:
- Inability to comply with protocol-specified hospitalization and restrictions
- Richter's transformation
- 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...
- Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)
- 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...
- 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.
- Known HIV seropositive status \- For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.
- Known or suspected chronic active Epstein-Barr Viral infection
- Known or suspected history of Haemophagocytic lymphohistiocytosis (H LH)
- Pregnancy or lactating, or planning to Pregnancy during treatment and for at least 3 months after the last dose of Gpt or within 2 months after the last dose of Glofitamab
- A history of treatment-emergent Immunization related Immunization associated with prior Adverse event treatment agents as follows:
- Grade 3 Adverse event, except for Grade 3 endocrinopathy managed with alternative therapy
- Grade 1-2 Adverse event that did not return to baseline after Therapy cessation
- Documented refractory to Obinutuzumab monotherapy
- Active autoimmune disease requiring treatment requires investigator assessment of Immunization
- Evidence of significant, uncontrolled concomitant disease that could affect adherence to the study protocol or interpretation of results, including Immunization, relevant Lung disorder history (Bronchospasm, Obstruction...
- History of severe Allergy or Allergic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion Protein)
- History of confirmed progressive multifocal Leukoencephalopathy (PML)
- Current or past history of CNS Lymphoma
- Current or past history of CNS disease such as Stroke, Epilepsy, CNS Vasculitis, or neurodegenerative disease
- Another invasive Neoplasm malignant within the last 2 years (except Basal cell carcinoma and Neoplasm with a low likelihood of recurrence)
- Serious or extensive Angina unstable such as New York Heart disorder Association Class III or IV or objectively assessed Class C or D Cardiac disorder, Myocardial infarction within the last 6 months, unstable...
- Administration of a live attenuated vaccine within 4 weeks prior to Gpt infusion, or anticipated need for a live attenuated vaccine during the study. ( Note: Flu vaccination should only be administered during the Flu...
- Systemic Tumour necrosis agents (including but not limited to Cap Phosphorus amide, thiazolyl Purines, methotrexate, thalidomide, and anti Ammonia factor agents) within 2 weeks prior to Gpt infusions
- Corticosteroid therapy with ≤ 25 mg/day prednisone or equivalent is allowed.
- Inhaled and topical steroids are allowed.
- History of illicit drugs or Alcohol abuse within 12 months prior to screening, as judged by the investigators.
- Any other disease, metabolic dysfunction, Physical examination result, or clinical lab result reasonably suspecting a disease or condition that contraindicates the use of an investigational drug
- Investigators should review the Vaccination status of potential study patients considered for this study and follow local disease control and prevention guidelines for vaccination of any other non-live vaccinated adults...
- Any mental or Cognitive disorder that would limit the understanding, conduct, and compliance with the informed consent form;
- Pregnancy or lactating females, or females or male partners planning to Pregnancy during the study;
- Other situations that the investigators consider Discomfort to be eligible for this trial
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.