BridgeMD
New treatment option for Large B-cell Lymphoma
Official title A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL
ClinicalTrials.gov ID: NCT06375733
What this study is testing
What is GFH009?
GFH009 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma.
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
- This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
- 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
- Age ≥ 18 years old.
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma...
- Relapse or refractory after receiving 2\~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.
- Must have a measurable lesion.
- The patient is not suitable to receive stem cell transplantation judged by the investigator.
You likely can't join if
- Primary or secondary central nervous system (CNS) lymphoma.
- Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational...
- Patients with primary resistance to CDK9 or BTK inhibitors.
- Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation...
- Other malignancies within 2 years prior to study entry, excluding appropriately treated carcinoma in situ of the cervix, focal squamous cell...
- Have significant diseases of the cardiovascular system or significant acute or chronic infection. History of stroke or intracranial hemorrhage within...
See the full eligibility criteria
- Age ≥ 18 years old.
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma...
- Relapse or refractory after receiving 2\~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.
- Must have a measurable lesion.
- The patient is not suitable to receive stem cell transplantation judged by the investigator.
- The Eastern Cooperative Oncology Group (ECOG) performance status score (PS) is 0\~2.
- Have adequate organ function, including: i. Hematopoietic function: absolute neutrophil count (ANC) ≥1.0×109/L, platelet count (PLT) ≥75×109/L and hemoglobin (Hgb) ≥ 80 g/L. ii. Liver function: total bilirubin ≤ 1.5 ×...
- Primary or secondary central nervous system (CNS) lymphoma.
- Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is...
- Patients with primary resistance to CDK9 or BTK inhibitors.
- Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation within 6 months.
- Other malignancies within 2 years prior to study entry, excluding appropriately treated carcinoma in situ of the cervix, focal squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring...
- Have significant diseases of the cardiovascular system or significant acute or chronic infection. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. Presence of significant...
- Has a history of bleeding disorder or a history of spontaneous bleeding requiring blood transfusion or other medical intervention. Active bleeding within 2 months prior to the first dose.
- Surgical procedures (excluding needle biopsies) that may affect the administration or study evaluation of this study within 28 days prior to the first dose.
- Patients who have been treated with prednisone (or equivalent doses of glucocorticoids) at \>20 mg/day for anti-tumor purposes within 7 days, or who require long-term use of glucocorticoids for non-anti-tumor therapy.
- Ongoing medical treatment with a potent inhibitor or inducer of CYP3A is required.
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, China
- Zhengzhou, 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 Nanning, China; Zhengzhou, 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.