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New treatment option for Diffuse Large B-Cell Lymphoma
Official title DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)
ClinicalTrials.gov ID: NCT07059650
What this study is testing
What is DZD8586+R-CHOP?
DZD8586+R-CHOP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse 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 study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events.
- 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
- Cohort 1:
- Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.
- Disease stage II to IV by Ann Arbor Classification.
- Life expectancy ≥ 12 months.
- Cohort 2, 3:
You likely can't join if
- Cohort 2, 3: a. Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose. Radiation therapy within...
- All patients should not be included in this study if they have any of the following conditions:
- Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2...
- Prior use of BTK inhibitors.
- Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
- Currently taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to...
See the full eligibility criteria
- Cohort 1:
- Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.
- Disease stage II to IV by Ann Arbor Classification.
- Life expectancy ≥ 12 months.
- Cohort 2, 3:
- Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).
- Relapsed or refractory to first-line R-CHOP-like regimen.
- For patients who have received only one line of therapy, if the patient has not received autologous stem cell transplantation, the investigator needs to assess as unsuitable or the patient refuses intensive chemotherapy...
- Life expectancy ≥ 6 months.
- Patients must also meet all of the following criteria to be included in this study:
- All patients must provide a signed and dated written informed consent prior to any study-specific procedure, sampling, and analysis.
- Patients must be ≥ 18 years of age at the time of informed consent.
- ECOG status score of 0 to 2.
- Presence of at least one radiologically measurable lesion in 2 perpendicular directions as assessed by CT or MRI and a positive lesion on PET/CT scan consistent with a tumor site identified by CT or MRI.
- Adequate bone marrow hematopoietic reserve and organ function.
- No uncontrolled medical complications.
- Patients should be able to follow the relevant requirements of this study for medication and follow-up.
- Willing to comply with contraceptive restrictions.
- Cohort 2, 3: a. Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose. Radiation therapy within 14 days prior to first dose. Chemotherapy and small-molecule targeted...
- All patients should not be included in this study if they have any of the following conditions:
- Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.
- Prior use of BTK inhibitors.
- Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
- Currently taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, proton pump inhibitor...
- Major surgery within 4 weeks or anticipated surgery after the start of this study. Or insufficiently recovered from any toxicity and/or complications of previous intervention.
- Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- Active infectious diseases.
- Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate...
- The patient has been diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.
- Patients with hypersensitivity to DZD8586 drug excipients or other chemical analogues.
- Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.
- Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Hefei, China
- Linyi, China
- Taiyuan, China
- Wuhan, China
- Xi'an, 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 Beijing, China; Changsha, China; Chengdu, China; Guangzhou, China; Hangzhou, China; Hefei, China and 5 more location(s). 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.