Skip to content

Clinical Study on the BTKi Plus XPO1i Combined with RGemOx Regimen for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Clinical Study on the BTKi Plus XPO1i Combined with RGemOx Regimen for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104212
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-06-16
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Experimental group:None

Sponsors

Baotou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Refractory or relapsed DLBCL with clear pathology 2. Age 18~80 years old; 3. At least one measurable lesion on imaging, at least 15mm measurable lesion; 4. ECOG score is 0~2 points; 5. Expected survival time>=6 months; 6. Adequate organ function: cardiac ejection fraction >=50%, serum creatinine clearance rate >=30 mL/min, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =8 g/dL, platelet count >=75×10^9/L, absolute neutrophil >=1.0×10^9/L, if accompanied by bone marrow invasion, blood >=50×10^9/L, absolute neutrophil >=0.75×10^9/L. 8. Study participants of childbearing or childbearing potential must be willing to practice birth control from the date of enrollment in this study until the study follow-up period

Exclusion criteria

Exclusion criteria: 1. Major surgery or unhealed wounds and ulcers within 4 weeks before treatment (except for biopsies related to lymphoma diagnosis); 2. Diagnosis of primary mediastinal lymphoma or primary central nervous system lymphoma or high-grade B-cell lymphoma; 3. Previous history of indolent lymphoma; 4. History of intracranial hemorrhage in the past 6 months, requiring or receiving anticoagulation therapy with warfarin or equivalent antagonists; 5. Need to be treated with strong/medium CYP3A inducers or inhibitors; 6. Uncontrolled intercurrent illness including, but not limited to: symptomatic congestive heart failure (New York Heart Association class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease; 7. HIV infection and/or active hepatitis B or C; 8. Uncontrolled systemic infection; 9. The patient has contraindications to any of the drugs involved in the study protocol; 10. Pregnant or lactating women; 11. The underlying condition of the patient, in the judgment of the investigators, may increase their risk of receiving the study drug or confound their judgment of toxicity; 12. Inability to understand or follow the study protocol.

Design outcomes

Primary

MeasureTime frame
Response adaptability;Complete remission rate at the end of treatment;

Secondary

MeasureTime frame
Progression-free survival (PFS);Objective response rate (ORR) at end of treatment;

Countries

China

Contacts

Public ContactWang Yalan

Baotou Cancer Hospital

wxzhongguore@126.com+86 135 1489 6506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026