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ZSDT for the treatment of recurrent refractory mantle cell lymphoma after BTK inhibitor failure: a multi-center prospective clinical trial

ZSDT for the treatment of recurrent refractory mantle cell lymphoma after BTK inhibitor failure: a multi-center prospective clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106604
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-07-31
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Mantle cell lymphoma

Interventions

Experimental group:ZSDT(Zuberitamab+Selinexor+Dexamethasone+Thalidomide)

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1:   1.Ages 18-70, ECOG score 0-2(including ages 18 and 70) 2:   2.Overall Survival > 6 months 3:   3.The diagnosis of mantle cell lymphoma was confirmed by histopathology. 4.At least one measurable lesion 4:   5.Acceptable hematologic parameters, no contraindications to chemotherapy, absolute neutrophil >= 1.0 × 10 ^ 9 L, platelet >= 75 × 10 ^ 9 L, hemoglobin >= 80 g/L (except for patients with bone marrow infiltration) , 6.Liver function: direct bilirubin <= 1.5 × upper limit , Alanine transaminase or aspartate transaminase <= 2.5 × upper limit , Alkaline phosphatase<= 3 × ULN in patients without non-bone involvement, 7.Renal function: serum creatinine <= 1.5 ×ULN 5:   8.Women of Childbearing Potential (WOBCP) or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF and WOBCP must undergo a serum pregnancy test within seven days before the first medication and the results are negative. 9.Recurrent refractory patients after BTK inhibitor treatment, 10. The subjects voluntarily partici;

Exclusion criteria

Exclusion criteria:  1.Refusing to take blood samples 2:   2. Previous allergies to any of the medications in the regimen 3:   3. Pregnant and lactating women 4. The researchers believe that major diseases can cause interference in the trial. 5. Combined with other tumors. 6. There are drug-related contraindications to treatment in the protocol 4:   7. People with severe mental illness 5:   8. Participating in other clinical trials 6:   9. Any severe or uncontrolled systematic disease, such as: uncontrolled diabetes 7:   severe heart failure (NYHA Class II or higher) 8:   acute coronary syndrome in the last 6 months 9:   Coronary revascularization, such as stent implantation, coronary artery bypass grafting, and other heart and large vessel related procedures performed within the last 6 months 10:   severe arrhythmias include frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation atrial flutter, and severe bradycardia. Uncontrolled hypertension: systolic pressure > 180 mmHg and/or diastolic pressure >100 mmHg;

Design outcomes

Primary

MeasureTime frame
Complete response rate, CRR;

Countries

China

Contacts

Public ContactXudong Zhang

The First Affiliated Hospital of Zhengzhou University

fcczhangxd@zzu.edu.cn+86 371 6627 9567

Outcome results

None listed

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