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Single center, open, non randomized, single arm clinical trial of daretouximab and venetoclax combined with cage regimen in the treatment of refractory / recurrent adult T-lymphoblastic leukemia / lymphoma

Single center, open, non randomized, single arm clinical trial of daretouximab and venetoclax combined with cage regimen in the treatment of refractory / recurrent adult T-lymphoblastic leukemia / lymphoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058095
Enrollment
Unknown
Registered
2022-03-29
Start date
2022-03-18
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Refractory / recurrent adult T lymphoblastic leukemia / lymphoma

Interventions

experimental group:CAGE regimen with daletuzumab and Venetoclax

Sponsors

Beijing Boren Hospital Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Refractory/relapsed T-lymphoblastic leukemia/lymphoma was diagnosed as patients who failed, progressed or relapsed after treatment with standard regiments (including standard first-line and second-line therapy and high-dose chemotherapy); Patients with recurrence after autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation; 2. Patients aged 18-75 years (including 18 years), no gender limit; 3. No severe allergy; 4. Physical condition score 0-3; 5. Estimated survival >=90 days; 6. Immunohistochemistry or flow cytometry of tumor tissue indicated positive CD38 antigen; 7. The patient signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or cerebral disturbance of consciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Symptoms of severe respiratory failure; 4. With other types of malignant tumors; 5. Diffuse vascular intravascular coagulation; 6. Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7. Suffering from sepsis or other hard-to-control infections; 8. Severe mental disorder; 9. Have received organ transplantation (excluding autologous hematopoietic stem cell transplantation and allogeneic hematopoietic stem cell transplantation); 10. Positive HCG in the blood of female patients (patients with fertility); 11. Active hepatitis (including hepatitis B DNA and hepatitis C RNA copy number positive) and HIV/AIDS, syphilis positive screening.

Design outcomes

Primary

MeasureTime frame
Incidence and severity of adverse events;—

Secondary

MeasureTime frame
Objective response rate (ORR);Complete remission;Partial remission;Progression-free survival;Overall survival;Time to progression;Duration of response;—

Countries

China

Contacts

Public ContactHu Kai
bjbrgcpll@gobroadhealthcare.com+86 15010390336

Outcome results

None listed

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