T-cell large granular lymphocytic leukemia
Conditions
Interventions
Single-arm Group:Bendamustine 70 mg/m^2, once daily via intravenous infusion for 2 consecutive days per cycle
every 28 days one cycle, total of 6 cycles (initial dose 50 mg/m^2 for patients aged >=70 years)
Sponsors
Jiangsu Province Hospital (the First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
15 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. 18 years <= age <= 85 years; 2. Diagnosed with T-LGLL based on a combination of morphology, multi-color flow cytometry, and molecular methods; 3. Failed to respond or relapsed after at least two prior lines of therapy for T-LGLL; 4. Cytopenia in at least one lineage: absolute neutrophil count < 500/µL; or hemoglobin < 10 g/dL or requiring red blood cell transfusion; or platelet count < 50 × 10^9/L; 5. ECOG performance status 0-2; 6. Understood and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Reactive large granular lymphocyte proliferation; 2. Prior treatment with bendamustine; 3. Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or during the follow-up phase of an interventional study; 4. Known history of primary immunodeficiency; 5. Known active tuberculosis; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Known allergy to any component of the study drug; 8. Uncontrolled concurrent comorbidities including, but not limited to: (1) Active or poorly controlled severe infection; (2) Symptomatic congestive heart failure (New York Heart Association class III-IV) or symptomatic or poorly controlled cardiac arrhythmia; (3) Arterial hypertension that remains uncontrolled despite standard medical management (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg); (4) Any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to study enrollment; (5) Any life-threatening bleeding event or Grade 3 or 4 gastrointestinal/variceal bleeding requiring blood transfusion, endoscopic intervention, or surgical intervention within 3 months prior to study enrollment; (6) History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to study enrollment (thrombosis associated with an implantable venous access port or catheter, or superficial vein thrombosis, are not considered serious thromboembolism); (7) Intestinal obstruction, or history of inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; (8) Other acute or chronic medical or psychiatric conditions, or laboratory abnormalities that may increase the risks associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient ineligible for the study; 9. Known human immunodeficiency virus (HIV) infection, active hepatitis B (HbsAg positive, or HbsAg negative with HbcAb positive and HBV DNA positive), or hepatitis C virus infection (positive result by polymerase chain reaction [PCR]); 10. History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment; 11. Known interstitial lung disease; 12. Clinically uncontrolled third-space fluid accumulation, such as pleural effusion or ascites not controllable by drainage or other means prior to enrollment; 13. History of other primary malignancies, except: (1) Malignancy treated with curative intent, with no known active disease for >= 5 years prior to enrollment and a low risk of recurrence; (2) Non-melanoma skin cancer or lentigo maligna adequately treated with no evidence of disease recurrence; (3) Carcinoma in situ adequately treated with no evidence of disease recurrence; 14. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR) Rate;Objective Response Rate (ORR) and Complete Response (CR) Rate;Time to Response;Molecular Remission Rate in Bone Marrow and Peripheral Blood (TCR Rearrangement Negative);Flow Cytometry-Based MRD-Negative Rate in Bone Marrow and Peripheral Blood;Progression-Free Survival (PFS) and Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital (the First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed