Status:
RECRUITING
Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Burkitt Lymphoma
Lymphoblastic Lymphoma, Adult
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is an observational study on the efficacy and safety of auto-HSCT in adult patients with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia who received TCCA conditi...
Eligibility Criteria
Inclusion
- 1\. Voluntarily sign the informed consent form, which must be signed by the patient himself.
- 2\. ALL patients confirmed by bone marrow cell morphology, immunology, and genetics; 3. PH+ALL patients who achieve s3CMR (definition: achieve molecular biological remission in the early stage of initial treatment (within 3 months) and maintain remission); 4. Ph-B-ALL patients who have reached MRD- after 3 courses of chemotherapy and continue to be MRD-; adult patients with Burkitt lymphoma and lymphoblastic lymphoma confirmed by histopathology and molecular genetics; 5. Adult patients with Burkitt lymphoma and lymphoblastoma, if the bone marrow is not involved, can achieve PR or above after induction; if the bone marrow is involved at the time of initial diagnosis, 3 courses of chemotherapy are required to reach MRD- and continue to be MRD-.
- 6\. Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT); 7. Age ≥18 years and ≤65 years old, male or female; 8. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2;
Exclusion
- 1\. Have a history of cancer and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN), or prostate epithelium Internal carcinogenesis (PIN); 2. Known to be serologically positive for HIV, active hepatitis B, active hepatitis C virus or syphilis; 3. Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring; 4. Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 5. Received hematopoietic stem cell transplantation within the past 1 year; 6. Active heart disease, defined as one or more of the following:
- Have a history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months from study enrollment;
- Have a history of arrhythmia that requires drug treatment or has severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\>NYHA class 2);
- The ejection fraction is lower than the lower limit of the normal range. 7. Patients who meet the following criteria:
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- Major surgery (except diagnostic surgery) is planned within 4 weeks before enrollment or during the study period, or the surgical wound has not fully healed before enrollment;
- Those who have received (attenuated) live vaccines within 4 weeks before enrollment;
- Patients with suspected active or latent tuberculosis;
- Participate in other clinical trials one month before enrollment 8. Those who the researcher believes are not suitable for enrollment
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06060782
Start Date
March 6 2024
End Date
December 31 2026
Last Update
March 6 2025
Active Locations (1)
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1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000