Actively Recruiting
Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
Led by Fifth Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-03-06
28
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 conditioning regimen. The study plans to include 28 patients who received the TCCA regimen for pre-transplantation pretreatment before auto-HSCT. Maintenance treatment will be carried out after transplantation for 1 year to observe the efficacy and safety.
CONDITIONS
Official Title
Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form themselves
- Confirmed diagnosis of acute lymphoblastic leukemia (ALL) by bone marrow cell morphology, immunology, and genetics
- PH+ALL patients who achieve early molecular remission (s3CMR) within 3 months and maintain remission
- PH-B-ALL patients who reach MRD- after 3 chemotherapy courses and continue MRD-
- Adult patients with Burkitt lymphoma and lymphoblastic lymphoma confirmed by histopathology and molecular genetics
- Adult Burkitt lymphoma and lymphoblastic lymphoma patients with non-involved bone marrow achieving partial remission or better after induction
- If bone marrow was involved at diagnosis, patients must achieve MRD- after 3 chemotherapy courses and maintain MRD-
- Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT)
- Age between 18 and 65 years, male or female
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2
You will not qualify if you...
- History of cancer and treatment for this tumor within the past 3 years, except superficial bladder cancer, skin basal or squamous cell carcinoma, cervical intraepithelial carcinoma, or prostate epithelium internal carcinogenesis
- Known seropositivity for HIV, active hepatitis B or C, or syphilis
- Mental illness or conditions preventing cooperation with treatment and monitoring
- Pregnancy or inability to use appropriate contraception during treatment
- Received hematopoietic stem cell transplantation within the past 1 year
- Active heart disease including uncontrolled angina, recent myocardial infarction (less than 6 months), severe arrhythmia, uncontrolled congestive heart failure, or low ejection fraction
- Planned major surgery within 4 weeks before enrollment or during the study, or unhealed surgical wounds
- Received live vaccines within 4 weeks before enrollment
- Suspected active or latent tuberculosis
- Participation in other clinical trials within 1 month before enrollment
- Any condition deemed unsuitable for enrollment by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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