Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFifth Affiliated Hospital, Sun Yat-Sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Voluntarily sign the informed consent form, which must be signed by the patient himself.
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen
DrugAll enrolled patients received TCCA conditioning regimen（） before auto-HSCT: Thiotepa 5mg/kg, -8, -7 days Cyclophosphamide 40mg/kg, -6, -5 days Cladribine 5mg/m2, -4, -3, -2 days Cytarabine 2g/m2, -4, -3, -2 days
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: subject groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-year recurrence-free survival rate
Time frame
3 years after transplantationSecondary outcomes
1
3-year overall survival rate
Time frame
3 years after transplantation2
3-year recurrence rate
Time frame
3 years after transplantation3
Transplant-related mortality
Time frame
From the beginning of conditioning to 3 years after transplantation4
The patient's tolerance and mucositis grade
Time frame
From the beginning of conditioning chemotherapy to hematopoietic reconstitutionSponsors and contacts
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Source ClinicalTrials.gov