Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Burkitt Lymphoma Clinical Trial

— TCCA  

Official title:

Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060782
• Other study ID #: ZDWY.XYZLK.002
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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:

1. Have a history of uncontrolled or symptomatic angina;

2. Myocardial infarction less than 6 months from study enrollment;

3. Have a history of arrhythmia that requires drug treatment or has severe clinical symptoms;

4. Uncontrolled or symptomatic congestive heart failure (>NYHA class 2);

5. The ejection fraction is lower than the lower limit of the normal range. 7.

Patients who meet the following criteria:

1. 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;

2. Those who have received (attenuated) live vaccines within 4 weeks before enrollment;

3. Patients with suspected active or latent tuberculosis;

4. Participate in other clinical trials one month before enrollment 8. Those who the researcher believes are not suitable for enrollment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Adult
• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen
All 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

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year recurrence-free survival rate		3 years after transplantation
Secondary	3-year overall survival rate		3 years after transplantation
Secondary	3-year recurrence rate		3 years after transplantation
Secondary	Transplant-related mortality		From the beginning of conditioning to 3 years after transplantation
Secondary	The patient's tolerance and mucositis grade		From the beginning of conditioning chemotherapy to hematopoietic reconstitution
Secondary	The incidence of cataracts and second tumors		From the beginning of conditioning to 3 years after transplantation