Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

NCT ID: NCT06060782

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2026-12-31

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 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

Burkitt Lymphoma; Lymphoblastic Lymphoma, Adult; Acute Lymphoblastic Leukemia, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

subject group

Group Type: EXPERIMENTAL

Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

TCCA conditioning regimen group

Eligibility Criteria

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:

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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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

juan Lin Zeng, PhD

Role: primary

zenglinj@mail.sysu.edu.cn

13825613357

Juan Zhuang, Master's degree

Role: backup

zhuangj5@mail.sysu.edu.cn

13926926178

Other Identifiers

ZDWY.XYZLK.002

Identifier Type: -

Identifier Source: org_study_id