TCCA: Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06060782

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burkitt Lymphoma Lymphoblastic Lymphoma, Adult Acute Lymphoblastic Leukemia, Adult	Drug: Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: subject group	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 Other Names: TCCA conditioning regimen group

Arm

Intervention/Treatment

Experimental: subject group

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

Other Names:

TCCA conditioning regimen group

Outcome Measures

Primary Outcome Measures

3-year recurrence-free survival rate [3 years after transplantation]

Secondary Outcome Measures

3-year overall survival rate [3 years after transplantation]
3-year recurrence rate [3 years after transplantation]
Transplant-related mortality [From the beginning of conditioning to 3 years after transplantation]
The patient's tolerance and mucositis grade [From the beginning of conditioning chemotherapy to hematopoietic reconstitution]
The incidence of cataracts and second tumors [From the beginning of conditioning to 3 years after transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Voluntarily sign the informed consent form, which must be signed by the patient himself.

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-.
Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT);
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:

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:

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