Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

NCT06060782 | Recruiting Phase 1 DMC

• 1 other identifier: ZDWY.XYZLK.002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

Thiotepa; Cyclophosphamide; Cladribine; Cytarabine; conditioning regimen

Outcome Measures

Primary Outcomes (1)

• 3-year recurrence-free survival rate

  3 years after transplantation

Secondary Outcomes (5)

• 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

Study Arms (1)

subject group

EXPERIMENTAL

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

Interventions

Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen 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

Also known as: TCCA conditioning regimen group

subject group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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); 7. Age ≥18 years and ≤65 years old, male or female; 8. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2;

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Thiotepa; Cyclophosphamide; Cladribine

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)