Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Launched by FIFTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach using a combination of medications—Thiotepa, Cyclophosphamide, Clarithromycin, and Cytarabine—before a procedure called autologous hematopoietic stem cell transplantation (auto-HSCT) in adults with specific types of blood cancers, including Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia. The goal is to see how effective and safe this treatment is for patients who meet certain health criteria. The study aims to enroll 28 patients who will receive the TCCA treatment before their transplant and will be monitored for one year after the transplant to assess the treatment's success.

To participate in the trial, patients should be between 18 and 65 years old and must have been diagnosed with one of the cancers mentioned. They need to show that they have responded well to previous treatments and meet other health criteria. Participants can expect to undergo the TCCA treatment followed by the transplant, and then they will receive maintenance therapy for a year to help maintain their health. It’s important for potential participants to discuss this option with their doctors, as there are specific health conditions that could prevent them from joining the trial.

Gender

ALL

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