Treatment for adult patients with specific types of lymphoma and leukemia

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

This study is testing a new treatment plan using a combination of medications before a stem cell transplant to see if it helps adults with certain types of lymphoma and leukemia stay in remission.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhuhai, Guangdong)
• Trial ID: NCT06060782 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a conditioning regimen consisting of thiotepa, cyclophosphamide, cladribine, and cytarabine in adult patients diagnosed with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia prior to undergoing autologous hematopoietic stem cell transplantation (auto-HSCT). It aims to include 28 patients who will receive this regimen as pre-transplant treatment, followed by a year of maintenance therapy to monitor outcomes. The study focuses on patients who have achieved specific remission criteria after initial chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with confirmed diagnoses of Burkitt lymphoma, lymphoblastic lymphoma, or acute lymphoblastic leukemia who meet specific remission criteria.

Not a fit: Patients outside the age range of 18 to 65 or those who do not meet the remission criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with aggressive lymphomas and leukemias by enhancing the effectiveness of stem cell transplantation.

How similar studies have performed: While this approach is based on established treatments, the specific combination and its application in this patient population may offer novel insights, though similar studies have shown promise in related contexts.

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

Where this trial is running

Zhuhai, Guangdong

• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (RECRUITING)

Conditions: Burkitt Lymphoma, Lymphoblastic Lymphoma, Adult, Acute Lymphoblastic Leukemia, Adult, Thiotepa, Cyclophosphamide, Cladribine, Cytarabine, conditioning regimen