Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

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

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine (NCT06060782) is a Phase 1 interventional studying Burkitt Lymphoma and Lymphoblastic Lymphoma, Adult, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Burkitt Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 28 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. Voluntarily sign the willing to sign a consent form 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; Who Should NOT Join This Trial: - 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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:  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

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06060782), the sponsor (Fifth Affiliated Hospital, Sun Yat-Sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06060782 clinical trial studying?

Who can participate in NCT06060782?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06060782?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06060782. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06060782. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.