RecruitingPhase 1NCT06060782

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


Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Enrollment

28 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a pre-transplant chemotherapy preparation regimen (a combination of thiotepa, cyclophosphamide, clarithromycin, and cytarabine) for patients with acute lymphoblastic leukemia (ALL) who have achieved deep remission. **You may be eligible if...** - You have been diagnosed with ALL (a blood cancer) confirmed by bone marrow testing - If you have the Philadelphia chromosome (Ph+ALL): you achieved deep molecular remission early in treatment - If you have Ph-negative B-ALL: your leukemia is undetectable in the bone marrow after chemotherapy - You meet other specific remission criteria based on your ALL subtype **You may NOT be eligible if...** - You have not achieved remission - You have significant organ problems that would make intense chemotherapy unsafe - You have not signed informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThiotepa, 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)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

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NCT06060782


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