Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT06060782

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Led by Fifth Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-03-06

28

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent form themselves
  • Confirmed diagnosis of acute lymphoblastic leukemia (ALL) by bone marrow cell morphology, immunology, and genetics
  • PH+ALL patients who achieve early molecular remission (s3CMR) within 3 months and maintain remission
  • PH-B-ALL patients who reach MRD- after 3 chemotherapy courses and continue MRD-
  • Adult patients with Burkitt lymphoma and lymphoblastic lymphoma confirmed by histopathology and molecular genetics
  • Adult Burkitt lymphoma and lymphoblastic lymphoma patients with non-involved bone marrow achieving partial remission or better after induction
  • If bone marrow was involved at diagnosis, patients must achieve MRD- after 3 chemotherapy courses and maintain MRD-
  • Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT)
  • Age between 18 and 65 years, male or female
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2
Not Eligible

You will not qualify if you...

  • History of cancer and treatment for this tumor within the past 3 years, except superficial bladder cancer, skin basal or squamous cell carcinoma, cervical intraepithelial carcinoma, or prostate epithelium internal carcinogenesis
  • Known seropositivity for HIV, active hepatitis B or C, or syphilis
  • Mental illness or conditions preventing cooperation with treatment and monitoring
  • Pregnancy or inability to use appropriate contraception during treatment
  • Received hematopoietic stem cell transplantation within the past 1 year
  • Active heart disease including uncontrolled angina, recent myocardial infarction (less than 6 months), severe arrhythmia, uncontrolled congestive heart failure, or low ejection fraction
  • Planned major surgery within 4 weeks before enrollment or during the study, or unhealed surgical wounds
  • Received live vaccines within 4 weeks before enrollment
  • Suspected active or latent tuberculosis
  • Participation in other clinical trials within 1 month before enrollment
  • Any condition deemed unsuitable for enrollment by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China, 519000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine | DecenTrialz