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Search / Trial NCT07059156

Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL

Launched by SHANXI BETHUNE HOSPITAL · Jul 1, 2025

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment plan for adults aged 18 to 60 who have a type of blood cancer called Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL). The goal is to see if combining different chemotherapy medicines with a special stem cell transplant can help patients stay cancer-free longer and improve their chances of survival. This treatment plan starts with a strong round of chemotherapy to kill cancer cells, followed by additional chemotherapy to keep the cancer under control. If eligible, patients will then receive a stem cell transplant from a donor to help rebuild healthy blood cells. The entire process is designed to be completed within about four months after diagnosis.

If you join this study, you will be closely monitored for up to two years to check how well the treatment is working and to watch for any side effects. To be eligible, you need to be between 18 and 60 years old and have a confirmed diagnosis of this specific leukemia, with good overall health that allows you to undergo intensive treatment. People with certain health problems, like severe heart issues or brain bleeding, or those who are pregnant, will not be able to participate. This study is currently recruiting patients, and it aims to offer a more effective treatment that lowers the chance of the cancer coming back and improves long-term health outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age: 18 to 60 years;
  • 2. Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts/immature lymphocytes in bone marrow (Note: Patients with \<20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis);
  • 3. ECOG Performance Status: 0-2
  • Exclusion Criteria:
  • 1. Intracranial hemorrhage
  • 2. Pregnancy
  • 3. Psychiatric disorders or other conditions compromising protocol compliance
  • 4. Severe cardiac arrhythmia with ECG abnormalities (QTc \>500 ms)

About Shanxi Bethune Hospital

Shanxi Bethune Hospital is a leading healthcare institution located in Shanxi province, China, dedicated to advancing medical research and enhancing patient care through innovative clinical trials. As a prominent clinical trial sponsor, the hospital is committed to adhering to the highest ethical standards and regulatory guidelines to ensure the safety and efficacy of new treatments. With a multidisciplinary team of experienced researchers and healthcare professionals, Shanxi Bethune Hospital fosters collaboration and utilizes state-of-the-art facilities to facilitate groundbreaking studies that aim to improve health outcomes and contribute to the global medical community.

Locations

Taiyuan, Shanxi, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported