Skip to content

A multicenter, prospective, cohort study on the efficacy and safety of auto HSCT in all patients undergoing MCAC or TCAC pretreatment

A multicenter, prospective, cohort study on the efficacy and safety of auto HSCT in all patients undergoing MCAC or TCAC pretreatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063863
Enrollment
Unknown
Registered
2022-09-19
Start date
2022-09-19
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALL

Interventions

1:MCAC
2:TCAC

Sponsors

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1) All patients diagnosed by bone marrow cell morphology, immunology and genetics; 2) Ph + all patients who reach s3cmr (definition: achieve molecular biological remission in the early stage of initial treatment (within 3 months) and continue to achieve remission); 3) Patients with ph-b-all who reached MRD - and continued MRD - after 3 courses of chemotherapy; 4) Patients receiving autologous hematopoietic stem cell transplantation (auto HSCT); 5) Age = 18 years old and = 65 years old, male and female; 6) The physical status assessment (ECOG-PS) of the eastern oncology collaboration group was 0-2 points; 7) The informed consent form must be signed before the study procedure, and the informed consent form must be signed by the patient himself or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member shall sign the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Subjects who meet any of the following criteria shall not be included in this study: 1) Have a history of central nervous system leukemia and extramedullary infiltration; 2) ETP-ALL,Ph-like-ALL,T-ALL; 3) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except superficial bladder cancer, basal cell or squamous cell carcinoma of skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN); 4) Serological reaction of HIV, active hepatitis B and active hepatitis C virus is known to be positive or syphilis is positive; 5) Suffering from mental illness or other conditions and unable to meet the requirements of research treatment and monitoring; 6) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 7) Have received hematopoietic stem cell transplantation in the past 1 year; 8) Active heart disease is defined as one or more of the following: a) Have a history of uncontrolled or symptomatic angina; b) Myocardial infarction less than 6 months before the study; c) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; d) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); e) The ejection fraction was lower than the lower limit of the normal range. 9) Patients who meet the following criteria: a) 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; b) Those who had received (attenuated) active vaccine within 4 weeks before enrollment; c) Patients with suspected active or latent tuberculosis; d) Participate in other clinical trials one month before enrollment 10) The investigator considered that it was not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
RFS;

Countries

China

Contacts

Public ContactErlie Jiang
jiangerlie@ihcams.ac.cn23909018

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026