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A prospective research: in the PTCY regimen, Bendamustine was used to replace Fludarabine for haploid hematopoietic stem cell transplantation.

A prospective research: in the PTCY regimen, Bendamustine was used to replace Fludarabine haploid hematopoietic stem cell transplantation.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045050
Enrollment
Unknown
Registered
2021-04-04
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Hematological Disease

Interventions

experimental group:Bendamustine+Busulfan
control group:Fludarabine+Busulfan

Sponsors

Department of Hematology, The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Primary hematological diseases include acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, lymphoma, myelodysplastic syndrome, and have allogeneic hematopoietic stem cell transplantation indications; 2.Aged 18-70 years, regardless of gender and race; 3.Take the test voluntarily and sign the informed consent form; 4.ECOG score <= 2 points.

Exclusion criteria

Exclusion criteria: 1.Subjects have active infections, such as hepatitis B, tuberculosis, etc.; 2.The subjects main organ function is impaired: with severe cardiac insufficiency, cardiac ejection fraction (EF) less than 60%, or severe arrhythmia, the investigator evaluates those who cannot tolerate the treatment; with severe pulmonary insufficiency (obstruction or restrictive ventilatory disorders), the investigator evaluates those who cannot tolerate the treatment; with severe liver function impairment, the liver function index (ALT, TBIL) is more than 3 times the upper limit of normal (ULN), the investigator evaluates the intolerable Treated patients; with severe renal insufficiency, renal function index (Cr) greater than the upper limit of normal (ULN) more than 2 times, or 24-hour urinary creatinine clearance rate (Ccr) less than 50ml/min, the investigator evaluates those who cannot tolerate treatment; 3.Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 4.There are clinical symptoms of brain dysfunction or serious mental illness, unable to understand or follow the research plan; 5.Combined with other malignant tumors in need of treatment; 6.Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation; 7.The investigator judges that the subject cannot comply with the research requirements.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
objective response rate;clinical benefit rate;overall survival;quality of life;vital signs;laboratory indicators;adverse events;serious adverse event;

Countries

China

Contacts

Public ContactLuo Yun

Department of Hematology, The Second Affiliated Hospital of Chongqing Medical University

300333@cqmu.edu.cn+86 13452393932

Outcome results

None listed

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