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Efficacy and safety of autologous hematopoietic stem cell transplantation with BGB regimen (Busulfan + Gemcitabine + Bendamustine) for patients with replased/refractory non-Hodgkin's lymphoma: a prospective, single arm, open lable study

Efficacy and safety of autologous hematopoietic stem cell transplantation with BGB regimen (Busulfan + Gemcitabine + Bendamustine) for patients with replased/refractory non-Hodgkin's lymphoma: a prospective, single arm, open lable study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054730
Enrollment
Unknown
Registered
2021-12-25
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

Non-Hodgkin’s lymphome

Interventions

BGB group:received BGB regimen

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years; 2. Gender: male or female; 3. Diagnosed as relapsed or refractory non-Hodgkin lymphoma; 4. Have indications for autologous hematopoietic stem cell transplantation; 5. The general condition is OK, and the ECOG score is less than or equal to 1 point; 6. Normal cardiac function: ejection fraction >= 50%; 7. Normal liver and kidney function: blood bilirubin<=35µmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine<=130µmol/L; 8. Subjects signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Has undergone autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation; 2. Serious bacterial and fungal infections were not controlled before transplantation; 3. Pregnant or breastfeeding women; 4. History of other malignant tumors other than hematological malignancies within 3 years; 5. Known infection with human immunodeficiency virus (HIV); 6. Other situations that do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
overall survival;recurrence-free survival;

Secondary

MeasureTime frame
Implantation rate;Incidence of mucositis;transplant-related death;

Countries

China

Contacts

Public ContactZhang Yicheng

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

yczhang@tjh.tjmu.edu.cn+86 18607140317

Outcome results

None listed

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