Comparing two chemotherapy regimens for stem cell mobilization in lymphoma patients
A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy vs. Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma
This study is testing a new combination of chemotherapy drugs to see if it helps lymphoma patients collect enough stem cells for treatment better than the standard approach.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated People's Hospital of Ningbo University Government |
| Drugs / interventions | chemotherapy |
| Locations | 17 sites (Dongyang, Zhejiang and 16 other locations) |
| Trial ID | NCT06520163 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination therapy involving etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma. A total of 99 patients will be randomly assigned to receive either this experimental regimen or a disease-specific chemotherapy regimen. The primary goal is to determine the proportion of patients achieving the ideal collection of CD34+ cells after a single collection. The study will also monitor adverse reactions and the overall effectiveness of both treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with non-Hodgkin's lymphoma who are indicated for autologous stem cell transplantation.
Not a fit: Patients with significant cardiac issues, liver dysfunction, or those who have previously undergone stem cell mobilization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the efficiency of stem cell mobilization in lymphoma patients, potentially leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promise with similar chemotherapy regimens for stem cell mobilization, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with non-Hodgkin's lymphoma before enrollment. * Indication for autologous stem cell transplantation (ASCT). * Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1. * Achieved complete remission after multiple courses of chemotherapy. * Life expectancy ≥ 3 months. * Subjects must be able to understand the protocol and sign the informed consent. Exclusion Criteria: * Cardiac function class II or higher or cardiac ejection fraction \< 40%. * Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN). * Serum creatinine clearance rate ≤ 50%. * Patients with active infection. * History of prior hematopoietic stem cell mobilization.
Where this trial is running
Dongyang, Zhejiang and 16 other locations
- Dongyang People's Hospital — Dongyang, Zhejiang, China (Recruiting)
- The Affiliated Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- Tongde Hospital of Zhejiang Province — Hangzhou, Zhejiang, China (Recruiting)
- Huzhou central hospital — Huzhou, Zhejiang, China (Recruiting)
- The First Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)
- Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China (Recruiting)
- Jinhua People's Hospital — Jinhua, Zhejiang, China (Recruiting)
- Lishui Central Hospital — Lishui, Zhejiang, China (Recruiting)
- Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)
- The Affiliated People's Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
- Shaoxing People's Hospital — Shaoxing, Zhejiang, China (Recruiting)
- Shaoxing Second Hospital — Shaoxing, Zhejiang, China (Recruiting)
- Taizhou Central Hospital — Taizhou, Zhejiang, China (Recruiting)
- Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)
- The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China (Recruiting)
Study contacts
- Principal investigator: Peipei Ye — The Affiliated People's Hospital of Ningbo University
- Study coordinator: Peipei Ye
- Email: 39612903@qq.com
- Phone: 86-13685832706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.