NCT06520163 Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
| NCT ID | NCT06520163 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Affiliated People's Hospital of Ningbo University |
| Condition | Non-Hodgkin's Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 99 participants in total. It began in 2024-08-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10\^6/kg).
Eligibility 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.
Contact & Investigator
Peipei Ye
PRINCIPAL INVESTIGATOR
The Affiliated People's Hospital of Ningbo University
Frequently Asked Questions
Who can join the NCT06520163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Hodgkin's Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06520163 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 99 participants.
Is NCT06520163 currently recruiting?
Yes, NCT06520163 is actively recruiting participants. Contact the research team at 39612903@qq.com for enrollment information.
Where is the NCT06520163 trial being conducted?
This trial is being conducted at Dongyang, China, Hangzhou, China, Hangzhou, China, Hangzhou, China and 11 additional locations.
Who is sponsoring the NCT06520163 clinical trial?
NCT06520163 is sponsored by The Affiliated People's Hospital of Ningbo University. The principal investigator is Peipei Ye at The Affiliated People's Hospital of Ningbo University. The trial plans to enroll 99 participants.