Clinical trial · Interventional
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic Stem Cell Mobilization | — | UNRESOLVED | — |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP | Combination Product | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| DA-EPOCH | Combination Product | — | UNRESOLVED |
| DICE | Combination Product | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| GDP | Combination Product | — | UNRESOLVED |
| GDPE | Combination Product | — | UNRESOLVED |
| Hyper-CVAD | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EAP regimen group
- description
- 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
- interventionNames
- Drug: Etoposide
- Drug: Cytarabine
- Drug: PEG-rhG-CSF
- Drug: G-CSF
- type
- ACTIVE_COMPARATOR
- label
- Disease-specific chemotherapy mobilization regimens group
- description
- 33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
- interventionNames
- Combination Product: CHOP
- Combination Product: Hyper-CVAD
- Combination Product: ID-MTX + Ara-C
- Combination Product: DA-EPOCH
- Combination Product: GDP
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available