Clinical trial · Interventional
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies
- 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 is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) on hematopoietic stem cell mobilization in poor mobilization patients with hematological malignancies. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EAP regimen
- description
- The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
- interventionNames
- Drug: Etoposide
- Drug: Cytarabine
- Drug: PEG-rhG-CSF
Primary outcomes (1)
- measure
- % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
- timeFrame
- 4 weeks
- description
- The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of ≥2×10\^6/kg.
Secondary outcomes (5)
- measure
- % of patients achieving the collection of >5×10^6 CD34+ cells/kg.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. According to the diagnostic criteria of the Italian transplantation working group, patients with multiple myeloma or lymphoma diagnosed as "confirmed poor mobilization" or "predicted poor mobilization". 2. Patients with auto-HSCT indication. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2. 4. Patients should be within age range of ≥18 and ≤75 years old. 5. Life expectancy ≥ 3 months. 6. Patients must be able to sign informed consent. Exclusion Criteria: 1. Patients with severe cardiac, hepatic or renal insufficiency, such as: * Cardiac function class II or higher or severe arrhythmia; * Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN); * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2× ULN; * Serum creatinine clearance rate≤50%. 2. Patients with active infection. 3. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF. 4. Women who are pregnant or breastfeeding. 5. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment. 6. For any other reasons, the patients are believed not suitable for participation in this study by investigators
References
Publications (0)
Data not yet available