Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies

Not Applicable

Recruiting

• Conditions: Hematological Malignancy
• Interventions: Drug: Etoposide; Drug: Cytarabine; Drug: PEG-rhG-CSF

• Registration Number: NCT05510089
• Lead Sponsor: The Affiliated People's Hospital of Ningbo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Study Start: 2022-09-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EAP regimen	PEG-rhG-CSF	The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
EAP regimen	Etoposide	The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
EAP regimen	Cytarabine	The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

Primary Outcome Measures

Name	Time	Method
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.	4 weeks	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 Outcome Measures

Name	Time	Method
% of patients achieving the collection of >5×10^6 CD34+ cells/kg.	4 weeks	The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of \>5×10\^6/kg.
TRAEs	4 weeks	Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
Time from PEG-rhG-CSF mobilization to HSC collection.	4 weeks	To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.
The average collection times of EAP regimen	4 weeks
Hematopoietic reconstitution and therapeutic adverse events after transplantation	4 weeks

Trial Locations

Locations (12)

Huzhou central hospital; 🇨🇳 Huzhou, Zhejiang, China

Dongyang People's Hospital; 🇨🇳 Dongyang, Zhejiang, China

The Affiliated People's Hospital of Ningbo University.; 🇨🇳 Ningbo, Zhejiang, China

Tongde Hospital of Zhejiang Province; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Lishui Municipal Central Hospital; 🇨🇳 Lishui, Zhejiang, China

Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University; 🇨🇳 Shaoxing, Zhejiang, China

Shaoxing Second Hospital; 🇨🇳 Shaoxing, Zhejiang, China

Taizhou Central Hospital; 🇨🇳 Taizhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province; 🇨🇳 Taizhou, Zhejiang, China

Jinhua People's Hospital; 🇨🇳 Jinhua, Zhejiang, China

Jinhua Municipal Central Hospital; 🇨🇳 Jinhua, Zhejiang, China