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

NCT05510089 — Not applicable, Unknown, 62 participants, The Affiliated People's Hospital of Ningbo University

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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

Registry	NCT05510089
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	62 (Estimated)
Sponsor	The Affiliated People's Hospital of Ningbo University (Other gov)
Conditions	Hematological Malignancy
Interventions	Etoposide, Cytarabine, PEG-rhG-CSF (Drug)
Dates	start 2022-09-01, primary completion 2024-05-31 (estimated), completion 2024-12-31 (estimated), first posted 2022-08-22, last updated 2023-10-10
Locations	12 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
EAP regimen	Experimental	Drug: Etoposide; Drug: Cytarabine; Drug: PEG-rhG-CSF	The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

Etoposide (Drug), also known as VP-16: D1\~D2: 75mg/m\^2
Cytarabine (Drug), also known as Ara-C: D1\~D2: 300mg/m\^2, q12h
PEG-rhG-CSF (Drug): D6: 6mg

+Outcome measures

Primary outcomes

% 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 outcomes

% 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]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (12)

Facility	City	Country	Status
Dongyang People's Hospital	Dongyang, Zhejiang	China	Recruiting
Tongde Hospital of Zhejiang Province	Hangzhou, Zhejiang	China	Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou, Zhejiang	China	Recruiting
Huzhou central hospital	Huzhou, Zhejiang	China	Recruiting
Jinhua Municipal Central Hospital	Jinhua, Zhejiang	China	Recruiting
Jinhua People's Hospital	Jinhua, Zhejiang	China	Recruiting
Lishui Municipal Central Hospital	Lishui, Zhejiang	China	Recruiting
The Affiliated People's Hospital of Ningbo University.	Ningbo, Zhejiang	China	Recruiting
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University	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

+Investigators

Ying Lu, Principal investigator, The Affiliated People's Hospital of Ningbo University

My Notes

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