Clinical trial NCT05510089: Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematological Malignancy
Keywords: Etoposide
Cytarabine
PEG-rhG-CSF
Hematological Malignancies
Hematopoietic Stem Cell Mobilization
Lead sponsor: The Affiliated People's Hospital of Ningbo University
Sponsor class: OTHER_GOV
First posted: 2022-08-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
timeFrame: 4 weeks
Secondary outcomes:
measure: % of patients achieving the collection of >5×10^6 CD34+ cells/kg.
timeFrame: 4 weeks
measure: TRAEs
timeFrame: 4 weeks
measure: Time from PEG-rhG-CSF mobilization to HSC collection.
timeFrame: 4 weeks
measure: The average collection times of EAP regimen
timeFrame: 4 weeks
measure: Hematopoietic reconstitution and therapeutic adverse events after transplantation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou central hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua People's Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University.
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Second Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: The Affiliated People's Hospital of Ningbo University
name: Ying Lu
role: PRINCIPAL_INVESTIGATOR
References: