Clinical trial NCT05536154: Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells 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) as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma
Multiple Myeloma
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: 2022-09-10
Enrollment: 68
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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. 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: In patients older than 65 years, or with creatinine \>2.5 mg/dL but with an endogenous creatinine clearance \>50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third.

Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection.

Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and \<20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were \<5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
3. Life expectancy ≥ 3 months.
4. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Exclusion Criteria:

1. Patients with severe cardiac, hepatic or renal insufficiency, such as:

   * Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN);
   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2× ULN;
   * Serum creatinine clearance rate≤50%;
   * Cardiac function class II or higher or severe arrhythmia.
2. History of hematopoietic stem cell mobilization.
3. Patients with active infection.
4. Female subjects who are pregnant or lactating.
5. Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, such as unstable heart disease, stroke, rheumatoid arthritis, lupus.
6. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
7. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.

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 scheme
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: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
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 Hospital of Zhejiang Province
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
state: Zhejiang
Study officials:
affiliation: The Affiliated People's Hospital of Ningbo University
name: Ying Lu
role: PRINCIPAL_INVESTIGATOR
References: