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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAP regimen | Experimental | The combination regimen of etoposide, cytarabine and PEG-rhG-CSF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Day 1~Day 2: 75mg/m^2 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients achieving the collection of #5×10^6 CD34+ cells/kg. | 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. | 4 weeks |
| TRAEs |
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Inclusion Criteria:
Exclusion Criteria:
Patients with severe cardiac, hepatic or renal insufficiency, such as:
History of hematopoietic stem cell mobilization.
Patients with active infection.
Female subjects who are pregnant or lactating.
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.
Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Lu | Contact | +86-13486090834 | 814871416@qq.com | |
| Peipei Ye | Contact | +86-13685832706 | 39612903@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Lu | The Affiliated People's Hospital of Ningbo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongyang People's Hospital | Recruiting | Dongyang | Zhejiang | China |
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| Cytarabine | Drug | Day 1~Day 2: 200mg/m^2, q12h |
|
|
| PEG-rhG-CSF | Drug | Day 6: 6mg |
|
Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
| 4 weeks |
| Time from PEG-rhG-CSF mobilization to HSC collection. | To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC. | 4 weeks |
| The average collection times of EAP scheme | 4 weeks |
| Hematopoietic reconstitution and therapeutic adverse events after transplantation | 4 weeks |
| Tongde Hospital of Zhejiang Province | Recruiting | Hangzhou | Zhejiang | 310012 | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310024 | China |
|
| Huzhou central hospital | Recruiting | Huzhou | Zhejiang | China |
|
| Jinhua Municipal Central Hospital | Recruiting | Jinhua | Zhejiang | 321000 | China |
|
| Jinhua People's Hospital | Recruiting | Jinhua | Zhejiang | 321099 | China |
|
| Lishui Municipal Central Hospital | Recruiting | Lishui | Zhejiang | 323000 | China |
|
| The Affiliated People's Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315040 | China |
|
| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | China |
|
| Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University | Recruiting | Shaoxing | Zhejiang | 312000 | China |
|
| Shaoxing Second Hospital | Recruiting | Shaoxing | Zhejiang | 312099 | China |
|
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | 317099 | China |
|
| Taizhou Central Hospital | Recruiting | Taizhou | Zhejiang | China |
|
| The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU | Recruiting | Wenzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D003561 | Cytarabine |
| C423652 | pegylated granulocyte colony-stimulating factor |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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