Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | D1~D2: 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with severe cardiac, hepatic or renal insufficiency, such as:
Patients with active infection.
History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
Women who are pregnant or breastfeeding.
Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
For any other reasons, the patients are believed not suitable for participation in this study by investigators
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cytarabine |
| Drug |
D1~D2: 300mg/m^2, q12h |
|
|
| PEG-rhG-CSF | Drug | D6: 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 regimen | 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 | 315101 | China |
|
| Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University | Recruiting | Shaoxing | Zhejiang | 312000 | China |
|
| Shaoxing Second Hospital | Recruiting | Shaoxing | Zhejiang | 312099 | China |
|
| Taizhou Central Hospital | Recruiting | Taizhou | Zhejiang | China |
|
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided