Hematological Malignancy
Conditions
Keywords
Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
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.
Interventions
DRUGEtoposide
D1\ D2: 75mg/m\^2
DRUGCytarabine
D1\ D2: 300mg/m\^2, q12h
DRUGPEG-rhG-CSF
D6: 6mg
Sponsors
The Affiliated People's Hospital of Ningbo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % 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
| Measure | Time frame | Description |
|---|---|---|
| % 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 | — |
Countries
China
Contacts
Primary ContactYing Lu
Backup ContactPeipei Ye
Outcome results
None listed