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Etoposide, cytarabine combined with pegylated recombinant human granulocyte-stimulating factor (EAP) regimen to mobilize hematopoietic stem cell in hematological malignancy patients: A prospective single-arm, multi-center exploratory clinical study.

Etoposide, cytarabine combined with pegylated recombinant human granulocyte-stimulating factor (EAP) regimen to mobilize hematopoietic stem cell in hematological malignancy patients: A prospective single-arm, multi-center exploratory clinical study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060870
Enrollment
Unknown
Registered
2022-06-13
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematological malignancies

Interventions

experimental group :EAP regimen

Sponsors

The Affiliated People's Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Lymphoma or multiple myeloma patients with indications for autologous hematopoietic stem cell transplantation; 2.ECOG score of 0~2; 3.Age between 18 and 75; 4.More than 3 months of expected survival time; 5.Ability to sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Having severe cardiac, hepatic or renal insufficiency: Serum direct bilirubin, alanine aminotransferase, and aspartate aminotransferase are 2 times higher than the upper limit of normal threshold; an endogenous creatinine clearance of <=50% in serum; cardiac function class II or above or severe arrhythmia; 2.Having history of hematopoietic stem cell mobilization (regardless of protocol); 3.Active infection; 4.Pregnant or lactating woman; 5.Any serious medical condition that would put the patient at an unacceptable risk in participating in this study, or that would require continued active treatment, such as unstable heart disease, stroke, rheumatoid arthritis, lupus, etc.; 6.Received live or live attenuated vaccines within four weeks before enrollment; 7.Patients who cannot receive follow-up treatment in the designated unit of this program, who cannot understand and comply with the research protocol or who cannot sign the informed consent form; 8.Allergy to VP-16, Ara-C and PEG-rhG-CSF.

Design outcomes

Primary

MeasureTime frame
when EAP regimen help patients to reach target proportion of collection values;

Secondary

MeasureTime frame
EAP mobilization regimen reaches ideal proportion of collection value;average number of collection;frequency of FN rate; proportion of patients with red cell infusion with ECP regimen;proportion of patients with red cell infusion with EAP regimen;proportion of patients with platelets infusion with EAP regimen.;

Countries

China

Contacts

Public ContactYing Lu
814871416@qq.com+86 13486090834

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026