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Prospective, single-arm, multicenter exploratory clinical study of etoposide, cytarabine combined with pegylated recombinant human granulocyte-stimulating factor (ECP) regimen to mobilize hematopoietic stem cell in hematological malignancy patients with poor cell mobilization

Prospective, single-arm, multicenter exploratory clinical study of etoposide, cytarabine combined with pegylated recombinant human granulocyte-stimulating factor (ECP) regimen to mobilize hematopoietic stem cell in hematological malignancy patients with poor cell mobilization

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060869
Enrollment
Unknown
Registered
2022-06-13
Start date
2022-06-01
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.Based on the Gruppo italiano Trapianto di Midollo Osseo working group, hematological malignancy patients that are determined as Proven poor mobilizersor Predicted poor mobilizerswill be included. 2.There are indicators proving the patient can undergo Auto-HSCT. 3.ECOG rating of 0~2. 4.Age between 18 and 75. 5.More than 3 months of expected survival time. 6.Have signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Having severe cardiac, hepatic or renal insufficiency: II or above severe arrhythmia; bilirubin, alanine aminotransferase, and aspartate aminotransferase that are 2 times higher than the upper limit of normal threshold in serum; an endogenous creatinine clearance of <50% in serum; 2.Active infection; 3.Allergy to VP-16, Ara-C and PEG-rhG-CSF; 4.Pregnant or lactating woman; 5.Received live or live attenuated vaccines within four weeks before enrollment; 6.deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with target collection values for the EAP mobilization regimen;

Secondary

MeasureTime frame
Proportion of patients with ideal collection values for the EAP mobilization regimen;average number of collection;time of PEG-rhG-CSF mobilization until collection;toxic side effects of EAP regimen;independent variables that cause EAP mobilization failure;

Countries

China

Contacts

Public ContactPeipei Ye

The Affiliated People's Hospital of Ningbo University

39612903@qq.com+86 13685832706

Outcome results

None listed

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