Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-12-31

Brief Summary

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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) 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.

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Detailed Description

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Conditions

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Hematological Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EAP regimen

The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

Group Type EXPERIMENTAL

Etoposide

Intervention Type DRUG

D1\~D2: 75mg/m\^2

Cytarabine

Intervention Type DRUG

D1\~D2: 300mg/m\^2, q12h

PEG-rhG-CSF

Intervention Type DRUG

D6: 6mg

Interventions

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Etoposide

D1\~D2: 75mg/m\^2

Intervention Type DRUG

Cytarabine

D1\~D2: 300mg/m\^2, q12h

Intervention Type DRUG

PEG-rhG-CSF

D6: 6mg

Intervention Type DRUG

Other Intervention Names

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VP-16 Ara-C

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No