Hematological MalignancyNCT05510089
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
A study testing Etoposide, Cytarabine and PEG-rhG-CSF in people with Hematological Malignancy, run by The Affiliated People's Hospital of Ningbo University at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- Etoposide, Cytarabine and PEG-rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 12 sitesChina
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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".
- Patients with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
- Patients should be within age range of ≥18 and ≤75 years old.
- Life expectancy ≥ 3 months.
- Patients must be able to sign informed consent.
Who cannot join
- 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%.
- Patients with active infection.
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Dongyang People's Hospital
Dongyang, Zhejiang
Gongqiang Wu, 13757950788, wugongqiang59@126.com
- Recruiting
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310012
Huifang Jiang, +86-13957182087, jianghuifang501@163.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310024
Wenjuan O Yu, +8613750853563, drwjyu@163.com
- Recruiting
Huzhou central hospital
Huzhou, Zhejiang
Lihong Shou, 13587206019, SLH077@126.com
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Huixian Hu, +86-13588652288, huhuixian@zju.edu.cn
- Recruiting
Jinhua People's Hospital
Jinhua, Zhejiang, 321099
Li P Huang, +86-13566782316, huanglixiaoyu@126.com
- Recruiting
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323000
Linjie C Li, +86-13567615761, Lilinjie0394@163.com
- Recruiting
The Affiliated People's Hospital of Ningbo University.
Ningbo, Zhejiang, 315101
Peipei Ye, 86-0574-87016871, 39612903@qq.com
- Recruiting
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Shaoxing, Zhejiang, 312000
Weiying Z Feng, +86-13588570250, fengweiying1997@126.com
- Recruiting
Shaoxing Second Hospital
Shaoxing, Zhejiang, 312099
Weiguo S Zhu, +86-18767509030, yin990216@sina.com
- Recruiting
Taizhou Central Hospital
Taizhou, Zhejiang
Sai Chen, 13575809591, chens7111@tzzxyy.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Jian Z Shen, +86-13758628257, hyperlool@126.com
About this study
Official title: Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies
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.
- Conditions
- Hematological Malignancy
- Being tested
- Etoposide, Cytarabine, PEG-rhG-CSF
- Keywords
- Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called VP-16
D1~D2: 75mg/m^2
CytarabineDrug
Also called Ara-C
D1~D2: 300mg/m^2, q12h
PEG-rhG-CSFDrug
D6: 6mg
| Study group | Role | What they receive |
|---|---|---|
| EAP regimen | Experimental | The combination regimen of etoposide, cytarabine and PEG-rhG-CSF. Receives: Drug: Etoposide; Drug: Cytarabine; Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 4 weeks
Secondary outcomes (5)
% 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.
Measured: 4 weeks
TRAEs
Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
Measured: 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.
Measured: 4 weeks
The average collection times of EAP regimen
Measured: 4 weeks
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ying Lu, Principal investigator, The Affiliated People's Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510089
- Sponsor's protocol ID
- 2022-YAN-019
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05510089
- Acronym / sponsor ID
- 2022-YAN-019
- Conditions
- Hematological Malignancy
- Keywords
- Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The Affiliated People's Hospital of Ningbo UniversityOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EAP regimen | Experimental | Drug: Etoposide, Drug: Cytarabine, Drug: PEG-rhG-CSFThe combination regimen of etoposide, cytarabine and PEG-rhG-CSF. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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".
- Patients with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
- Patients should be within age range of ≥18 and ≤75 years old.
- Life expectancy ≥ 3 months.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoposideAlso: VP-16D1~D2: 75mg/m^2 | Drug | EAP regimen |
| CytarabineAlso: Ara-CD1~D2: 300mg/m^2, q12h | Drug | EAP regimen |
| PEG-rhG-CSFD6: 6mg | Drug | EAP regimen |
Primary outcome
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
Time frame: 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.
5 secondary outcomes
% of patients achieving the collection of >5×10^6 CD34+ cells/kg.
Time frame: 4 weeks
TRAEs
Time frame: 4 weeks
Time from PEG-rhG-CSF mobilization to HSC collection.
Time frame: 4 weeks
The average collection times of EAP regimen
Time frame: 4 weeks
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Lu principal investigator
The Affiliated People's Hospital of Ningbo University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etoposide, Cytarabine and PEG-rhG-CSF in people with Hematological Malignancy, run by The Affiliated People's Hospital of Ningbo University at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Lu (86-13486090834, 814871416@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.