LymphomaNCT05536154
Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
A study testing Etoposide, Cytarabine and PEG-rhG-CSF in people with Lymphoma and Multiple Myeloma, run by The Affiliated People's Hospital of Ningbo University at 14 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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma
- What is being tested?
- Etoposide, Cytarabine and PEG-rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 14 sitesChina
- Study dates
- 1 Nov 2022to Oct 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
- Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
- Life expectancy ≥ 3 months.
- Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
Who cannot join
- Patients with severe cardiac, hepatic or renal insufficiency, such as:
- Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;
- Serum creatinine clearance rate≤50%;
- Cardiac function class II or higher or severe arrhythmia.
- History of hematopoietic stem cell mobilization.
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- Patients with active infection.
- Female subjects who are pregnant or lactating.
- Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, such as unstable heart disease, stroke, rheumatoid arthritis, lupus.
- Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
- History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 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 Yu, +86-13750853563, 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 Huang, +86-13566782316, huanglixiaoyu@126.com
- Recruiting
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323000
Linjie Li, +86-13567615761, Lilinjie0394@163.com
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040
Ying Lu, +8613486090834, 814871416@qq.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Jing Le, 13566511755, nblejing@aliyun.com
- Recruiting
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Shaoxing, Zhejiang, 312000
Weiying Feng, +86-13588570250, fengweiying1997@126.com
- Recruiting
Shaoxing Second Hospital
Shaoxing, Zhejiang, 312099
Weiguo Zhu, +86-18767509030, yin990216@sina.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099
Jian Shen, +86-13758628257, hyperlool@126.com
- Recruiting
Taizhou Central Hospital
Taizhou, Zhejiang
Sai Chen, 13575809591, chens7111@tzzxyy.com
- Recruiting
The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang
Ying Lin, 13705883857, wzly1974@hotmail.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) as First Line Mobilization Regimen of Hematopoietic Stem Cells in 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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. 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.
Read the detailed description
In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third.
Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection.
Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.
- Conditions
- Lymphoma, Multiple Myeloma
- Being tested
- Etoposide, Cytarabine, PEG-rhG-CSF
- Keywords
- Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
- Medical subject headings
- Lymphoma, Multiple Myeloma, 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
Day 1~Day 2: 75mg/m^2
CytarabineDrug
Also called Ara-C
Day 1~Day 2: 200mg/m^2, q12h
PEG-rhG-CSFDrug
Day 6: 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 scheme
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 posted10 Sep 2022
- Study start1 Nov 2022
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 68 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
- NCT05536154
- Sponsor's protocol ID
- 2022-YAN-030
- Status last verified
- Mar 2024
- First submitted
- 7 Sep 2022
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. 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) as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05536154
- Acronym / sponsor ID
- 2022-YAN-030
- Conditions
- Lymphoma, Multiple Myeloma
- Keywords
- Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Affiliated People's Hospital of Ningbo UniversityOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Sep 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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. 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.
Detailed description
In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third.
Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection.
Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.
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 (4 listed)
- Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
- Life expectancy ≥ 3 months.
- Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
Key exclusion criteria (11 listed)
- Patients with severe cardiac, hepatic or renal insufficiency, such as:
- History of hematopoietic stem cell mobilization.
- Patients with active infection.
- Female subjects who are pregnant or lactating.
- Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, such as unstable heart disease, stroke, rheumatoid arthritis, lupus.
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-16Day 1~Day 2: 75mg/m^2 | Drug | EAP regimen |
| CytarabineAlso: Ara-CDay 1~Day 2: 200mg/m^2, q12h | Drug | EAP regimen |
| PEG-rhG-CSFDay 6: 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 scheme
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 19 Mar 2024.
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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
14 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 Lymphoma and Multiple Myeloma, run by The Affiliated People's Hospital of Ningbo University at 14 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 4 inclusion and 11 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 19 Mar 2024.