Hemophagocytic LymphohistiocytosisPhase 3NCT04077905
Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.
A Phase 3 study testing Pegylated liposomal doxorubicin, Etoposide and Methylprednisolone in people with Hemophagocytic Lymphohistiocytosis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis
- What is being tested?
- Pegylated liposomal doxorubicin, Etoposide and Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2019to 31 Jul 2021
- Phase
- Phase 3
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
- 2.Patients were older than 2 years of age.
- 3.Estimated survival time ≥ 1 week.
- 4.Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.
- 5.sign informed consent.
Who cannot join
- 1.Heart function above grade II (NYHA).
- 2.Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
- 3.Pregnancy or lactating Women.
- 4.Allergic to pegylated liposomal doxorubicin or etoposide.
- 5.Active bleeding of the internal organs.
- 6.HIV antibody positivity.
Show all 9Show fewer
- 7.Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).
- 8.Participate in other clinical research at the same time.
- 9.The researchers considered that patients are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing
Zhao Wang, PHD, 86-63139862, catenny@hotmail.com
About this study
Official title: A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis
This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis.
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Being tested
- Pegylated liposomal doxorubicin, Etoposide, Methylprednisolone
- Keywords
- pegylated liposomal doxorubicin
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
35mg/m² ivgtt on day 1
EtoposideDrug
100mg/m² ivgtt on day 1
2 mg/kg ivgtt or PO days 1 to 3, 0.75 mg/kg ivgtt or PO days 4 to 7, 0.25 mg/kg ivgtt or PO days 8 to 10, 0. 1 mg/kg ivgtt or PO days 11 to 14,
| Study group | Role | What they receive |
|---|---|---|
| DEP regimen | Experimental | pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles Receives: Drug: Pegylated liposomal doxorubicin; Drug: Etoposide; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
complete response (CR) and partial response (PR) rates
Measured: Time Frame: 1 years
Secondary outcomes (4)
Response rate of lymphoma
complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
Measured: Time Frame: 1 years
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause Overall Survival
Measured: Time Frame: 1 years
Overall Survival
from the date of inclusion to date of death, irrespective of cause Adverse Events
Measured: Time Frame: 1 years
Adverse Events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: Time Frame: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start31 Aug 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophagocytic LymphohistiocytosisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077905
- Sponsor's protocol ID
- CSPC-DMS-HLH-01
- Status last verified
- Sep 2019
- First submitted
- 31 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pi Y, Wang J, Zhou H, Ye X, Sun X, Liu L, Pan X, Wang Z. Modified DEP regimen as induction therapy for lymphoma-associated hemophagocytic lymphohistiocytosis: a prospective, multicenter study. J Cancer Res Clin Oncol. 2023 Jul;149(7):3033-3041. doi: 10.1007/s00432-022-04157-0. Epub 2022 Jul 19.
PubMed 35852619
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis
- ClinicalTrials.gov ID
- NCT04077905
- Acronym / sponsor ID
- CSPC-DMS-HLH-01
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Keywords
- pegylated liposomal doxorubicin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 4 Sep 2019 (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 study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEP regimen | Experimental | Drug: Pegylated liposomal doxorubicin, Drug: Etoposide, Drug: Methylprednisolonepegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
- 2.Patients were older than 2 years of age.
- 3.Estimated survival time ≥ 1 week.
- 4.Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.
- 5.sign informed consent.
Key exclusion criteria (9 listed)
- 1.Heart function above grade II (NYHA).
- 2.Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
- 3.Pregnancy or lactating Women.
- 4.Allergic to pegylated liposomal doxorubicin or etoposide.
- 5.Active bleeding of the internal organs.
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 |
|---|---|---|
| Pegylated liposomal doxorubicin35mg/m² ivgtt on day 1 | Drug | DEP regimen |
| Etoposide100mg/m² ivgtt on day 1 | Drug | DEP regimen |
| Methylprednisolone2 mg/kg ivgtt or PO days 1 to 3, 0.75 mg/kg ivgtt or PO days 4 to 7, 0.25 mg/kg ivgtt or PO days 8 to 10, 0. 1 mg/kg ivgtt or PO days 11 to 14, | Drug | DEP regimen |
Primary outcome
Response rate
Time frame: Time Frame: 1 years
complete response (CR) and partial response (PR) rates
4 secondary outcomes
Response rate of lymphoma
Time frame: Time Frame: 1 years
Progression Free Survival
Time frame: Time Frame: 1 years
Overall Survival
Time frame: Time Frame: 1 years
Adverse Events
Time frame: Time Frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 35852619Pi Y, Wang J, Zhou H, Ye X, Sun X, Liu L, Pan X, Wang Z. Modified DEP regimen as induction therapy for lymphoma-associated hemophagocytic lymphohistiocytosis: a prospective, multicenter study. J Cancer Res Clin Oncol. 2023 Jul;149(7):3033-3041. doi: 10.1007/s00432-022-04157-0. Epub 2022 Jul 19.
- Individual participant dataSharing planned: No
Related trials for Hemophagocytic Lymphohistiocytosis
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Not yet recruitingObservational study
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis After Allogeneic Stem Cell Transplantation
Hemophagocytic Lymphohistiocytosis (HLH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated liposomal doxorubicin, Etoposide and Methylprednisolone in people with Hemophagocytic Lymphohistiocytosis, run by Beijing Friendship Hospital at 1 site 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 5 inclusion and 9 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhao Wang, PHD (86-1063139862, catenny@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Time Frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077905, which also lists 1 linked publication.
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 6 Sep 2019.