Hemophagocytic SyndromePhase 4RUE-DDGPNCT04999878
A Prospective Clinical Study of Ruxolitinib and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome.
A Phase 4 study testing Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum in people with Hemophagocytic Syndrome and T/NK-Cell Lymphoma, run by Zhengzhou University at 1 site in China.
Trial summary
To observe the efficacy and safety of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy of T cell lymphoma and NK/T cell lymphoma-associated hemophagocytic syndrome. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Hemophagocytic Syndrome, T/NK-Cell Lymphoma
- What is being tested?
- Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2021to 30 Jun 2024
- Phase
- Phase 4
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histopathologically proven T-cell lymphoma or NK/ T-cell lymphoma;
- Comply with HLH-2004 diagnostic criteria;Hemophagocytic syndrome can be diagnosed when either of the following two criteria is met:
- Molecular diagnosis is consistent with hemophagocytic syndrome. Pathological mutations were found in known pathogenic genes related to hemophagocytic syndrome, such as PRF1, UNC13D, STX11, STXBP2, RAB27A, LYST, SH2D1A, BIRC4, ITK, AP3B1, MAGT1, CD27, etc.
- Meet 5 of the following 8 indicators I. Fever: The body temperature was > 38.5℃, lasting > for 7 days. II. Splenomegaly . III. Hemocytopenia (involving two or three lines of peripheral blood) : hemoglobin < 90g/L, platelet < 100×10^9/L, neutrophils < 1.0×10^9/L and not caused by reduced hematopoietic function of bone marrow.
- Hypertriglyceridemia and/or hypofibrinogenemia: triglyceride > 3mmol/L or 3 standard deviations higher than the same age, fibrinogen < 1.5g/L or 3 standard deviations lower than the same age.
- Hemophagocytes are found in bone marrow, spleen, liver, or lymph nodes. VI.NK cell activity decreased or absent. VII. Elevated serum ferritin: ferritin ≥500μg/L. VIII. Elevated sCD25 (soluble interleukin-2 receptor).
Show all 10Show fewer
- Ages 14-75 years.
- Expected survival of more than 1 week.
- Patients with left ventricular ejection fraction > 50%, no major bleeding of active internal organs (digestive tract, lung, brain, etc.), and oxygenation index > 250.
- Patients have good compliance with the planned treatment and follow-up, can understand the research process of this study and sign the written informed consent.
Who cannot join
- Three or more drugs including ruxolitinb, etoposide, pemasparase, gemcitabine or cisplatin were used simultaneously in the previous 28 days.
- Pregnant or lactating women and patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this study. If the patient was male, they refused to use adequate contraception or sperm donation during the study period and for 3 months after the last study of lymphoma-related chemotherapy drugs.
- Allergic to any medication in the program.
- Grade III or IV heart disease based on the New York Heart Association (NYHA) score.
- Major active bleeding of internal organs (including gastrointestinal bleeding, alveolar bleeding, intracranial bleeding, etc.).
- Acute pancreatitis.
Show all 10Show fewer
- People infected with HIV (HIV antibody positive).
- HBV DNA copy number is >10^4/ml in patients with acute or chronic active hepatitis B, and HBV DNA copy number is >10^4/ml in patients with acute or chronic active hepatitis C (HCV antibody positive, HCV RNA negative acceptable).
- Participate in other clinical investigators.
- The investigators identified patients who were not eligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Doctor, 13838565629, mingzhi_zhang@126.com
About this study
Official title: A Prospective Clinical Study of Ruxolitinib Phosphate Tablets and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome.
To observe the efficacy and safety of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy of T cell lymphoma and NK/T cell lymphoma-associated hemophagocytic syndrome.
Read the detailed description
This is an open, one-arm, prospective clinical collaborative study. This study is aimed to observe the efficacy and safety of the new combined therapy of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy patients with primary central nervous system lymphoma. A total of 30 patients plan to participate in the study. The primary endpoint is objective remission rate (ORR) of hemophagocytic syndrome, and the secondary endpoints include progression-free survival (PFS) , objective remission rate (ORR) of lymphoma, overall survival (OS), and adverse events(ADR).
- Conditions
- Hemophagocytic Syndrome, T/NK-Cell Lymphoma
- Being tested
- Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum
- Keywords
- ruxolitinib, Lymphoma-associated Hemophagocytic Syndrome, Etoposide, Dexamethasone, Pegaspargase, Gemcitabine, cis-platinum
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinumDrug
All enrolled patients will receive a regimen containing Ruxilitinib, Etoposide, Dexamethasone, Gemcitabine, Pasparase and Platinum for 28 days. The specific medication is as follows:
Ruxilitinib 10 mg, bid, d1-28, P.O. Etoposide 100mg per week, two weeks, ivgtt Dexamethasone, 15mg/(m²·d)，d1-12，10 mg/ (m²·d) ，d13-14，5 mg/ (m²·d) ，d15-21，2.5mg/(m²·d)，d22-28，ivgtt or P.O.
Gemcitabine, 0.5 g/m², d8, ivgtt Pegaspargase, 2500IU/m², d9, im Platinum, 20mg/m² d10 d11, ivgtt After the treatment, patients will be given disease specific chemotherapy regimen to treat lymphoma according to patient's different lymphoma subtype.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | All enrolled patients will receive a regimen containing Ruxilitinib, Etoposide, Dexamethasone, Gemcitabine, Pasparase and Platinum for 28 days. The specific medication is as follows:
Ruxilitinib 10 mg, bid, d1-28, P.O. Etoposide 100mg per week, two weeks, ivgtt Dexamethasone, 15mg/(m²·d)，d1-12，10 mg/ (m²·d) ，d13-14，5 mg/ (m²·d) ，d15-21，2.5mg/(m²·d)，d22-28，ivgtt or P.O.
Gemcitabine, 0.5 g/m², d8, ivgtt Pegaspargase, 2500IU/m², d9, im Platinum, 20mg/m² d10 d11, ivgtt After the treatment, patients will be given disease specific chemotherapy regimen to treat lymphoma according to patient's different lymphoma subtype. Receives: Drug: Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR of hemophagocytic syndrome
Objective remission rate of hemophagocytic syndrome
Measured: 28 days
Secondary outcomes (4)
PFS
Progression-free survival
Measured: up to 24 months
ORR of lymphoma
Objective remission rate of lymphoma
Measured: up to 24 months
OS
Overall Survival
Measured: up to 24 months
ADR
Adverse Reaction Rate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start30 May 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingzhi Zhang, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yu Chang, Pro.Dr., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999878
- Sponsor's protocol ID
- hnslblzlzx20210601
- Acronym
- RUE-DDGP
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Ruxolitinib Phosphate Tablets and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome.
- ClinicalTrials.gov ID
- NCT04999878
- Acronym / sponsor ID
- RUE-DDGP / hnslblzlzx20210601
- Conditions
- Hemophagocytic Syndrome, T/NK-Cell Lymphoma
- Keywords
- ruxolitinib, Lymphoma-associated Hemophagocytic Syndrome, Etoposide, Dexamethasone, Pegaspargase, Gemcitabine, cis-platinum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Aug 2021 (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.
To observe the efficacy and safety of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy of T cell lymphoma and NK/T cell lymphoma-associated hemophagocytic syndrome.
Detailed description
This is an open, one-arm, prospective clinical collaborative study. This study is aimed to observe the efficacy and safety of the new combined therapy of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy patients with primary central nervous system lymphoma. A total of 30 patients plan to participate in the study. The primary endpoint is objective remission rate (ORR) of hemophagocytic syndrome, and the secondary endpoints include progression-free survival (PFS) , objective remission rate (ORR) of lymphoma, overall survival (OS), and adverse events(ADR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinumAll enrolled patients will receive a regimen containing Ruxilitinib, Etoposide, Dexamethasone, Gemcitabine, Pasparase and Platinum for 28 days. The specific medication is as follows: Ruxilitinib 10 mg, bid, d1-28, P.O. Etoposide 100mg per week, two weeks, ivgtt Dexamethasone, 15mg/(m²·d)，d1-12，10 mg/ (m²·d) ，d13-14，5 mg/ (m²·d) ，d15-21，2.5mg/(m²·d)，d22-28，ivgtt or P.O. Gemcitabine, 0.5 g/m², d8, ivgtt Pegaspargase, 2500IU/m², d9, im Platinum, 20mg/m² d10 d11, ivgtt After the treatment, patients will be given disease specific chemotherapy regimen to treat lymphoma according to patient's different lymphoma subtype. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathologically proven T-cell lymphoma or NK/ T-cell lymphoma;
- Comply with HLH-2004 diagnostic criteria;Hemophagocytic syndrome can be diagnosed when either of the following two criteria is met:
- Ages 14-75 years.
- Expected survival of more than 1 week.
- Patients with left ventricular ejection fraction > 50%, no major bleeding of active internal organs (digestive tract, lung, brain, etc.), and oxygenation index > 250.
Key exclusion criteria (10 listed)
- Three or more drugs including ruxolitinb, etoposide, pemasparase, gemcitabine or cisplatin were used simultaneously in the previous 28 days.
- Pregnant or lactating women and patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this study. If the patient was male, they refused to use adequate contraception or sperm donation during the study period and for 3 months after the last study of lymphoma-related chemotherapy drugs.
- Allergic to any medication in the program.
- Grade III or IV heart disease based on the New York Heart Association (NYHA) score.
- Major active bleeding of internal organs (including gastrointestinal bleeding, alveolar bleeding, intracranial bleeding, etc.).
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 |
|---|---|---|
| Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinumAll enrolled patients will receive a regimen containing Ruxilitinib, Etoposide, Dexamethasone, Gemcitabine, Pasparase and Platinum for 28 days. The specific medication is as follows: Ruxilitinib 10 mg, bid, d1-28, P.O. Etoposide 100mg per week, two weeks, ivgtt Dexamethasone, 15mg/(m²·d)，d1-12，10 mg/ (m²·d) ，d13-14，5 mg/ (m²·d) ，d15-21，2.5mg/(m²·d)，d22-28，ivgtt or P.O. Gemcitabine, 0.5 g/m², d8, ivgtt Pegaspargase, 2500IU/m², d9, im Platinum, 20mg/m² d10 d11, ivgtt After the treatment, patients will be given disease specific chemotherapy regimen to treat lymphoma according to patient's different lymphoma subtype. | Drug | treatment group |
Primary outcome
ORR of hemophagocytic syndrome
Time frame: 28 days
Objective remission rate of hemophagocytic syndrome
4 secondary outcomes
PFS
Time frame: up to 24 months
ORR of lymphoma
Time frame: up to 24 months
OS
Time frame: up to 24 months
ADR
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
Related trials for Hemophagocytic Syndrome
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.
Yu Chang, Pro.Dr. principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum in people with Hemophagocytic Syndrome and T/NK-Cell Lymphoma, run by Zhengzhou University 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 10 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 11 Aug 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mingzhi Zhang, Pro.Dr. (13838565629, Mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR of hemophagocytic syndrome (time frame: 28 days). 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 11 Aug 2021.