- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04999878
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. (RUE-DDGP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450052
- Recruiting
- Oncology Department of The First Affiliated Hospital of Zhengzhou University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
A. 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.
B. 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.
IV. 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.
V. 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).
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: treatment group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR of hemophagocytic syndrome
Time Frame: 28 days
|
Objective remission rate of hemophagocytic syndrome
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: up to 24 months
|
Overall Survival
|
up to 24 months
|
PFS
Time Frame: up to 24 months
|
Progression-free survival
|
up to 24 months
|
ORR of lymphoma
Time Frame: up to 24 months
|
Objective remission rate of lymphoma
|
up to 24 months
|
ADR
Time Frame: up to 24 months
|
Adverse Reaction Rate
|
up to 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yu Chang, Pro.Dr., The First Affiliated Hospital of Zhengzhou University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Disease
- Histiocytosis, Non-Langerhans-Cell
- Histiocytosis
- Lymphoma, T-Cell
- Lymphoma
- Syndrome
- Lymphoma, Extranodal NK-T-Cell
- Lymphohistiocytosis, Hemophagocytic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Gemcitabine
- Dexamethasone
- Etoposide
- Cisplatin
- Pegaspargase
Other Study ID Numbers
- hnslblzlzx20210601
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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