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.

NCT04999878 | Unknown Phase 4

• 1 other identifier: hnslblzlzx20210601
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemophagocytic Syndrome; T/NK-Cell Lymphoma

Keywords

ruxolitinib; Lymphoma-associated Hemophagocytic Syndrome; Etoposide; Dexamethasone; Pegaspargase; Gemcitabine; cis-platinum

Outcome Measures

Primary Outcomes (1)

• ORR of hemophagocytic syndrome

  Objective remission rate of hemophagocytic syndrome

  28 days

Secondary Outcomes (4)

• PFS

  up to 24 months

• ORR of lymphoma

  up to 24 months

• OS

  up to 24 months

• ADR

  up to 24 months

Study Arms (1)

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.

Drug: Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum

Interventions

Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum DRUG

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.

treatment group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic; Lymphoma, Extranodal NK-T-Cell

Interventions

ruxolitinib; Etoposide; Dexamethasone; Gemcitabine; pegaspargase; Cisplatin

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yu Chang, Pro.Dr.

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi Zhang, Pro.Dr.

CONTACT

13838565629; Mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital of Zhengzhou University

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: May 30, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

CN (1)