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Trial record 8 of 14 for:    mg/m2 | "familial hemophagocytic lymphohistiocytosis"

Ruxolitinib Combined With Dexamethasone for HLH

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ClinicalTrials.gov Identifier: NCT03795909
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Yue, Capital Research Institute of Pediatrics

Brief Summary:
A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Drug: Ruxolitinib Drug: Dexamethasone Phase 1 Phase 2

Detailed Description:
A modified protocol about ruxolitinib combined with dexamethasone which includes oral ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg,5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years). Dexamethasone (10mg/m2.d) delayes for the first 2 weeks (form week 1 to 2),(5mg/m2.d) from week 3 to 4,(2.5mg/m2.d) from week 5 to 6),1.25mg/m2.d for week 7,and dropped off on week 8. Every 2 weeks, patients can be evaluated based the diagnosed index

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2022


Arm Intervention/treatment
Experimental: Ruxolitinib and Placebo
Ruxolitinib 2.5 mg twice daily by oral
Drug: Ruxolitinib
Ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg,5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years)
Other Name: Jakafi

Drug: Dexamethasone
Dexamethasone (10mg/m2.d) delayes for the first 2 weeks(form week 1 to 2),(5mg/m2.d) from week 3 to 4,(2.5mg/m2.d) from week 5 to 6),1.25mg/m2.d for week 7,and dropped off on week 8.
Other Name: Hormone

Placebo Comparator: Placebo and Ruxolitinib
Sugar pill 2.5 mg twice daily by oral
Drug: Ruxolitinib
Ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg,5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years)
Other Name: Jakafi

Drug: Dexamethasone
Dexamethasone (10mg/m2.d) delayes for the first 2 weeks(form week 1 to 2),(5mg/m2.d) from week 3 to 4,(2.5mg/m2.d) from week 5 to 6),1.25mg/m2.d for week 7,and dropped off on week 8.
Other Name: Hormone




Primary Outcome Measures :
  1. Severity of disease [ Time Frame: 2 weeks ]
    Serum ferritin>2000ng/ml, disease actvie; serum ferritin<2000ng/ml, disease control;


Secondary Outcome Measures :
  1. Axillary temperature [ Time Frame: 2 weeks ]
    36<Axillary temperature<37.2, disease control; 37.2<Axillary temperature<38.2, disease partly control; Axillary temperature>38.2, disease active



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Secondary and refractory HLH.

Exclusion Criteria:

  • Family HLH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795909


Contacts
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Contact: Yan Yue, MD 8618515238169 ext 8618515238169 adaile123@sina.com
Contact: xiaodong d Shi, MD 8613911601076 ext 8618515238169 18611196921@163.com

Locations
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China, Chaoyang District
Yan Yue Recruiting
Beijing, Chaoyang District, China, 100020
Contact: Yan Yue, MD    8618515238169 ext 8618515238169    18611196921@163.com   
Contact: Yan Yue, MD    8618515238169 ext 8618515238169    adaile123@sina.com   
Principal Investigator: Jia Y Qin, MD         
China
Yan Yue Recruiting
Beijing, China
Contact: xiaodong Shi, MD    008613911601076 ext 8618515238169    adaile123@sina.com   
Contact: Yan Yue, MD    8618515238169 ext 8618515238169    adaile123@sina.com   
Sponsors and Collaborators
Capital Research Institute of Pediatrics
Investigators
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Principal Investigator: Yan Yue, MD Capital Institute of Pediatrics, China

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Responsible Party: Yan Yue, Principal Investigator, Capital Research Institute of Pediatrics
ClinicalTrials.gov Identifier: NCT03795909     History of Changes
Other Study ID Numbers: HLH-DR
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action