Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.
NCT ID: NCT04077905
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2019-08-31
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DEP regimen
pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
Pegylated liposomal doxorubicin
35mg/m² ivgtt on day 1
Etoposide
100mg/m² ivgtt on day 1
Methylprednisolone
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,
Interventions
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Pegylated liposomal doxorubicin
35mg/m² ivgtt on day 1
Etoposide
100mg/m² ivgtt on day 1
Methylprednisolone
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,
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
2 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Zhao Wang
Principal Investigator
Locations
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Beijing Friendship Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CSPC-DMS-HLH-01
Identifier Type: -
Identifier Source: org_study_id
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