Clinical trial · Interventional
Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.
A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis
NCT04077905CI-TRIAL-00040447unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide | Drug | Etoposide | ALIAS |
| Methylprednisolone | Drug | — | UNRESOLVED |
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEP regimen
- description
- pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
- interventionNames
- Drug: Pegylated liposomal doxorubicin
- Drug: Etoposide
- Drug: Methylprednisolone
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Time Frame: 1 years
- description
- complete response (CR) and partial response (PR) rates
Secondary outcomes (4)
- measure
- Response rate of lymphoma
- timeFrame
- Time Frame: 1 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis. * 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: * 1.Heart function above grade II (NYHA). * 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.
References
Publications (1)
- DERIVEDPi 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. PMID 35852619