Hemophagocytic Lymphohistiocytosis
Conditions
Keywords
pegylated liposomal doxorubicin
Brief summary
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.
Interventions
DRUGPegylated liposomal doxorubicin
35mg/m² ivgtt on day 1
DRUGEtoposide
100mg/m² ivgtt on day 1
DRUGMethylprednisolone
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,
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Time Frame: 1 years | complete response (CR) and partial response (PR) rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of lymphoma | Time Frame: 1 years | complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.) |
| Progression Free Survival | Time Frame: 1 years | from date of inclusion to date of progression, relapse, or death from any cause Overall Survival |
| Overall Survival | Time Frame: 1 years | from the date of inclusion to date of death, irrespective of cause Adverse Events |
| Adverse Events | Time Frame: 1 years | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure |
Countries
China
Contacts
Primary ContactZhao Wang, PHD
Outcome results
None listed