Hodgkin's Lymphoma
Conditions
Keywords
Hodgkin's disease, lymphoma, Relapsed, refractory
Brief summary
The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma (HL).
Interventions
DRUGOxaliplatin-based chemotherapy (ESHAOx)
* Etoposide 40 mg/m2, D1-4 * Methylprednisolone 500mg, D1-5 * Cytarabine 2 g/m2, D5 * Oxaliplatin 130 mg/m2, D1
Sponsors
Asan Medical Center
Severance Hospital
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Previously histologically confirmed Hodgkin's lymphoma * Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease * Performance status (ECOG) ≤ 3 * Age ≤ 75 years old * Number of prior chemotherapies: one or two regimens * At least one or more uni-dimensionally measurable lesion(s) defined as; ≥ 2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination * Adequate organ functions defined as; ANC \> 1,500/ul, platelet \> 75,000/ul, transaminases \< 3 X upper normal values; bilirubin \< 2 mg/dL * Written informed consent approved by institutional review board or ethic committee
Exclusion criteria
* Previous high dose chemotherapy with autologous stem cell transplantation or allogeneic stem cell transplantation * Previous chemotherapies with ESHAP regimen * Any other malignancies within the past 5 years except skin basal cell carcinoma or carcinoma in situ of cervix * Other serious illness or medical conditions * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * History of significant neurologic or psychiatric disorders including dementia or seizures * Active uncontrolled infection (viral, bacterial or fungal infection) * Other serious medical illnesses * Pregnancy or breast-feeding, women of childbearing potential not employing adequate contraception * Previous history of drug allergy to one of the drugs in the study regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response rate to ESHAOx chemotherapy | within 3 weeks after the completion of the treatment | To evaluate response rate by Cheson criteria for malignant lymphoma after 3 and 6 cycles of treatment with ESHAOx regimen in patients with refractory or relapsed Hodgkin's lymphoma. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, response duration, toxicity profiles | up to 5 years after the completion of treatment |
Countries
South Korea
Contacts
Primary ContactHyewon Lee, MD
Outcome results
None listed