A Phase 2 interventional study of Oxaliplatin in Non-Hodgkin's Lymphoma, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by Asan Medical Center · Phase 2, Interventional, and Treatment
Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.
Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. ESHAP, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. But it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory NHL.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 27 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
relapsed or refractory non-Hodgkin's lymphoma
Drug: Oxaliplatin
Oxaliplatin, 130 mg per square meter, on day 1
Also known as: etoposide, 40 mg per square meter on days 1 to 4,, methylprednisolone, 500 mg on days 1 to 5,, cytarabine, 2 g per square meter on day 5
Overall Response Rate
The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
Time frame: up to 24 weeks
Worst Toxicity Grade by Patient
graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0
Time frame: up to 24 weeks
A total of 27 patients were enrolled between April and December 2006 from eight institutions in South Korea.
| Milestone | ESHAOx |
|---|---|
| Started | 27 |
| Completed | 25 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Death | 1 |
The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
| pariticipants | ESHAOx |
|---|---|
| Overall Response Rate | 17 |
graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0
| participants | ESHAOx |
|---|---|
| Grade 1 neutropenia | 3 |
| Grade 2 neutropenia | 3 |
| Grade 3 neutropenia | 2 |
| Grade 4 neutropenia | 13 |
| Grade 1 thrombocytopenia | 4 |
| Grade 2 thrombocytopenia | 3 |
| Grade 3 thrombocytopenia | 3 |
| Grade 4 thrombocytopenia | 6 |
Collected over 9 months. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ESHAOx | — | 1/26 (3.8%) | 26/26 (100%) |
| Event | ESHAOx |
|---|---|
| febrile neutropeniaInfections and infestations | 1/26 |
| Event | ESHAOx |
|---|---|
| neutropenia grade 4Blood and lymphatic system disorders | 13/26 |
| thrombocytopenia grade 4Blood and lymphatic system disorders | 6/26 |
| thrombocytopenia grade 1Blood and lymphatic system disorders | 4/26 |
| neutropenia grade 1Blood and lymphatic system disorders | 3/26 |
| neutropenia grade 2Blood and lymphatic system disorders | 3/26 |
| thrombocytopenia grade 2Blood and lymphatic system disorders | 3/26 |
| thrombocytopenia grade 3Blood and lymphatic system disorders | 3/26 |
| neutropenia grade 3Blood and lymphatic system disorders | 2/26 |
| Age, Categorical(Participants) | ESHAOx |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 7 |
| Age, Continuous(years) | ESHAOx |
|---|---|
| Mean | 55.2 ± 10.8 |
| Sex: Female, Male(Participants) | ESHAOx |
|---|---|
| Female | 10 |
| Male | 17 |
| Region of Enrollment(participants) | ESHAOx |
|---|---|
| Korea, Republic of | 27 |
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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Asan Medical Center