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| Name | Class |
|---|---|
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin, response | Experimental | relapsed or refractory non-Hodgkin's lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin, 130 mg per square meter, on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Toxicity Grade by Patient | graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0 | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheolwon Suh, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18839172 | Result | Sym SJ, Lee DH, Kang HJ, Nam SH, Kim HY, Kim SJ, Eom HS, Kim WS, Suh C. A multicenter phase II trial of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin for patients with primary refractory/relapsed aggressive non-Hodgkin's lymphoma. Cancer Chemother Pharmacol. 2009 Jun;64(1):27-33. doi: 10.1007/s00280-008-0847-y. Epub 2008 Oct 7. |
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Patients with symptomatic central nervous system involvement and pregnant or breastfeeding women were excluded. Patients with grade 2 or more peripheral neuropathy at the time of study entry were also excluded.
A total of 27 patients were enrolled between April and December 2006 from eight institutions in South Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESHAOx | The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESHAOx | The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 25 patients who had completed at least 3 cycles of ESHAOx study treatment were analyzed. 2 patients who did not complete 3 cycles of study treatment were excluded from the response analysis. | Posted | Number | pariticipants | up to 24 weeks |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESHAOx | The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| febrile neutropenia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia grade 1 | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheolwon Suh | Asan Medical Center | 82 2 3010 3209 | csuh@amc.seoul.kr |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005047 | Etoposide |
| D008775 | Methylprednisolone |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Worst Toxicity Grade by Patient | graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0 | The 27 patients received a total of 103 cycles of the ESHAOx treatment, with a median number of four cycles per patient. Except one who was lost to follow-up after one cycle, 26 patients were assessable for toxicity. | Posted | Number | participants | up to 24 weeks |
|
|
|
| 1 |
| 26 |
| 26 |
| 26 |
| neutropenia grade 2 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| neutropenia grade 3 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| neutropenia grade 4 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| thrombocytopenia grade 1 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| thrombocytopenia grade 2 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| thrombocytopenia grade 3 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| thrombocytopenia grade 4 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Title | Measurements |
|---|---|
|
| Grade 4 neutropenia |
|
| Grade 1 thrombocytopenia |
|
| Grade 2 thrombocytopenia |
|
| Grade 3 thrombocytopenia |
|
| Grade 4 thrombocytopenia |
|