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This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.
randomized, double-blind, two arms , multicenter
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) | Experimental | Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses. |
|
| Treatment (placebo, etoposide, ifosfamide, carboplatin) | Experimental | Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Biological | IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 44months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronghua Zhang | Contact | 15267110561 | ronghua.zhang@innoventbio.com | |
| Hui Zhou | Contact | 86-021-31837200 | hui.zhou@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| Carboplatin |
| Drug |
IV |
|
| Etoposide | Drug | IV |
|
| Ifosfamide | Drug | IV |
|
| Placebo | Drug | IV |
|
| Carboplatin | Drug | IV |
|
| Etoposide | Drug | IV |
|
| Ifosfamide | Drug | IV |
|
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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