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This is an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma
. The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and Piamprizumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination of Azacytidine, Bendamustine and Piamprizumab | Experimental | combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacytidine, Bendamustine and Piamprizumab | Drug | Azacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: treatment-related adverse events (AEs) | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The ORR is defined as the proportion of patients with a best overall disease response, including complete response (CR) and partial response (PR). | 6 month |
| Complete Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Han, M.D. | Contact | +861055499341 | hanwdrsw@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotherapeutic Department of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
| 6 month |
| Biotherapeutic Department of Chinese PLA General Hospital | Recruiting | Beijing | China |
|
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |