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To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.
This is a prospective, open,investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide,cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CODOX-M/IVAC | Combination Product | Given ivgtt |
| |
| Decitabine |
| Measure | Description | Time Frame |
|---|---|---|
| RR | Responder Rate | up to 2 months |
| TTP | Time To Progression | up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | up to 2 months |
| MST | Median Survival Time | up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi zhang, Pro,Dr | Contact | 13838565629 | Mingzhi_zhang@126.com | |
| Mingzhi zhang | Contact | 13838565629 | Mingzhi_zhang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingzhi zhang | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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| Drug |
Given ivgtt |
|
|
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |