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High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChiCGB | Experimental | Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. |
|
| BEAM | Active Comparator | Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | 30 mg oral twice weekly for 2 weeks |
| |
| Cladribine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Progression free survival of this group of patients at the end of 2 year | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival of this group of patients at the end of 2 year | 2 years |
| 100 day adverse events (AE) | non-hematologic adverse events @ Day +100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Deyang City | Not yet recruiting | Deyang | Deyang | 618000 | China |
Release after the publication of results of this trial
after the publication of results of this trial
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D017338 | Cladribine |
| D000093542 | Gemcitabine |
| D002066 | Busulfan |
| D002330 | Carmustine |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
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| Drug |
6 mg/m2 intravenously once daily @ Day -7 ~ -3 |
|
| Gemcitabine | Drug | 2500 mg/m2 intravenously @ Day -7, -3 |
|
| Busulfan | Drug | 3.2 mg/kg intravenously once daily @ Day -7 ~ -4 |
|
| Carmustine | Drug | 300 mg/m2 intravenously @ Day -8 |
|
| Etoposide | Drug | 200 mg/m2 intravenously once daily @ Day -7 ~ -4 |
|
| Cytarabine | Drug | 400 mg/m2 intravenously once daily @ Day -7 ~ -4 |
|
| Melphalan | Drug | 140 mg/m2 intravenously @ Day -3 |
|
| Autologous hematopoietic stem cell transplant | Procedure | autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy |
|
| 100 days from transplant |
| 100 day complete response (CR) rate | Complete response @ Day +100 | 100 days from transplant |
| Chengdu Third People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610015 | China |
|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| Chengdu First People's Hospital | Recruiting | Chengdu | Sichuan | 610071 | China |
|
| PLA Western Theater Command General Hospital | Recruiting | Chengdu | Sichuan | 610083 | China |
|
| Dazhou Central Hospital | Not yet recruiting | Dazhou | Sichuan | 635000 | China |
|
| Southwest Medical University | Recruiting | Luzhou | Sichuan | 646000 | China |
|
| Central Hospital of Mianyang City | Recruiting | Mianyang | Sichuan | 621000 | China |
|
| Affiliated Hospital of North Sichuan Medical College | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
|
| Zigong First People's Hospital | Recruiting | Zigong | Sichuan | 643011 | China |
|
| Guangyuan Central Hospital | Recruiting | Guangyuan | Sihcuan | 628099 | China |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001087 | Arabinonucleosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |