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The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.
Chemotherapy-induced nausea and vomiting (CINV) is a serious complication of treatments of hematological malignancies. Although aprepitant has been shown to control CINV in highly emetogenic therapies for solid tumors, the antiemetic effect of aprepitant in hematological chemotherapies is still not clear. In this multi-central perspective randomized controlled study, the investigators are trying to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant Arm | Experimental | Tropisetron 5mg(Day1-6)+ Dexamethasone 10mg(Day1-6)+ Aprepitant125mg(Day1-2)、80mg(Day3-6) |
|
| Control Arm | Active Comparator | Tropisetron 5mg(Day1-6)+ Dexamethasone 10mg(Day1-6) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tropisetron | Drug | Tropisetron Hydrochloride Injection 5mg (Day 1-6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall complete response (no emesis and no rescue therapy) | During and post chemotherapy (0-120 h) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to initial neutrophil engraftment | Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10^9/L | 30 days post-transplantation |
| Time to initial platelet recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhu, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D008223 | Lymphoma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077526 | Tropisetron |
| D003907 | Dexamethasone |
| C004180 | dexamethasone 21-phosphate |
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexamethasone | Drug | Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6) |
|
|
| Aprepitant | Drug | Aprepitant 125mg (Day1-2), 80mg (Day 3-6) |
|
|
Time to initial platelet recovery is defined as 1st of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10^9/L with no platelet transfusion in the prior 7 days.
| 30 days post-transplantation |
| Quality of Life | During and post chemotherapy (0-120 h) |
| Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy. | 30 days |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |