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To observe the safety, tolerability and clinical effects of crizotinib combined with etoposide capsule followed by autologous hematopoietic stem cell transplantation (Auto-HSCT) for patients with relapsed and refractory ALK-positive Anaplastic Large Cell Lymphoma.
This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of crizotinib combined with etoposide followed by autologous hematopoietic stem cell transplantation for relapsed and refractory ALK-positive ALCL. A total of 20 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed and refractory ALK-positive ALCL will be treated with crizotinib plus etoposide capsules followed by autologous hematopoietic stem cell transplantation. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizotinib + etoposide capsule+Auto-HSCT | Experimental | Crizotinib and etoposide capsule followed by autologous hematopoietic stem cell transplantation. Crizotinib: 250mg, bis in die (BID), PO. Etoposide capsule:50mg, quaque die (QD), PO, d1-10,21days for one cycle. Patients will receive the treatment of crizotinib and etoposide capsule, and those who have achieved CR(complete response)or VGPR(very good partial response)will undergo the Auto-HSCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | 250mg, BID, PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Responder Rate | up to 24 months |
| PFS | Progression Free Survival | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | up to 24 months |
| adverse events | Number of patients with adverse events | up to 24 months |
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Criteria: Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi zhang, Pro,Dr | 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 |
|---|---|
| D000077547 | Crizotinib |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| Etoposide Capsule |
| Drug |
50mg, QD, PO, d1-10,21days for one cycle |
|
| Auto-HSCT | Procedure | Auto-HSCT will be performed with patients who have achieved CR or VGPR. |
|
| D011725 |
| Pyridines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |