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This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All enrolled patients. | All patient who signed the consent form for participation to the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvelisib | Drug | This is a real-word. The treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) | The safety of the drug was evaluated by NCI-CTC AE 5.0 standard. | From the first day of medication to 30 days after the last dose] |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Defined as the best response of complete response/remission (CR) or partial response/remission (PR). | up to 6 cycles of therapy (each cycle is 28 days)] |
| Duration of remission (DOR) |
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Inclusion Criteria:
To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;
Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));
Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:
Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;
Must have adequate organ function defined by the following laboratory parameters:
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Patients with infections should be treated first and then considered for enrollment when the infection is under control.
Exclusion Criteria:
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Population who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, PhD | Contact | 021-64370045 | zwl_trial@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao, PhD | Ruijin Hospital | Principal Investigator |
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|
Time from reaching CR or PR for the first time to disease progression.
| 4 year |
| Progression-Free-Survival (PFS) | From date of inclusion to date of progression, relapse, or death from any cause. | 4 year |
| Overall survival (OS) | From the date of inclusion to date of death, irrespective of cause. | 4 year |
| Quality of life (QOL) | The quality of life scale, ranging from 0 to 100. A score of 0 represents the worst health and a score of 100 represents the best health. | 4 year |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
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| ID | Term |
|---|---|
| C586691 | duvelisib |
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