Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase 2 trial studies the efficacy and safety of PD-1 inhibitor monotherapy or PD-1 inhibitor with GVD (Gemcitabine, Vinorelbine and Doxorubicin Liposome) regimen for relapsed or refractory classical Hodgkin lymphoma (CHL) patients who failed the first-line induction therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Inhibitor or PD-1 Inhibitor with GVD | Experimental | All patients receive PD-1 Inhibitor on day 1. Treatment cycles repeat every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR or PR receive PD-1 Inhibitor for another 3 cycles. Patients with PD or SD receive PD-1 Inhibitor plus GVD (gemcitabine, vinorelbine and doxorubicin liposome) regimen every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR after 6 cycles of PD-1 Inhibitor treatment can receive radiotherapy or ASCT, which is determined by investigators. Patients with PR receive 2-4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with PD or SD receive 4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with confirmed CR or PR after PD-1 Inhibitor plus GVD regimen can receive radiotherapy or ASCT, which is determined by investigators. Patients with PD or SD quit the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | PD-1 Inhibitor, intravenous drip, d1. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response rate | Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | 2 years |
| Progression Free Survival | The time from the start of treatment to the progression of the tumor or death (due to any cause). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qingqing Cai, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, | Recruiting | Guangzhou | Guangdong | 51000 | China |
Not provided
| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome |
| Drug |
PD-1 Inhibitor, intravenous drip, d1; Gemcitabine, 1000mg/m2, intravenous drip, d1,d8; Vinorelbine, 50mg/m2, PO, d1,d8; Doxorubicin Liposome, 30mg/m2, intravenous drip, d1; |
|
| 5 years |
| Overall Survival | The time from the start of treatment to time of death (due to any cause). | 5 years |
| Duration of Response | The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause). | 5 years |
| Time to Response (TTR) | The time from the start of treatment to the first assessment of complete remission or partial remission. | 2 years |
| Percentage of Participants With Adverse Events | Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0 | 2 years |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The First Affiliated Hospital of Guangdong Pharmaceutical University | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |