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出境医 / 临床实验 / GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
Study Description
Brief Summary:
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single Arm, Phase II Study |
| Actual Study Start Date : | July 15, 2019 |
| Estimated Primary Completion Date : | July 15, 2023 |
| Estimated Study Completion Date : | December 15, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: GVD with or without R
Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
|
Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
|
Outcome Measures
Primary Outcome Measures :
- ORR [ Time Frame: 4-years ]
Secondary Outcome Measures :
- success rates in autologous stem cell mobilization [ Time Frame: 4-years ]
- PFS [ Time Frame: 4-years ]
- EFS [ Time Frame: 4-years ]
- OS [ Time Frame: 4-years ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- biopsy proved CD20+ DLBCL;
- previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
- at least one evaluable lesion；
- ECOG PS 0-1;
- 18-65 years;
- proper functioning of the major organs.
Exclusion Criteria:
- involvement of central nervous system;
- with other malignancy;
- patients receiving or received drug of other clinical trial within 30 days；
- previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
- patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
- grade 2 or more peripheral neuropathy.
Contacts and Locations
Contacts
| Contact: Qingqing Cai, MD | 0086-20-87342823 | caiqq@sysucc.org.cn |
Locations
| China, Guangdong | |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Zhihua LI, MD | |
Sponsors and Collaborators
Sun Yat-sen University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 13, 2019 | ||||
| First Posted Date ICMJE | July 16, 2019 | ||||
| Last Update Posted Date | August 6, 2019 | ||||
| Actual Study Start Date ICMJE | July 15, 2019 | ||||
| Estimated Primary Completion Date | July 15, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
ORR [ Time Frame: 4-years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL | ||||
| Official Title ICMJE | GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single Arm, Phase II Study | ||||
| Brief Summary | The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE | Lymphoma, Large B-Cell, Diffuse | ||||
| Intervention ICMJE | Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
|
||||
| Study Arms ICMJE | Experimental: GVD with or without R
Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
Intervention: Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
48 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 15, 2023 | ||||
| Estimated Primary Completion Date | July 15, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04021992 | ||||
| Other Study ID Numbers ICMJE | B2019-088 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Qingqing Cai, Sun Yat-sen University | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Sun Yat-sen University | ||||
| Verification Date | August 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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