Condition or disease | Intervention/treatment | Phase |
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Lymphoma, Large B-Cell, Diffuse | Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab | Phase 2 |
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 |
Arm | Intervention/treatment |
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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.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Qingqing Cai, MD | 0086-20-87342823 | caiqq@sysucc.org.cn |
China, Guangdong | |
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting |
Guangzhou, Guangdong, China, 510000 | |
Contact: Zhihua LI, MD |
Tracking Information | |||||
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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 |
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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.
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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 | ||||
* 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 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |