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出境医 / 临床实验 / Biomarker Guided Treatment in DLBCL
Biomarker Guided Treatment in DLBCL
Study Description
Brief Summary:
This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diffuse Large B Cell Lymphoma | Drug: Cyclophosphamide Drug: Rituximab Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Ibrutinib Drug: Lenalidomide Drug: chidamide Drug: decitabine | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 128 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL |
| Actual Study Start Date : | July 17, 2019 |
| Estimated Primary Completion Date : | July 1, 2021 |
| Estimated Study Completion Date : | June 1, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: RCHOP |
Drug: Cyclophosphamide
750mg/m2 day 1
Drug: Rituximab 375mg/m2 day 0
Drug: Doxorubicin 50mg/m2 day 1
Drug: Vincristine 1.4mg/m2, max 2mg day 1
Drug: Prednisone 60mg/m2, max 100mg day 1-5
|
| Experimental: RCHOPX |
Drug: Cyclophosphamide
750mg/m2 day 1
Drug: Rituximab 375mg/m2 day 0
Drug: Doxorubicin 50mg/m2 day 1
Drug: Vincristine 1.4mg/m2, max 2mg day 1
Drug: Prednisone 60mg/m2, max 100mg day 1-5
Drug: Ibrutinib 420mg/day qd
Drug: Lenalidomide 25mg day1-10
Drug: chidamide 20mg day 1,4,8,11
Drug: decitabine decitabine 10mg/m2 day-5 to day-1
|
Outcome Measures
Primary Outcome Measures :
- complete response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]
Secondary Outcome Measures :
- progression free survival [ Time Frame: 2 year ]
- overall survival [ Time Frame: 2 year ]
- overall response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Up to 30 days after completion of study treatment ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
- ECOG 0,1,2
- Life expectancy>6 months
- Informed consented
- IPI>1
Exclusion Criteria:
- Chemotherapy before
- Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS lymphoma
- LVEF≤50%
- Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Contacts and Locations
Contacts
| Contact: WL Z, MD PhD | 64370045 ext 610707 | zhao.weili@yahoo.com |
Locations
| China, Shanghai | |
| Ruijin hospital | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Pp X, MD, PhD 86-21-64370045 ext 610707 xpproc@msn.com | |
| Principal Investigator: WL Z, MD, PhD | |
| Sub-Investigator: PP X, MD, PhD | |
Sponsors and Collaborators
Ruijin Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 17, 2019 | ||||
| First Posted Date ICMJE | July 19, 2019 | ||||
| Last Update Posted Date | November 19, 2020 | ||||
| Actual Study Start Date ICMJE | July 17, 2019 | ||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
complete response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ] | ||||
| 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 | Biomarker Guided Treatment in DLBCL | ||||
| Official Title ICMJE | A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL | ||||
| Brief Summary | This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Diffuse Large B Cell Lymphoma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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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 |
128 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 1, 2023 | ||||
| Estimated Primary Completion Date | July 1, 2021 (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 80 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 | NCT04025593 | ||||
| Other Study ID Numbers ICMJE | Guidance-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Zhao Weili, Ruijin Hospital | ||||
| Study Sponsor ICMJE | Ruijin Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Ruijin Hospital | ||||
| Verification Date | November 2020 | ||||
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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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