Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia | Biological: Ex-vivo Expanded γδ T Lymphocytes | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia: a Single-center, Open-label, Single-arm Clinical Study. |
Estimated Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | January 1, 2023 |
Arm | Intervention/treatment |
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Experimental: Ex-vivo Expanded γδ T Lymphocytes
Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2*10^6, 4*10^6, 8*10^6 of cells per kg of body weight).
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Biological: Ex-vivo Expanded γδ T Lymphocytes
Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2*10^6, 4*10^6, 8*10^6 of cells per kg of body weight).
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yu Hu, M.D. Ph.D | 86-13986183871 | dr_huyu@126.com | |
Contact: Heng Mei, M.D. Ph.D | 86-13886160811 | hmei@hust.edu.cn |
China, Hubei | |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
Wuhan, Hubei, China, 430022 | |
Contact: Yu Hu, M.D., Ph.D 86-13986183871 dr_huyu@126.com | |
Contact: Heng Mei, M.D., Ph.D 86-13886160811 hmei@hust.edu.cn |
Principal Investigator: | Heng Mei, M.D. Ph.D | Wuhan Union Hospital, China |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 2, 2019 | ||||||||
First Posted Date ICMJE | July 5, 2019 | ||||||||
Last Update Posted Date | August 7, 2019 | ||||||||
Estimated Study Start Date ICMJE | September 1, 2019 | ||||||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia | ||||||||
Official Title ICMJE | Efficacy and Safety of Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia: a Single-center, Open-label, Single-arm Clinical Study. | ||||||||
Brief Summary | This study investigates the potential curative properties of ex-vivo expanded gamma delta T-cells obtained from a blood-related donor for patients with relapsed or refractory acute myeloid leukemia. | ||||||||
Detailed Description | This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T-lymphocytes in patients with relapsed or refractory acute myeloid leukemia. PBMCs will be separated from peripheral blood of suitable donors. After making them potential cancer killer γδ T Cells, they will be infused to the patients as an immunotherapy treatment. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Myeloid Leukemia | ||||||||
Intervention ICMJE | Biological: Ex-vivo Expanded γδ T Lymphocytes
Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2*10^6, 4*10^6, 8*10^6 of cells per kg of body weight).
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Study Arms ICMJE | Experimental: Ex-vivo Expanded γδ T Lymphocytes
Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2*10^6, 4*10^6, 8*10^6 of cells per kg of body weight).
Intervention: Biological: Ex-vivo Expanded γδ T Lymphocytes
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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 |
38 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 1, 2023 | ||||||||
Estimated Primary Completion Date | July 1, 2022 (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 75 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 | NCT04008381 | ||||||||
Other Study ID Numbers ICMJE | WHUH-2009-V010 | ||||||||
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 | MEI HENG, Wuhan Union Hospital, China | ||||||||
Study Sponsor ICMJE | Wuhan Union Hospital, China | ||||||||
Collaborators ICMJE | Jinan University, China | ||||||||
Investigators ICMJE |
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PRS Account | Wuhan Union Hospital, China | ||||||||
Verification Date | August 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |