| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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).
|
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).
|
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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).
|
||||||||
| 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 | ||||||||
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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 |
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 | ||||||||
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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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