Acute Myeloid LeukemiaPhase 1NCT04008381
Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia
A Phase 1 study testing Ex-vivo Expanded γδ T Lymphocytes in people with Acute Myeloid Leukemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Ex-vivo Expanded γδ T Lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
- Relapsed or refractory AML. A. AML relapse after intensive chemotherapy; B. AML relapse after allogeneic HCT; C. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine); D. No response to at least 4 cycles of low intensity therapy; E. AML refractory to 2 cycles of induction chemotherapy.
- Presence of > 5% of blasts in bone marrow or peripheral blood smear
- Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
- Considered suitable for lymphodepleting chemotherapy
- The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
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- Patient's main organs function well. A. Liver function: ALT/AST < 3 times the upper limit of normal (ULN); B. total bilirubin≤34.2μmol/L; C. Renal function: Creatinine < 220μmol/L; D. Pulmonary function: Indoor oxygen saturation≥95%; E. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%;
- Life expectancy of at least 3 months
- Patient ECOG score≤2, Estimated survival time≥3 months.
- Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.
- The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia).
- Patient able to understand and sign written informed consent
- Age 18 years up to the age of 75 (≤ 75)
Who cannot join
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- Male or female with a conception plan in the past 1 years.
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- Uncontrolled infectious disease within 4 weeks prior to enrollment.
- Active hepatitis B/C virus.
- HIV infected patients.
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- Suffering from a serious autoimmune disease or immunodeficiency disease.
- The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
- The patient participated in other clinical trials within 6 weeks prior to enrollment.
- Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- Have a history of epilepsy or other central nervous system diseases.
- Having drug abuse/addiction.
- According to the researcher's judgment, the patient has other unsuitable grouping conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yu Hu, M.D., Ph.D, 86-13986183871, dr_huyu@126.com
Heng Mei, M.D., Ph.D, 86-13886160811, hmei@hust.edu.cn
About this study
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.
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Ex-vivo Expanded γδ T Lymphocytes
- Keywords
- gamma-delta T, Refractory/Relapsed
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex-vivo Expanded γδ T LymphocytesBiological
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 group | Role | What they receive |
|---|---|---|
| Ex-vivo Expanded γδ T Lymphocytes | Experimental | 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). Receives: Biological: Ex-vivo Expanded γδ T Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-months remission rate
Number of patients reaching Complete Remission (CR) according to National Comprehensive Cancer Network (NCCN, Version 1.2015).
Measured: 4 months
Number of participants with adverse events (AEs)
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
Measured: 3 years
Secondary outcomes (5)
Overall survival
OS was calculated from the first infusion to death or last follow-up (censored).
Measured: 3 years
Event-free survival
EFS was calculated from the first infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).
Measured: 3 years
Relapse-free survival
RFS was calculated from the first infusion to relapse or last visit (censored).
Measured: 3 years
Quantity of gamma-delta T cells in bone marrow cells and peripheral blood cells
Persistence of γδ T cells assessed by number and phenotype of γδ T cells using flow cytometry assay in peripheral blood and bone marrow from patients
Measured: 3 years
lymphocyte subsets function assessment of bone marrow cells and peripheral blood cells
Assessment of lymphocyte subsets function using flow cytometry assay in peripheral blood and bone marrow from patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan University, China
- Responsible party
- Principal investigator, MEI HENG, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Heng Mei, M.D. Ph.D, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008381
- Sponsor's protocol ID
- WHUH-2009-V010
- Status last verified
- Aug 2019
- First submitted
- 2 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04008381
- Acronym / sponsor ID
- WHUH-2009-V010
- Conditions
- Acute Myeloid Leukemia
- Keywords
- gamma-delta T, Refractory/Relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Jinan University, China
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ex-vivo Expanded γδ T Lymphocytes | Experimental | Biological: Ex-vivo Expanded γδ T LymphocytesPatients 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
- Relapsed or refractory AML. A. AML relapse after intensive chemotherapy; B. AML relapse after allogeneic HCT; C. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine); D. No response to at least 4 cycles of low intensity therapy; E. AML refractory to 2 cycles of induction chemotherapy.
- Presence of > 5% of blasts in bone marrow or peripheral blood smear
- Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
- Considered suitable for lymphodepleting chemotherapy
Key exclusion criteria (13 listed)
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- Male or female with a conception plan in the past 1 years.
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- Uncontrolled infectious disease within 4 weeks prior to enrollment.
- Active hepatitis B/C virus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex-vivo Expanded γδ T LymphocytesPatients 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 |
Primary outcome
Four-months remission rate
Time frame: 4 months
Number of patients reaching Complete Remission (CR) according to National Comprehensive Cancer Network (NCCN, Version 1.2015).
Number of participants with adverse events (AEs)
Time frame: 3 years
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
5 secondary outcomes
Overall survival
Time frame: 3 years
Event-free survival
Time frame: 3 years
Relapse-free survival
Time frame: 3 years
Quantity of gamma-delta T cells in bone marrow cells and peripheral blood cells
Time frame: 3 years
lymphocyte subsets function assessment of bone marrow cells and peripheral blood cells
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heng Mei, M.D. Ph.D principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ex-vivo Expanded γδ T Lymphocytes in people with Acute Myeloid Leukemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Hu, M.D. Ph.D (86-13986183871, dr_huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four-months remission rate (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.