B-cell Acute Lymphoblastic LeukemiaPhase 1NCT02924753
The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
A Phase 1 study testing Cyclophosphamide, Fludarabine and CART-19 cells in people with B-cell Acute Lymphoblastic Leukemia, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- Cyclophosphamide, Fludarabine and CART-19 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2016to Dec 2019
- 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 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 4 years to 70 years, expected survival > 3 months
- CD19 positive B-cell acute lymphoblastic leukemia
- Karnofsky Performance Status (KPS) >70
- Relapsed after allogeneic or autologous stem cell transplantation (SCT);
- Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
- No serious allergic constitution
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- No other serous diseases that conflicts with the clinical program
- No other cancer history
- No serious mental disorder
- Informed consent is signed by a subject or his lineal relation.
Who cannot join
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases
- Transaminase >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
Trial locations and contacts
1 site in 1 country.
Yongping Song contact
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yongping Song, ph200811@163.com
About this study
Official title: The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.
Read the detailed description
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- Cyclophosphamide, Fludarabine, CART-19 cells
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
FludarabineDrug
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
CART-19 cellsBiological
Also called CD19 specific Chimeric Antigen Receptor T-cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CART-19 | Experimental | patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: CART-19 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety as assessed by the occurrence of study related adverse events.
monitor the occurrence of study related adverse events.
Measured: 6 months
Secondary outcomes (2)
efficacy
anti-tumor activity of CART-19 cells will be determined in a follow-on study
Measured: 2 years
duration of CART-19
Determine duration of in vivo survival of CART-19 cells.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start18 Jul 2016
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- The Beijing Pregene Science and Technology Company, Ltd.
- Responsible party
- Principal investigator, Yongping Song, Henan Cancer Hospital
- Investigators
- Yongping Song, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924753
- Sponsor's protocol ID
- HenanCH080
- Status last verified
- Dec 2017
- First submitted
- 29 Sep 2016
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT02924753
- Acronym / sponsor ID
- HenanCH080
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- The Beijing Pregene Science and Technology Company, Ltd.
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- 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 is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.
Detailed description
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART-19 | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: CART-19 cellspatients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2. |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 4 years to 70 years, expected survival > 3 months
- CD19 positive B-cell acute lymphoblastic leukemia
- Karnofsky Performance Status (KPS) >70
- Relapsed after allogeneic or autologous stem cell transplantation (SCT);
- Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
Key exclusion criteria (8 listed)
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases
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 |
|---|---|---|
| Cyclophosphamidepatients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4). | Drug | CART-19 |
| FludarabineFludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3). | Drug | CART-19 |
| CART-19 cellsAlso: CD19 specific Chimeric Antigen Receptor T-cellsCART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy. | Biological | CART-19 |
Primary outcome
safety as assessed by the occurrence of study related adverse events.
Time frame: 6 months
monitor the occurrence of study related adverse events.
2 secondary outcomes
efficacy
Time frame: 2 years
duration of CART-19
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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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.
Yongping Song contact
Yongping Song study director
Henan Cancer Hospital
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 Cyclophosphamide, Fludarabine and CART-19 cells in people with B-cell Acute Lymphoblastic Leukemia, run by Henan Cancer Hospital 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 10 inclusion and 8 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 29 Dec 2017. 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 Yongping Song (ph200811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety as assessed by the occurrence of study related adverse events. (time frame: 6 months). 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 29 Dec 2017.