B-cell Acute Lymphoblastic LeukemiaPhase 2NCT04534634
Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）
A Phase 2 study testing IFN-α combined with CAR-T cell therapy in people with B-cell Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL). Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- IFN-α combined with CAR-T cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Jul 2025
- Phase
- Phase 2
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
- Age 12-65.
- Eastern Cooperative Oncology Group (ECOG) score 0-2.
- Target on leukemia is >20% positive detected with flowcytometry.
- Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
- 5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
- 6.No other immunotherapy was received within 3 months.
Who cannot join
- Patients are pregnant or lactating.
- Patients with congenital immunodeficiency.
- Patients with central nervous system leukemia.
- Patients with uncontrolled active infection.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with HIV infection.
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- Patients with atrial or venous thrombosis or embolism.
- Patients with myo-infarction or severe arrythmia in the recent 6 months.
- Other comorbidities that investigators considered not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
xiaowen tang, doctor, 13913538266, xwtang1020@163.com
About this study
Official title: An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
Read the detailed description
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- IFN-α combined with CAR-T cell therapy
- Keywords
- IFN-α, CAR-T
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFN-α combined with CAR-T cell therapyCombination product
Also called CAR-T cell therapy
Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle.
Children: 14 daily intramuscular injections 200mg/m^2 of Interferon-α for a 28-day cycle.
CAR T cell: (1-2)×10^7/kg, intravenously infusion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | IFN-α combined with CAR T-cells therapy Receives: Combination Product: IFN-α combined with CAR-T cell therapy |
| Control group | No intervention | CAR T-cells therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Measured: 2 years
Secondary outcomes (5)
Overall survival (OS)
time from enrollment to the date of death from any cause
Measured: 2 years
Leukemia-free survival (LFS)
time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause
Measured: 2 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
Measured: 2 years
the duration of CAR-T cells in patients
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Measured: 2 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0
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 posted1 Sep 2020
- Study start1 Apr 2019
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2025 (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 The First Affiliated Hospital of Soochow UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowen Tang, The First Affiliated Hospital of Soochow University
- Investigators
- xiaowen tang, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534634
- Sponsor's protocol ID
- IFN-α+CAR-T
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)
- ClinicalTrials.gov ID
- NCT04534634
- Acronym / sponsor ID
- IFN-α+CAR-T
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Keywords
- IFN-α, CAR-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 1 Sep 2020 (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.
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
Detailed description
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: IFN-α combined with CAR-T cell therapyIFN-α combined with CAR T-cells therapy |
| Control group | No intervention | –CAR T-cells therapy |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
- Age 12-65.
- Eastern Cooperative Oncology Group (ECOG) score 0-2.
- Target on leukemia is >20% positive detected with flowcytometry.
- Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
Key exclusion criteria (9 listed)
- Patients are pregnant or lactating.
- Patients with congenital immunodeficiency.
- Patients with central nervous system leukemia.
- Patients with uncontrolled active infection.
- Patients with active hepatitis B or hepatitis C infection.
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 |
|---|---|---|
| IFN-α combined with CAR-T cell therapyAlso: CAR-T cell therapyAdults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle. Children: 14 daily intramuscular injections 200mg/m^2 of Interferon-α for a 28-day cycle. CAR T cell: (1-2)×10^7/kg, intravenously infusion. | Combination product | Experimental group |
Primary outcome
Overall response rate (ORR)
Time frame: 2 years
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
5 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Leukemia-free survival (LFS)
Time frame: 2 years
Cumulative incidence of relapse(CIR)
Time frame: 2 years
the duration of CAR-T cells in patients
Time frame: 2 years
Number of adverse events
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 1 Sep 2020.
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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.
xiaowen tang, Ph.D principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IFN-α combined with CAR-T cell therapy in people with B-cell Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University 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 7 inclusion and 9 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 1 Sep 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 xiaowen tang, Ph.D (1391353826, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 2 years). 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 1 Sep 2020.