Hematological MalignancyNCT04287309
CAR-T Cellular Therapy for B Cell Malignancies Involved in CNS
An observational study of Hematological Malignancy, run by Zhejiang University at 2 sites in China.
Trial summary
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- CAR-T cells
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 28 Feb 2020to 28 Feb 2023
- Phase
- Observational
- 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 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CNS involvement
Who may be able to join
- 1.Male or female aged ≥ 3 and <70 years old; 2.Histologically confirmed diagnosis of CD19+ B cell malignancies involved in CNS 3.Relapsed or refractory CD19+ B cell malignancies 4.total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L; 5.Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 6.No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%; 7.Estimated survival time ≥ 3 months; 8.ECOG performance status 0 to 2; 8.Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Who cannot join
- Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
- extensive involvement of gastrointestinal lymphoma;
- radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
- Have a history of allergy to any of the components in the cell products;
- According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
- Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
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- Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).
- Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;
- History of other primary cancer, except for the following conditions:
- Cured non-melanoma after resection, such as basal cell carcinoma of the skin;
- Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;
- Patients with graft-versus-host disease (GVHD);
- 19.Prior immunizations with live vaccine 4 weeks prior to screening; 13.History of alcoholism, drug abuse or mental illness; 14.Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids; 15.Patients who have participated in any other clinical studies within 2 weeks prior to screening; 16.pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender); 17.Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, 310000
He Huang, PhD, 86-13605714822, huanghe@zju.edu.cn
- Recruiting
the First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Yongxian Hu, Dr, 15957162012, huyongxian2000@aliyun.com
About this study
Official title: CAR-T Cellular Therapy for B Cell Malignancies Involved in Central Nervous System
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy.
Read the detailed description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled. Primary objective is to explore the safety including the complication of cytokine release syndrome, CRES, pancytopenia and infection. The secondary objective is to explore the efficacy. We will also detect CAR-T cell expansion dynamics in blood and cerebral fluid and compare the difference.
- Conditions
- Hematological Malignancy
- Being tested
- CAR-T cells
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellsOther
CD19 targeted CAR-T treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 2 years
Secondary outcomes (1)
The response rate of CAR-T treatment in patients with relapse/refractory B cell malignancies involved in CNS that treated by CD19 CAR-T cells therapy
The response rate of BCMA CAR-T treatment will be recorded and assessed according to WHO criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start28 Feb 2020 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287309
- Sponsor's protocol ID
- 19-002
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2020
- Last updated
- 27 Feb 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 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Cellular Therapy for B Cell Malignancies Involved in Central Nervous System
- ClinicalTrials.gov ID
- NCT04287309
- Acronym / sponsor ID
- 19-002
- Conditions
- Hematological Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 27 Feb 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.
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy.
Detailed description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled. Primary objective is to explore the safety including the complication of cytokine release syndrome, CRES, pancytopenia and infection. The secondary objective is to explore the efficacy. We will also detect CAR-T cell expansion dynamics in blood and cerebral fluid and compare the difference.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CNS involvement
Key inclusion criteria (1 listed)
- 1.Male or female aged ≥ 3 and <70 years old; 2.Histologically confirmed diagnosis of CD19+ B cell malignancies involved in CNS 3.Relapsed or refractory CD19+ B cell malignancies 4.total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L; 5.Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 6.No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%; 7.Estimated survival time ≥ 3 months; 8.ECOG performance status 0 to 2; 8.Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Key exclusion criteria (15 listed)
- Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
- extensive involvement of gastrointestinal lymphoma;
- radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
- Have a history of allergy to any of the components in the cell products;
- According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
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 |
|---|---|---|
| CAR-T cellsCD19 targeted CAR-T treatment | Other | – |
Primary outcome
Adverse events that related to treatment
Time frame: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
1 secondary outcome
The response rate of CAR-T treatment in patients with relapse/refractory B cell malignancies involved in CNS that treated by CD19 CAR-T cells therapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancy, run by Zhejiang University at 2 sites 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 1 inclusion and 15 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 He Huang, PhD (13605714822, huanghe@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events that related to treatment (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 27 Feb 2020.