Lymphoma, Large B-Cell, DiffusePhase 2NCT02846584
a Clinical Research of Sequential CAR-T Bridging HSCT in the Treatment of Relapse/Refractory B-cell Malignancies
A Phase 2 study testing CD19 or CD20 CAR T cells briging HSCT in people with Lymphoma, Large B-Cell, Diffuse and Leukemia, Lymphocytic, Chronic, B-Cell, run by Southwest Hospital, China at 1 site in China.
Trial summary
The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma，Malignant
- What is being tested?
- CD19 or CD20 CAR T cells briging HSCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2019
- 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 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- CD19-expressing or CD20-expressing relapsed or refractory B cell malignancies after at least one standard chemotherapy and one salvage regimen.According to current traditional therapies, there must be no available alternative curative therapies.
- Patients enrolled must have an evaluated score above 60 with KPS.
- Expected survival time of patients enrolled is over 3 months.
- Gender is not limited, age from 14 years to 75 years.
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
- Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
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- Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy: CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of < 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation)
- Patients with isolated CNS relapse will be eligible if they have previously been treated with cranial radiation (at least 1800 cGy).
- Ability to give informed consent.
- Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
- Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
- Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
- Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Patients volunteer to participate in the research.
Who cannot join
- Subjects meeting any of the following criteria are not eligible for participation in the study:
- Patients are evaluated below 50 scores with KPS.
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
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- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females. HIV infection.
- Active hepatitis B or active hepatitis C.
- Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- Other situations we think not eligible for participation in the research.
Trial locations and contacts
1 site in 1 country.
China1 site
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000
About this study
Official title: a Clinical Research of Sequential CAR-T Bridging Hematopoietic Stem Cell Transplantation in the Treatment of Relapse/Refractory B-cell Malignancies
The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies.
Read the detailed description
The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. Recently the anti-CD20 CAR T cells has been used in the treatment of relapsed/refractory DLBCL and exhibited good clinical outcomes.
However, patients treated with CAR-T may face relapse of CD19 or CD20 mutation. Therefore we attempt to maintain and relieve patients by sequential therapy of the HSCT and hope to combine their advantages.
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma，Malignant
- Being tested
- CD19 or CD20 CAR T cells briging HSCT
- Keywords
- CAR T, HSCT
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 or CD20 CAR T cells briging HSCTBiological
Patients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells.
| Study group | Role | What they receive |
|---|---|---|
| CD19 or CD20 CAR T cells briging HSCT | Experimental | lentiviral transfection and transfuse anti-CD19 or anti-CD20 CAR T cells into patients. Six months later, select appropriate patients to transplant hemopoietic stem cells. Receives: Biological: CD19 or CD20 CAR T cells briging HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate of patients treated with anti-CD19 or anti-CD20 CAR T cells
Measured: 2 years
Secondary outcomes (2)
Treatment response rate of anti-CD19 CAR T cell infusion
Measured: 4 weeks
Number of patients with adverse events
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 posted27 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 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 Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieping Chen, Southwest Hospital, China
- Investigators
- Jieping Chen, MD,PhD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846584
- Sponsor's protocol ID
- Southwest Hospital，China
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Clinical Research of Sequential CAR-T Bridging Hematopoietic Stem Cell Transplantation in the Treatment of Relapse/Refractory B-cell Malignancies
- ClinicalTrials.gov ID
- NCT02846584
- Acronym / sponsor ID
- Southwest Hospital，China
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma，Malignant
- Keywords
- CAR T, HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Jul 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.
The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies.
Detailed description
The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. Recently the anti-CD20 CAR T cells has been used in the treatment of relapsed/refractory DLBCL and exhibited good clinical outcomes.
However, patients treated with CAR-T may face relapse of CD19 or CD20 mutation. Therefore we attempt to maintain and relieve patients by sequential therapy of the HSCT and hope to combine their advantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 or CD20 CAR T cells briging HSCT | Experimental | Biological: CD19 or CD20 CAR T cells briging HSCTlentiviral transfection and transfuse anti-CD19 or anti-CD20 CAR T cells into patients. Six months later, select appropriate patients to transplant hemopoietic stem cells. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- CD19-expressing or CD20-expressing relapsed or refractory B cell malignancies after at least one standard chemotherapy and one salvage regimen.According to current traditional therapies, there must be no available alternative curative therapies.
- Patients enrolled must have an evaluated score above 60 with KPS.
- Expected survival time of patients enrolled is over 3 months.
- Gender is not limited, age from 14 years to 75 years.
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
Key exclusion criteria (13 listed)
- Subjects meeting any of the following criteria are not eligible for participation in the study:
- Patients are evaluated below 50 scores with KPS.
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
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 |
|---|---|---|
| CD19 or CD20 CAR T cells briging HSCTPatients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells. | Biological | CD19 or CD20 CAR T cells briging HSCT |
Primary outcome
Overall survival rate of patients treated with anti-CD19 or anti-CD20 CAR T cells
Time frame: 2 years
2 secondary outcomes
Treatment response rate of anti-CD19 CAR T cell infusion
Time frame: 4 weeks
Number of patients with 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 7 Sep 2016.
- 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.
Jieping Chen, MD,PhD principal investigator
Southwest Hospital, China
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 CD19 or CD20 CAR T cells briging HSCT in people with Lymphoma, Large B-Cell, Diffuse and Leukemia, Lymphocytic, Chronic, B-Cell, run by Southwest Hospital, China 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 14 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 Sep 2016. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate of patients treated with anti-CD19 or anti-CD20 CAR T cells (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 7 Sep 2016.