Diffuse Large B Cell LymphomaPhase 2NCT06589089
Autologous Hematopoietic Stem Cell Boost Study After CAR-T Therapy
A Phase 2 study testing autologous hematopoietic stem cell in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- autologous hematopoietic stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older and gender-neutral;
- Diagnosis of B-cell non-Hodgkin lymphoma confirmed histologically or cytologically according to World Health Organization 2016 criteria;
- Prior CAR-T cell immunotherapy;
- Patients who are at high risk according to the CAR-HEMATOTOX score prior to leukapheresis; or patients who are clinically considered potentially at high risk for hematologic toxicity following immunotherapy (including age ≥60 years; or Eastern Cooperative Oncology Group (ECOG) Performance Status≥ 2 points; or number of prior lines of therapy ≥ 2, etc.);
- Myelosuppression as determined by the investigator has occurred after CAR-T therapy;
- Have a storage of stem cell;
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- Stable lymphoma disease status (final investigator-assessed efficacy CR/PR);
- Bone marrow biopsy to rule out hemophilia/infection/bone marrow infiltration;
- Adequate organ function;
- Able to provide written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule;
- Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study, and for 120 days after the last dose of treatment.
Who cannot join
- History of allogeneic hematopoietic stem cell transplantation;
- History of epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
- Presence of or current concurrent other malignancies within the past 2 years, with the exception of cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers, and superficial bladder tumors (Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane));
- Suffering from severe cardiovascular disease: grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) <50%;
- Allergy to any investigational drug or excipient;
- Presence of any active autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allograft transplantation, or patients with prolonged and heavy use of hormones or use of other immune-modulating agents or other patients who, as assessed by the Investigator Patients who are considered to have an impact on study treatment;
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- Have an active infection;
- History of uncontrolled systemic disease, including diabetes mellitus, hypertension, and acute pulmonary disease;
- Known human immunodeficiency virus (HIV) infection;
- Presence of an underlying medical condition or alcohol/substance abuse or dependence that is not conducive to the administration of study medication, or that may interfere with the interpretation of results, or that puts the patient at high risk for developing treatment complications;
- End-organ damage due to autoimmune disease (e.g., Crohns disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years, or the need for systemic immunosuppression or other systemic disease-control medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Weili Zhao, zwl_trial@163.com
About this study
Official title: Prospective Study of Autologous Hematopoietic Stem Cell Boost to Improve Myelosuppression in B-NHL Patients with High-risk Immunologic Hematologic Toxic After Chimeric Antigen Receptor T-Cell Immunotherapy
This is a prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy Therapy) . After the patient has completed CAR-T therapy, if the patient has unrelieved hematologic toxicity, consider infusing a reserve of stem cells; if myelosuppression has not been significantly relieved, stem cell infusion can be performed again.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- autologous hematopoietic stem cell
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous hematopoietic stem cellDrug
Intervention were given myelosuppression occurring that cannot be controlled with other drugs as judged by the investigators
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with stem cell boost | Experimental | If the patient continues to have unrelieved hematologic toxicity after CAR-T cell therapy, consider infusing a reserve of stem cells; If there is no significant recovery from myelosuppression, another stem cell infusion can be performed. Receives: Drug: autologous hematopoietic stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year overall survival
Overall survival was defined as the time from the date of leukapheresis to the date of death from any cause.
Measured: 1 year after CAR-T cell infusion
Secondary outcomes (8)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: End of treatment visit (1 years after stem cell infusion)
Best objective response rate
Defined as the proportion of patients with an efficacy evaluation of complete response (CR) or partial response (PR) at any time point after infusing back CAR-T cells as a percentage of all patients, with efficacy assessed by the investigators according to the 2014 Lugano efficacy criteria
Measured: End of treatment visit (1 years after stem cell infusion)
Best complete response rate
Defined as the proportion of patients with an efficacy evaluation of CR at any time point after infusing back CAR-T cells as a percentage of all patients, with efficacy assessed by the investigators according to the 2014 Lugano efficacy criteria
Measured: End of treatment visit (1 years after stem cell infusion)
Time to reponse
Time from CAR-T cell infusion to the first assessment of CR or PR on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of treatment visit (1 years after stem cell infusion)
Duration of response
Time from the first efficacy assessment of CR or PR to the time of first disease progression on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of treatment visit (1 years after stem cell infusion)
Progression-free survival
Progression-free survival was defined as the time from the date of leukapheresis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: End of treatment visit (1 years after stem cell infusion)
Overall survival
Overall survival was defined as the time from the date of leukapheresis to the date of death from any cause.
Measured: End of treatment visit (1 years after stem cell infusion)
Overall days of hospitalization
Defined as total number of days admitted to the hospital since being infused back for CAR-T, including days of readmission for supportive care for myelosuppression
Measured: End of treatment visit (1 years after stem cell infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589089
- Sponsor's protocol ID
- CART-SCB
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2024
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Autologous Hematopoietic Stem Cell Boost to Improve Myelosuppression in B-NHL Patients with High-risk Immunologic Hematologic Toxic After Chimeric Antigen Receptor T-Cell Immunotherapy
- ClinicalTrials.gov ID
- NCT06589089
- Acronym / sponsor ID
- CART-SCB
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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 prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy Therapy) . After the patient has completed CAR-T therapy, if the patient has unrelieved hematologic toxicity, consider infusing a reserve of stem cells; if myelosuppression has not been significantly relieved, stem cell infusion can be performed again.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with stem cell boost | Experimental | Drug: autologous hematopoietic stem cellIf the patient continues to have unrelieved hematologic toxicity after CAR-T cell therapy, consider infusing a reserve of stem cells; If there is no significant recovery from myelosuppression, another stem cell infusion can be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older and gender-neutral;
- Diagnosis of B-cell non-Hodgkin lymphoma confirmed histologically or cytologically according to World Health Organization 2016 criteria;
- Prior CAR-T cell immunotherapy;
- Patients who are at high risk according to the CAR-HEMATOTOX score prior to leukapheresis; or patients who are clinically considered potentially at high risk for hematologic toxicity following immunotherapy (including age ≥60 years; or Eastern Cooperative Oncology Group (ECOG) Performance Status≥ 2 points; or number of prior lines of therapy ≥ 2, etc.);
- Myelosuppression as determined by the investigator has occurred after CAR-T therapy;
Key exclusion criteria (11 listed)
- History of allogeneic hematopoietic stem cell transplantation;
- History of epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
- Presence of or current concurrent other malignancies within the past 2 years, with the exception of cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers, and superficial bladder tumors (Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane));
- Suffering from severe cardiovascular disease: grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) <50%;
- Allergy to any investigational drug or excipient;
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 |
|---|---|---|
| autologous hematopoietic stem cellIntervention were given myelosuppression occurring that cannot be controlled with other drugs as judged by the investigators | Drug | Patients treated with stem cell boost |
Primary outcome
1-year overall survival
Time frame: 1 year after CAR-T cell infusion
Overall survival was defined as the time from the date of leukapheresis to the date of death from any cause.
8 secondary outcomes
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: End of treatment visit (1 years after stem cell infusion)
Best objective response rate
Time frame: End of treatment visit (1 years after stem cell infusion)
Best complete response rate
Time frame: End of treatment visit (1 years after stem cell infusion)
Time to reponse
Time frame: End of treatment visit (1 years after stem cell infusion)
Duration of response
Time frame: End of treatment visit (1 years after stem cell infusion)
Progression-free survival
Time frame: End of treatment visit (1 years after stem cell infusion)
Overall survival
Time frame: End of treatment visit (1 years after stem cell infusion)
Overall days of hospitalization
Time frame: End of treatment visit (1 years after stem cell infusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
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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.
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 autologous hematopoietic stem cell in people with Diffuse Large B Cell Lymphoma, run by Ruijin 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, Doctor (+862164370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year overall survival (time frame: 1 year after CAR-T cell infusion). 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 23 Oct 2024.