Acute Lymphoblastic Leukemia ALLPhase 2NCT06608342
Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
A Phase 2 study testing Autologous hematopoietic stem cell transplantation combined with CD19-CART in people with Acute Lymphoblastic Leukemia ALL, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia ALL
- What is being tested?
- Autologous hematopoietic stem cell transplantation combined with CD19-CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 30 May 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with high-risk acute B-lymphoblastic leukemia
- Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared
- Eligible for autologous hematopoietic stem cell transplantation
- No major organ dysfunction
Who cannot join
- Combined with malignant tumors of other organs
- With a serious infection that is not under control
- Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive
- Patients who have had an allergic reaction to the drugs used in this study or similar drugs
- Other patients deemed unsuitable for inclusion by the investigators
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
NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
Tianjin, Tianjin Municipality, 300000
erlie EL Jiang, Doctor, +86-15122538106 ext. 022-23608602, jiangerlie@ihcams.ac.cn
rongli RL zhang, +86-13194633608 ext. 022-23608602
About this study
Official title: Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
Read the detailed description
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Being tested
- Autologous hematopoietic stem cell transplantation combined with CD19-CART
- Keywords
- inaticabtagene autoleucel, auto-HSCT
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hematopoietic stem cell transplantation combined with CD19-CARTBiological
Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Autologous hematopoietic stem cell transplantation combined with CD19-CART | Experimental | Not described Receives: Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate within 2 years
Measured: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Secondary outcomes (4)
Non-relapse mortality
Measured: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Progression-free survival
Measured: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Overall survival rate
Measured: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Incidence of infection
Measured: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start25 Jun 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia ALLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608342
- Sponsor's protocol ID
- IIT2024036
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Haven\'t thought it through yet
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06608342
- Acronym / sponsor ID
- IIT2024036
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Keywords
- inaticabtagene autoleucel, auto-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 23 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.
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
Detailed description
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous hematopoietic stem cell transplantation combined with CD19-CART | Experimental | Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with high-risk acute B-lymphoblastic leukemia
- Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared
- Eligible for autologous hematopoietic stem cell transplantation
- No major organ dysfunction
Key exclusion criteria (5 listed)
- Combined with malignant tumors of other organs
- With a serious infection that is not under control
- Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive
- Patients who have had an allergic reaction to the drugs used in this study or similar drugs
- Other patients deemed unsuitable for inclusion by the investigators
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 cell transplantation combined with CD19-CARTAutologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation | Biological | Autologous hematopoietic stem cell transplantation combined with CD19-CART |
Primary outcome
Relapse rate within 2 years
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
4 secondary outcomes
Non-relapse mortality
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Progression-free survival
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Overall survival rate
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Incidence of infection
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
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 Sep 2024.
- Individual participant dataSharing planned: Undecided. Haven\'t thought it through yet
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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 transplantation combined with CD19-CART in people with Acute Lymphoblastic Leukemia ALL, run by Institute of Hematology & Blood Diseases 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 4 inclusion and 5 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 Sep 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 erlie EL Jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate within 2 years (time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation). 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 Sep 2024.