CART TherapyNCT05390671
CAR-T Cell Therapy in Patients With Hematological Malignancies
An observational study of CART Therapy, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular at 1 site in Spain.
Trial summary
The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CART Therapy
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 1 Jun 2021
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients >18, with hematologic malignancies (lymphoma, leukemia, myeloma) in which the use of CAR-T therapy is approved, undergoing CAR-T therapy in Spain.
Who may be able to join
- Adult patients >18 y/o
- Patients receiving CAR-T cell therapy in Spain, since 2018.
Who cannot join
- Patients receiving CART therapy as part of a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain
The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.
Read the detailed description
Information on baseline patient characteristics, haematological disease, comorbidities and CAR-T therapy procedure (lymphodepletion schedule, infused product) will be collected. Early post-infusion toxicity and recurrence data will be collected. The grading of adverse effects will follow the EBMT and ASTCT guidelines. Finally, data will be collected to analyse survival and, in case of death, cause of death).
- Conditions
- CART Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Patients who relapse or progress at 6 month after CART infussion.
Measured: 6 month
Progression free survival
Patients who relapse or progress at 12 month after CART infussion.
Measured: 12 month
Progression free survival
Patients who relapse or progress at 24 month after CART infussion.
Measured: 24 month
Secondary outcomes (3)
Overall survival
Measured: 6 month,12 month and 24 month
High relevance toxicity rates
Rate of grade 3 or more of CRS and neurotoxicity
Measured: During the firs month
Progression free survival
Patients who relapse or progress at 6, 12, 24 months from apheresis
Measured: 6 month,12 month and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Nov 2020
- Primary completion1 Jan 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CART TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 260 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390671
- Sponsor's protocol ID
- GETH-CART-2020-01
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain
- ClinicalTrials.gov ID
- NCT05390671
- Acronym / sponsor ID
- GETH-CART-2020-01
- Conditions
- CART Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celularUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 25 May 2022 (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 prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.
Detailed description
Information on baseline patient characteristics, haematological disease, comorbidities and CAR-T therapy procedure (lymphodepletion schedule, infused product) will be collected. Early post-infusion toxicity and recurrence data will be collected. The grading of adverse effects will follow the EBMT and ASTCT guidelines. Finally, data will be collected to analyse survival and, in case of death, cause of death).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients >18, with hematologic malignancies (lymphoma, leukemia, myeloma) in which the use of CAR-T therapy is approved, undergoing CAR-T therapy in Spain.
Key inclusion criteria (2 listed)
- Adult patients >18 y/o
- Patients receiving CAR-T cell therapy in Spain, since 2018.
Key exclusion criteria (1 listed)
- Patients receiving CART therapy as part of a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival
Time frame: 6 month
Patients who relapse or progress at 6 month after CART infussion.
Progression free survival
Time frame: 12 month
Patients who relapse or progress at 12 month after CART infussion.
Progression free survival
Time frame: 24 month
Patients who relapse or progress at 24 month after CART infussion.
3 secondary outcomes
Overall survival
Time frame: 6 month,12 month and 24 month
High relevance toxicity rates
Time frame: During the firs month
Progression free survival
Time frame: 6 month,12 month and 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Related trials for CART Therapy
Active, not recruitingPhase 2
A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
Plasma Cell Leukemia
RecruitingPhase 2
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Multiple Myeloma, Refractory to Standard Treatment, Multiple Myeloma, Relapsed
Not yet recruitingPhase 1
Universal CAR-T Cells Targeting Multiple Myeloma
Multiple Myeloma in Remission
Not yet recruitingPhase 1/2
Multi-4SCAR-T Therapy Targeting Breast Cancer
Breast Cancer
Not yet recruitingPhase 1/2
4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
Neuroblastoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CART Therapy, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular at 1 site in Spain.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jun 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (time frame: 6 month). The study lists 3 primary outcomes in all. 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 Jun 2022.