Malignant HemopathyAutoREANCT06894381
Characteristics and Results of Patients Treated by Therapeutic Intensification
An observational study of Malignant Hemopathy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Many studies have focused on patients treated with allogeneic peripheral stem cell transplantation; few studies have until now been carried out to describe the characteristics and results of autografted patients and to attempt to determine possible prognostic factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hemopathy
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2024to 20 Dec 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient (≥18 years old) admitted to the Intensive Care Unit within thirty days following therapeutic intensification and autograft of peripheral stem cells for the treatment of a hematologic malignancy
Who may be able to join
- Adult patient (≥18 years old)
- Gender indifferent
- Admitted to the Intensive Care Unit within thirty days following therapeutic intensification and autograft of peripheral stem cells for the treatment of a hematologic malignancy between 01/01/2013 and 12/31/2022
Who cannot join
- Subject having expressed his opposition to the reuse of his data for scientific research purposes
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Vincent CASTELAIN, MD, PhD, 33.3.88.12.79.15, vincent.castelain@chru-strasbourg.fr
Vincent CASTELAIN, MD, PhD
About this study
Official title: Characteristics and Results of Patients Treated by Therapeutic Intensification Followed by Autograft of Peripheral Stem Cells and Admitted to Intensive Care and Intensive Care: Single-center Retrospective Analysis
Many studies have focused on patients treated with allogeneic peripheral stem cell transplantation; few studies have until now been carried out to describe the characteristics and results of autografted patients and to attempt to determine possible prognostic factors. However, it is estimated that nearly 5% of autograft patients require MIR care. The investigators therefore wish to conduct a retrospective study including patients treated by therapeutic intensification followed by autograft of hematopoietic stem cells and admitted to the MIR department of the Hautepierre hospital of the University Hospitals of Strasbourg (HUS) within thirty days following initiation of chemotherapy.
- Conditions
- Malignant Hemopathy
- Keywords
- Malignant hemopathy, allogeneic, stem cell, transplantation, chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the clinical and biological characteristics of patients having therapeutic intensification and autograft of peripheral stem cells for the treatment of hematological malignancy
Measured: Thirty days following therapeutic intensification and autograft of peripheral stem cells in treatment of a malignant hematological disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start20 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HemopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894381
- Sponsor's protocol ID
- 9061
- Acronym
- AutoREA
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Results of Patients Treated by Therapeutic Intensification Followed by Autograft of Peripheral Stem Cells and Admitted to Intensive Care and Intensive Care: Single-center Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06894381
- Acronym / sponsor ID
- AutoREA / 9061
- Conditions
- Malignant Hemopathy
- Keywords
- Malignant hemopathy, allogeneic, stem cell, transplantation, chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 25 Mar 2025 (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.
Many studies have focused on patients treated with allogeneic peripheral stem cell transplantation; few studies have until now been carried out to describe the characteristics and results of autografted patients and to attempt to determine possible prognostic factors. However, it is estimated that nearly 5% of autograft patients require MIR care. The investigators therefore wish to conduct a retrospective study including patients treated by therapeutic intensification followed by autograft of hematopoietic stem cells and admitted to the MIR department of the Hautepierre hospital of the University Hospitals of Strasbourg (HUS) within thirty days following initiation of chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) admitted to the Intensive Care Unit within thirty days following therapeutic intensification and autograft of peripheral stem cells for the treatment of a hematologic malignancy
Key inclusion criteria (3 listed)
- Adult patient (≥18 years old)
- Gender indifferent
- Admitted to the Intensive Care Unit within thirty days following therapeutic intensification and autograft of peripheral stem cells for the treatment of a hematologic malignancy between 01/01/2013 and 12/31/2022
Key exclusion criteria (1 listed)
- Subject having expressed his opposition to the reuse of his data for scientific research purposes
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
Retrospective description of the clinical and biological characteristics of patients having therapeutic intensification and autograft of peripheral stem cells for the treatment of hematological malignancy
Time frame: Thirty days following therapeutic intensification and autograft of peripheral stem cells in treatment of a malignant hematological disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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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.
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 Malignant Hemopathy, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2025. 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 France. 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 Vincent CASTELAIN, MD, PhD (33.3.88.12.79.15, vincent.castelain@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the clinical and biological characteristics of patients having therapeutic intensification and autograft of peripheral stem cells for the treatment of hematological malignancy (time frame: Thirty days following therapeutic intensification and autograft of peripheral stem cells in treatment of a malignant hematological disease.). 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 25 Mar 2025.