Hematological MalignancyPhase 2CASPERNCT06066255
PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM
A Phase 2 study testing Thymoglobulin Injectable Product in people with Hematological Malignancy, run by Institut Paoli-Calmettes.
Trial summary
The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- Thymoglobulin Injectable Product
- Type of treatment
- Injection or infusion
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2024to 31 Mar 2026
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3),
- Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome,
- Patient having received an allograft within ≤ 35 days, performed with the following modalities:
- First allogeneic transplant,
- Haploidentical donor,
- Peripheral stem cell transplant,
Show all 11Show fewer
- Non-myeloablative "Baltimore"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation),
- Standard GVHD prophylaxis in the context of haploidentical transplants (post-transplant cyclophosphamide, ciclosporin A and mycophenolate mofetil).
- Patient discharged from aplasia within ≤ 35 days,
- Signed informed consent form,
- Affiliation with a social security.
Who cannot join
- Previous allogeneic or organ transplant,
- Presence of signs of GVHD,
- Contraindications to treatment with Thymoglobuline®,
- Hypersensitivity to rabbit proteins or to any of the excipients listed in the "Composition" section of the summary of product characteristics,
- Pregnant women or may become pregnant (without effective contraception) or breast-feeding,
- Persons in emergency situations or unable to give informed consent form,
- Adult with a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
- Unable to comply with medical follow-up for geographical, social or psychological reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: REINFORCED PROPHYLAXIS OF GVH IN ELDERLY PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES RECEIVING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: USE OF A LOW DOSE OF POST-ALLOGRAFT ANTI-LYMPHOCYTIC SERUM
The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation.
Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.
- Conditions
- Hematological Malignancy
- Being tested
- Thymoglobulin Injectable Product
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymoglobulin Injectable ProductDrug
single intravenous injection of thymoglobulin
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute GVH
To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
Measured: Day 100
Secondary outcomes (9)
Acute GVH
Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft
Measured: day(D) 30, D60, D90, D100, D120, D180, D270 and D365
chronic GVH
Chronic GVHD will be assessed using NIH classification post allograft,
Measured: day(D)100, D120, D180, D270 and D365
Cumulative incidence of chronic GVH
Cumulative incidence of chronic GVHD at 1 year post-transplant,
Measured: 1 year
Cumulative incidence of NRM
Cumulative incidence of NRM at 1 year post-transplant,
Measured: 1 year
Cumulative incidence of relapse
Cumulative incidence of relapse at 1 year post-transplant,
Measured: 1 year
Immunology
Blood T, B and NK lymphocyte counts post-transplant,
Measured: day(D)100, D120, D180, D270 and D365
Viral infections
Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,
Measured: between day (D)30 and D120
Cumulative incidence
Cumulative incidence of EBMT-defined "poor graft function" post-transplant.
Measured: Day 100
Survival
Progression-free survival and overall survival at 1 year post-transplant,
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start31 Mar 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066255
- Sponsor's protocol ID
- CASPER-ATG-IPC 2023-015
- Acronym
- CASPER
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REINFORCED PROPHYLAXIS OF GVH IN ELDERLY PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES RECEIVING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: USE OF A LOW DOSE OF POST-ALLOGRAFT ANTI-LYMPHOCYTIC SERUM
- ClinicalTrials.gov ID
- NCT06066255
- Acronym / sponsor ID
- CASPER / CASPER-ATG-IPC 2023-015
- Conditions
- Hematological Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 4 Oct 2023 (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 aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation.
Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3),
- Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome,
- Patient having received an allograft within ≤ 35 days, performed with the following modalities:
- Patient discharged from aplasia within ≤ 35 days,
- Signed informed consent form,
Key exclusion criteria (8 listed)
- Previous allogeneic or organ transplant,
- Presence of signs of GVHD,
- Contraindications to treatment with Thymoglobuline®,
- Hypersensitivity to rabbit proteins or to any of the excipients listed in the "Composition" section of the summary of product characteristics,
- Pregnant women or may become pregnant (without effective contraception) or breast-feeding,
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 |
|---|---|---|
| Thymoglobulin Injectable Productsingle intravenous injection of thymoglobulin | Drug | – |
Primary outcome
Rate of acute GVH
Time frame: Day 100
To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
9 secondary outcomes
Acute GVH
Time frame: day(D) 30, D60, D90, D100, D120, D180, D270 and D365
chronic GVH
Time frame: day(D)100, D120, D180, D270 and D365
Cumulative incidence of chronic GVH
Time frame: 1 year
Cumulative incidence of NRM
Time frame: 1 year
Cumulative incidence of relapse
Time frame: 1 year
Immunology
Time frame: day(D)100, D120, D180, D270 and D365
Viral infections
Time frame: between day (D)30 and D120
Cumulative incidence
Time frame: Day 100
Survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Hematological Malignancy
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymoglobulin Injectable Product in people with Hematological Malignancy, run by Institut Paoli-Calmettes.
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 8 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jihane PAKRADOUNI (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute GVH (time frame: Day 100). 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 20 Feb 2024.