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CASPER-ATG-IPC 2023-015 : Reinforced prophylaxis of GVH in elderly patients with haematological malignancies receiving haploidentical allogenic hematopoietic stem cell transplantation: use of a low dose of post-allograft anti-lymphocytic serum.
EU CTIS ID: 2023-506648-18-00
What this study is testing
To assess efficacy of enhanced GVH prophylaxis with low-dose ATG administered at the time of neutrophil recovery after haplo-identical allogeneic transplantation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- adult with age ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3)
- haematological malignancies except for myeloproliferative syndrome and myelodysplastic syndrome
- Patient having received an allograft within ≤ 35 days, performed with the following modalities: o First allogeneic transplant, o Haploidentical donor, o Peripheral stem cell transplant, o Non-myeloablative "Baltimore"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation), o Standard GVH 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
You likely can't join if
- previous allogeneic transplant or organ transplant
- presence of GVH
- contraindication 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
- Person in an emergency situation or unable to give informed consent form
See the full eligibility criteria
- adult with age ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3)
- haematological malignancies except for myeloproliferative syndrome and myelodysplastic syndrome
- Patient having received an allograft within ≤ 35 days, performed with the following modalities: o First allogeneic transplant, o Haploidentical donor, o Peripheral stem cell transplant, o Non-myeloablative "Baltimore"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation), o Standard GVH 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
- previous allogeneic transplant or organ transplant
- presence of GVH
- contraindication 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
- Person in an emergency situation 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.