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New treatment option for Hematologic Malignancy
Official title Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
ClinicalTrials.gov ID: NCT05066412
What this study is testing
- What it's testing
- To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- Written informed consent of patient and donor obtained
You likely can't join if
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Mycophenolate Mofetil
- Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
- Progressive hematologic malignancy before transplant
- Second allogeneic transplant
See the full eligibility criteria
- Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- Written informed consent of patient and donor obtained
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Mycophenolate Mofetil
- Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
- Progressive hematologic malignancy before transplant
- Second allogeneic transplant
- Acute GvHD ≥ grade 2
- Chronic moderate or severe GvHD (NIH consensus criteria)
- Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
- Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
- Participation in another treatment clinical trial within 30 days prior to inclusion
- Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from...
- Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.