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Compares treatment options for Acute Myeloid Leukemia, Relapsed
Official title Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies
ClinicalTrials.gov ID: NCT07366801
What this study is testing
What is Cyclosporine A (CsA)?
Cyclosporine A (CsA) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia, relapsed.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Two key methods of GVHD prevention in allogeneic HSCT have a number of limitations: ex vivo T depletion is associated with an excess of infectious complications, and pharmacological immunosuppression with insufficient efficacy of GVHD prevention. Modern graft engineering technologies make it possible to create a graft with a balanced cell composition, reducing the risk of adverse events, in particular, severe forms of acute and chronic GVHD, while preserving the immunological function of the graft.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years).
- The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory...
- Planned HSCT from a haploidentical donor
- The Karnofsky or Lansky score is more than 70%
- Life expectancy of at least 8 weeks
You likely can't join if
- Acute viral hepatitis or acute HIV infection
- Hypoxemia with SaO2 \<90%
- Bilirubin \>3 normal
- Creatinine \>3 norms
- Pregnancy and lactation
- Life-threatening infection
See the full eligibility criteria
- Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years).
- The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework
- Planned HSCT from a haploidentical donor
- The Karnofsky or Lansky score is more than 70%
- Life expectancy of at least 8 weeks
- Heart function: ejection fraction of at least 40%
- Consent to continue follow-up for 3 years
- Acute viral hepatitis or acute HIV infection
- Hypoxemia with SaO2 \<90%
- Bilirubin \>3 normal
- Creatinine \>3 norms
- Pregnancy and lactation
- Life-threatening infection
- Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system)
- Karnofsky score or Lansky score \<70%
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
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, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. 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.