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New treatment option for Biphenotypic Acute Leukemia
Official title Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis
ClinicalTrials.gov ID: NCT06756152
What this study is testing
What is Conditioning regimen: Treosulfan 42 g/m2/course or total body irradiation 12 Gray/course, Etoposide 60 mg/kg , Fludarabine 150?
Conditioning regimen: Treosulfan 42 g/m2/course or total body irradiation 12 Gray/course, Etoposide 60 mg/kg , Fludarabine 150 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for biphenotypic acute leukemia.
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
- GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and Ruxolitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
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 21
You may be able to join if
- 1\. Patients under the age of 21 years with following diseases:
- acute lymphoblastic,
- myeloblastic,
- biphenotypic,
- bilinear leukemia,
You likely can't join if
- Age over 21 years
- Patients with ALL outside clinical and hematological remission
- Clinical status:
- Lansky/Karnowski index \<70% (supplement No.1)
- Heart function: left ventricular ejection fraction \<40% according to ultrasound of the heart1
- Kidney function: clearance of endogenous creatinine \< 70 ml / min
See the full eligibility criteria
- 1\. Patients under the age of 21 years with following diseases:
- acute lymphoblastic,
- myeloblastic,
- biphenotypic,
- bilinear leukemia,
- malignant lymphoma,
- myelodysplastic syndrome,
- Age over 21 years
- Patients with ALL outside clinical and hematological remission
- Clinical status:
- Lansky/Karnowski index \<70% (supplement No.1)
- Heart function: left ventricular ejection fraction \<40% according to ultrasound of the heart1
- Kidney function: clearance of endogenous creatinine \< 70 ml / min
- Liver function: total bilirubin, ALT, AST, ALP \> 2 norms
- Lung function: lung capacity \<50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry \<92%
- Uncontrolled viral, fungal or bacterial infection.
- Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime 1 These patients may receive...
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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 21 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.