Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (NCT04644016) | Clinical Trial Compass
RecruitingPhase 2
Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders
United States31 participantsStarted 2020-11-20
Plain-language summary
This is a single-arm study to investigate 1-year treatment related mortality (TRM) in patients with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic transplantation.
Who can participate
Age range21 Years
SexALL
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Participant Inclusion Criteria:
Age and Donor Status:
Patients with age ⤠21 years at time of consent with no available and suitably matched related or unrelated donor in the required time period.
Diagnoses :
I. Acute myelogenous leukemia (AML) :
* Complete first remission (CR1) at high risk for relapse such as any of the following:
* Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPS).
* Therapy-related AML (t-AML).
* White cell count at presentation \> 100,000.
* Presence of extramedullary leukemia at diagnosis.
* Any unfavorable subtype by FAB or WHO classification.
* High-risk cytogenetics (e.g. those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) or high-risk molecular abnormalities.
* Requirement for 2 or more inductions to achieve CR1.
* Presence of Minimal Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods after induction.
* Any patient with newly diagnosed AML with intermediate risk cytogenetics who elects allograft with curative intent over consolidation chemotherapy.
* Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.
* Other high-risk features not defined above.
* Complete second remission (CR2).
* Primary refractory or relapsed AML with less than 10% blasts by bone marrow morphology. Patients with cytogenetic, flow cytometric, or molecular abnormalities in ⤠10% of cells are eligible.
II.ā¦
What they're measuring
1
Treatment related mortality at 1 year after myeloablative cord transplant