Study Summary
This trial is testing a new stem cell transplantation method for people with blood cancers. The new method uses a machine to remove certain cells from the donor stem cells, and it also removes a different type of cell from the patient before transplant. The trial will measure how well the transplant works and how long the patient survives without the cancer coming back.
- Myelodysplasia
- Lymphoma
- Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 1 year
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Alpha Beta Non-irradiation regimen
1 of 3
Alpha Beta Total Body Irradiation - TBI last
1 of 3
Alpha Beta Total Body Irradiation - total body irradiation (TBI) first
1 of 3
Experimental Treatment
140 Total Participants · 3 Treatment Groups
Primary Treatment: Alpha Beta T cell depletion · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age < 65 · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Leahy, Allison Barz, Yimei Li, Julie-An Talano, Caitlin W. Elgarten, Alix E. Seif, Yongping Wang, Bryon Johnson, et al.. 2022. “Unrelated Donor Α/β T Cell– and B Cell–depleted HSCT for the Treatment of Pediatric Acute Leukemia”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2021005492.
- Leahy, Allison Barz, Yimei Li, Julie-An Talano, Caitlin W. Elgarten, Alix E. Seif, Yongping Wang, Bryon Johnson, et al.. 2022. “Unrelated Donor Α/β T Cell– and B Cell–depleted HSCT for the Treatment of Pediatric Acute Leukemia”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2021005492.
- Leahy AB, Li Y, Talano JA, Elgarten CW, Seif AE, Wang Y, Johnson B, Monos DS, Kadauke S, Olson TS, Freedman J, Wray L, Grupp SA, Bunin N. Unrelated donor alpha/beta T cell- and B cell-depleted HSCT for the treatment of pediatric acute leukemia. Blood Adv. 2022 Feb 22;6(4):1175-1185. doi: 10.1182/bloodadvances.2021005492.
- Nancy Bunin 2014. "Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02323867.
Frequently Asked Questions
What deleterious effects may come from Alpha Beta T cell depletion?
"Alpha Beta T cell depletion has been shown to some degree of safety, so it was assigned a score of 2. The lack of data demonstrating efficacy precludes assigning the medication any higher rating at this stage in the trial process." - Anonymous Online Contributor
Are there any vacancies remaining for individuals to participate in this experiment?
"Indeed, clinicaltrials.gov has evidence that this medical trial is actively recruiting patients, having been posted for the public on October 1st 2014 and last modified on October 28th 2022. Enrollment criteria includes 140 participants from at least one location." - Anonymous Online Contributor
What is the scale of participation in this experiment?
"Affirmative, the information on clinicaltrials.gov confirms that this research is currently recruiting volunteers. It was initially published on October 1st 2014 and recently revised on October 28th 2022; 140 individuals must be enrolled from a solitary site." - Anonymous Online Contributor