Alpha Beta T cell depletion for Myelodysplasia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
The Children's Hospital of Philadelphia, Philadelphia, PAMyelodysplasia+2 MoreAlpha Beta T cell depletion - Device
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Myelodysplasia
  • Lymphoma
  • Leukemia

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days
Severe acute and chronic graft versus host disease (GVHD)

Trial Safety

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

Alpha Beta Non-irradiation regimen
Device
Experimental Group · 1 Intervention: Alpha Beta T cell depletion · Intervention Types: Device
Alpha Beta Total Body Irradiation - TBI last
Device
Experimental Group · 1 Intervention: Alpha Beta T cell depletion · Intervention Types: Device
Alpha Beta Total Body Irradiation - total body irradiation (TBI) first
Device
Experimental Group · 1 Intervention: Alpha Beta T cell depletion · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
661 Previous Clinical Trials
7,854,456 Total Patients Enrolled
Nancy J Bunin, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
3 Previous Clinical Trials
205 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 12 Total Inclusion Criteria

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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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.