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Cell Depletion

alpha beta depletion for Acute Leukemia

New York Medical College, Valhalla, NY
Targeting 9 different conditionsalpha beta depletionPhase 2RecruitingResearch Sponsored by Mitchell Cairo

Study Summary

This trial is testing a new stem cell selection method for children, adolescents, and young adults undergoing an AlloSCT. The new method uses α/β CD3+/CD19+ cell depletion to select the stem cells, and all other treatment is standard of care.

Eligible Conditions
  • Acute Leukemia
  • Beta Thalassemia
  • Severe Aplastic Anemia
  • Diamond-Blackfan Anemia
  • Kostmann Syndrome
  • Amegakaryocytic Thrombocytopenia
  • Sickle Cell Disease
  • Non-Hodgkin Lymphoma
  • Hodgkin's Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
Your organs are working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Secondary outcome measures
incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: alpha beta cell depletionExperimental Treatment1 Intervention
Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.

Find a site

Who is running the clinical trial?

Mitchell CairoLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Mitchell S CairoStudy Chair
New York Medical College
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Alpha/Beta Depletion (Cell Depletion) Clinical Trial Eligibility Overview. Trial Name: NCT04099966 — Phase 2
Acute Leukemia Research Study Groups: alpha beta cell depletion
Acute Leukemia Clinical Trial 2023: Alpha/Beta Depletion Highlights & Side Effects. Trial Name: NCT04099966 — Phase 2
Alpha/Beta Depletion (Cell Depletion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04099966 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the qualifications to be included in this medical experiment?

"This clinical trial is seeking participants with congenital hypoplastic anemia between the ages of one day and 30 years old. The total number of enrollees for this study will be 20 individuals."

Answered by AI

Could you elaborate on the potential risks of alpha beta depletion for those receiving treatment?

"Despite the fact that there is no evidence of efficacy, alpha beta depletion's safety was evaluated as a 2 due to limited clinical data demonstrating its security."

Answered by AI

Is this research endeavor actively seeking participants?

"Clinicaltrials.gov shows that this experiment is still searching for participants since its initial post on April 1st 2021 and subsequent revision dated September 27th 2022."

Answered by AI

How many research participants are taking part in this investigation?

"Affirmative. Clinicaltrials.gov displays that this medical trial, initially posted on April 1st 2021, is currently enrolling participants. There is a requirement for 20 individuals at one facility to join the study."

Answered by AI

Is the upper age limit of 55 applicable to participants in this scientific trial?

"This trial only considers patients between one day and thirty years of age. Additionally, there are 586 clinical trials that focus on minors and 1979 studies for senior citizens."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
Mitchell Cairo 2021. "AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04099966.
~2 spots leftby Dec 2023
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