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NCT03779854 · ClinicalTrials.gov registry record · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
A Phase 2 study of Acute Lymphoblastic Leukemia and Acute Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 10
- Study locations
NCT03779854: Recruiting Phase 2 study of Acute Lymphoblastic Leukemia and Acute Leukemia, sponsored by Fred Hutchinson Cancer Center.
NCT03779854 is a Phase 2 study of Acute Lymphoblastic Leukemia and Acute Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 68 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (82% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03779854, a Phase 2 study of Acute Lymphoblastic Leukemia and Acute Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.
Primary Outcome
Success defined as achievement of cell selection goals for two consecutive Naive T cells (TN)-depleted peripheral blood stem cells (PBSC) hematopoietic cell transplantation (HCTs) at each study site (Feasibility)
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- RADIATION Total-Body Irradiation
- DRUG Thiotepa
Study Locations (10)
Ohio
- UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center) - Cleveland
- Cleveland Clinic Foundation - Cleveland
California
- Children's Hospital of Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Atlanta
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Massachusetts
- Dana Farber / Boston Children's Hospital - Boston
Oregon
- Oregon Health and Science University - Portland
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT03779854 shows while recruiting
NCT03779854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (82% lower).
The record links to 10 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03779854 lists 10 locations in 9 states (Ohio, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT03779854 about?
NCT03779854 is a clinical study titled "Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant". This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called ...
What is the current status of trial NCT03779854?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2019-08-29. Estimated completion is 2027-12-31.
What conditions does trial NCT03779854 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Biphenotypic Leukemia, Acute Leukemia of Ambiguous Lineage.
What interventions are being tested in trial NCT03779854?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total-Body Irradiation (RADIATION), Thiotepa (DRUG).
Who is sponsoring clinical trial NCT03779854?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03779854 being conducted?
This trial has 10 study locations across California, District of Columbia, Georgia, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03779854's enrollment target sits among peer trials
68 61st of 131 higher than 71 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
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MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
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Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
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