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NCT02120157 · ClinicalTrials.gov registry record · Phase 2
Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT02120157 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 35 participants.
The verdict
NCT02120157, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a multi-institutional phase II haploidentical T cell replete bone marrow transplant (BMT) study in children with high-risk leukemia. The myeloablative conditioning regimen prescribed will be Total body irradiation (TBI)-based for lymphoid leukemia and busulfan-based for myeloid leukemia. Our goal is to establish an easily exportable, inexpensive platform for haplotransplantation that has a safety profile equivalent to matched related and unrelated BMTs. The primary objective will be to estimate the incidence of 6-month non-relapse mortality (NRM), hypothesizing that NRM is \< 18%.
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
- DRUG Tacrolimus
- RADIATION TBI
- OTHER Unmanipulated Bone Marrow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-07-02 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02120157
The ClinicalTrials.gov registry entry for NCT02120157 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02120157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02120157 about?
NCT02120157 is a clinical study titled "Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies". This is a multi-institutional phase II haploidentical T cell replete bone marrow transplant (BMT) study in children with high-risk leukemia. The myeloablative conditioning regimen prescribed will be Total body irradiation (TBI)-based for lymphoid leukemia and busulfan-based for myeloid leukemia. Our...
What is the current status of trial NCT02120157?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2015-07-02. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT02120157?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG), Tacrolimus (DRUG), TBI (RADIATION), Unmanipulated Bone Marrow (OTHER).
Who is sponsoring clinical trial NCT02120157?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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