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NCT00013533 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies
A Early Phase 1 study of Lymphoma and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00013533 is a Early Phase 1 study of Lymphoma and Myelodysplastic Syndrome that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00013533, a Early Phase 1 study of Lymphoma and Myelodysplastic Syndrome, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies. Unfortunately, the success of conventional allogeneic BMT is limited in part by the multiple toxicities associated with myeloablative preparative regimens. * Non-myeloablative pre-transplant regimens are associated with less toxic side effects than standard BMT. Recently, a novel immunosuppressive, non-myeloablative pre-transplant chemotherapy regimen has been shown to facilitate complete donor engraftment in an adult trial at the NCI. Objectives: The primary objective of this protocol is to evaluate the efficacy and safety of this treatment approach in pediatric patients with hematopoietic malignancies Eligibility: Inclusion Criteria Age: Patient must be greater than or equal to 5 years and less than 22 years of age. Diagnosis: * Hodgkin s and Non-Hodgkin s Lymphoma: Refractory disease or relapse after salvage regimen. * Acute Myelogenous Leukemia: History of bone marrow relapse in remission (CR) #2 or greater. * Acute Lymphocytic Leukemia: History of bone marrow relapse in CR #2 or greater (CR#1 with Philadelphia chromosome positive or prior induction failure). * Acute Hybrid Leukemia including mixed lineage, biphenotypic and undifferentiated: History of bone marrow relapse in CR #2 or greater (CR#1 with Philadelphia chromosome positive or prior induction failure). * Myelodysplastic Syndrome: RAEB or RAEB-t with less than 10% blasts in marrow and blood. * Chronic Myelogenous Leukemia: Chronic phase or accelerated phase with less than 10% blasts in marrow and blood. * Juvenile Myelomonocytic Leukemia: less than 10% blasts in marrow and blood. Prior Therapy: Chemotherapy to achieve above criteria allowed. Prior BMT allowed as long as at least day 100+ post-prior BMT, no evidence of GVHD, and no detectable residual donor chimerism. Donor: First degree related donors, who are HLA matched (single HL
Conditions Studied
Interventions
- PROCEDURE Stem cell transplantation
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-03-14 |
| Est. Completion | 2015-05-07 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00013533
The ClinicalTrials.gov registry entry for NCT00013533 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Stem cell transplantation is the first listed.
NCT00013533 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00013533 about?
NCT00013533 is a clinical study titled "Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies". Background: * Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies. Unfortunately, the success of conventional allogeneic BMT is limited in part by the multiple toxicities associated with myeloablative pr...
What is the current status of trial NCT00013533?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2001-03-14. Estimated completion is 2015-05-07.
What conditions does trial NCT00013533 study?
This clinical trial studies the following conditions: Lymphoma, Myelodysplastic Syndrome, Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, AML.
What interventions are being tested in trial NCT00013533?
The interventions under investigation include: Stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00013533?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00013533 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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