Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00450450 · ClinicalTrials.gov registry record · Phase 3
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
A Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
- 20
- Study locations
NCT00450450: Completed Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
NCT00450450 is a Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 27 participants, below the 136-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450450, a Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.
Primary Outcome
EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL filgrastim
- PROCEDURE allogeneic bone marrow transplantation
Study Locations (20)
California
- Children's Oncology Group - Arcadia
- University of California San Francisco Medical Center-Parnassus - San Francisco
Indiana
- Indiana University Medical Center - Indianapolis
- Riley Hospital for Children - Indianapolis
Missouri
- The Childrens Mercy Hospital - Kansas City
- Washington University School of Medicine - St Louis
New York
- Roswell Park Cancer Institute - Buffalo
- New York Medical College - Valhalla
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Childrens Memorial Hospital - Chicago
Kentucky
- Kosair Children's Hospital - Louisville
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-12-31 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 3 |
What the finished NCT00450450 record still lists
NCT00450450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 136-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Juvenile Myelomonocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00450450 names 20 study sites across 16 states, led by California, Indiana, Missouri.
Frequently Asked Questions
What is clinical trial NCT00450450 about?
NCT00450450 is a clinical study titled "Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases". This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growt...
What is the current status of trial NCT00450450?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2007-12-31. Estimated completion is 2022-03-31.
What conditions does trial NCT00450450 study?
This clinical trial studies the following conditions: Juvenile Myelomonocytic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, de Novo Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission.
What interventions are being tested in trial NCT00450450?
The interventions under investigation include: laboratory biomarker analysis (OTHER), filgrastim (BIOLOGICAL), allogeneic bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00450450?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00450450 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Juvenile Myelomonocytic 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 NCT00450450's enrollment target sits among peer trials
27 8th of 11 higher than 4 of 11 other Juvenile Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Juvenile Myelomonocytic 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
-
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
COMPLETED · Phase 3
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
-
Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
RECRUITING · Phase 2
-
A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation
RECRUITING · Phase 1
-
CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT
RECRUITING · NA
-
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00912041 · 27 participants · NA
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- NCT02847559 · 27 participants · Phase 2
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
- NCT03380195 · 27 participants · NA
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
- NCT03384238 · 27 participants · Phase 1
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI