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NCT00145626 · ClinicalTrials.gov registry record · Phase 2
HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
A Phase 2 study of Acute Myeloid Leukemia and Chronic Myeloid Leukemia, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00145626: Completed Phase 2 study of Acute Myeloid Leukemia and Chronic Myeloid Leukemia, sponsored by St. Jude Children's Research Hospital.
NCT00145626 is a Phase 2 study of Acute Myeloid Leukemia and Chronic Myeloid Leukemia that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 40 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00145626, a Phase 2 study of Acute Myeloid Leukemia and Chronic Myeloid Leukemia, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have this donor source available. Another option is haploidentical transplantation using a partially matched family member donor (i.e. parental donor). Although haploidentical transplantation has proven curative for some patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including infection and graft versus host disease (GVHD). Building on prior institutional trials, this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device, CliniMACS selection system. One week after the transplant procedure, patients will also receive an infusion of additional donor derived white blood cells called Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment.
Primary Outcome
The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system. The Kaplan-Meier estimate for
Conditions Studied
Interventions
- DRUG Chemotherapy and antibodies
- DEVICE Miltenyi Biotec CliniMACS
- PROCEDURE Allogeneic stem cell transplantation
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-05 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT00145626 record still lists
NCT00145626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Chemotherapy and antibodies is the first listed.
NCT00145626 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00145626 about?
NCT00145626 is a clinical study titled "HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies". Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have thi...
What is the current status of trial NCT00145626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2004-05. Estimated completion is 2016-07.
What conditions does trial NCT00145626 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Acute Lymphocytic Leukemia, Myelodysplasia, Histiocytosis.
What interventions are being tested in trial NCT00145626?
The interventions under investigation include: Chemotherapy and antibodies (DRUG), Miltenyi Biotec CliniMACS (DEVICE), Allogeneic stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00145626?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00145626 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00145626's enrollment target sits among peer trials
40 170th of 306 higher than 128 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid 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.
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