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NCT00602693 · ClinicalTrials.gov registry record · Phase 1
T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer
A Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT00602693: Completed Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00602693 is a Phase 1 study of Multiple Myeloma and Lymphoma that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 41 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602693, a Phase 1 study of Multiple Myeloma and Lymphoma, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory cells after the transplant may decrease this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. However, the donor immune system may also react against the recipient's tissues (graft-versus-host disease). PURPOSE: This phase I trial is studying the side effects and best dose of donor T-regulatory cells after an umbilical cord blood transplant in treating patients with advanced hematologic cancer or other disorder.
Primary Outcome
Nine dose levels of CD4+CD25+ Treg are scheduled with the doses being 1, 3, 10, 30, 30+30, 100, 300, 1000, and 3000 x 10\^5 Treg/kg recipient body weight. The dose escalation will proceed in cohorts of one patient until the first dose limiting toxicity (DLT) is observed.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Allopurinol
- RADIATION Total body irradiation
- DRUG fludarabine phosphate
- BIOLOGICAL umbilical cord blood transplantation
Study Locations (1)
Minnesota
- Masonic Cancer Center at University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2007-07-23 |
| Est. Completion | 2015-04-16 |
| Phase | Phase 1 |
What the finished NCT00602693 record still lists
NCT00602693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00602693 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00602693 about?
NCT00602693 is a clinical study titled "T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer". RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help des...
What is the current status of trial NCT00602693?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2007-07-23. Estimated completion is 2015-04-16.
What conditions does trial NCT00602693 study?
This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Leukemia, Myelodysplastic Syndromes, Plasma Cell Neoplasm.
What interventions are being tested in trial NCT00602693?
The interventions under investigation include: Cyclophosphamide (DRUG), Allopurinol (DRUG), Total body irradiation (RADIATION), fludarabine phosphate (DRUG), umbilical cord blood transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00602693?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602693 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
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 NCT00602693's enrollment target sits among peer trials
41 285th of 438 higher than 151 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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