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NCT00520130 · ClinicalTrials.gov registry record · Phase 1
Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System
A Phase 1 study of Multiple Myeloma and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT00520130: Completed Phase 1 study of Multiple Myeloma and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
NCT00520130 is a Phase 1 study of Multiple Myeloma and Myelodysplastic Syndrome that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 92 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00520130, a Phase 1 study of Multiple Myeloma and Myelodysplastic Syndrome, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of suitable donors for patients without a human leukocyte-antigen (HLA) tissue-matched sibling and graft-versus-host disease (GVHD), a serious side effects of immune-suppressing chemotherapy that is given to bring the cancer under control before SCT. In GVHD, the patients immune system attacks the transplanted donor cells. This study will try to improve the results of SCT from unrelated HLA-matched donors using targeted immune-depleting chemotherapy to bring the cancer under control before transplantation and to lower the chance of graft rejection, followed by reduced-intensity transplant chemotherapy to make the procedure less toxic. Objectives: To evaluate the safety and effectiveness of targeted immune-depleting chemotherapy followed by reduced-intensity transplant chemotherapy in patients with advanced cancers of the blood and immune system. To evaluate the safety and effectiveness of two different drug combinations to prevent GVHD. Both regimens have been successful in preventing GVHD, but they work by different mechanisms and affect the rebuilding of the immune system after the transplant. Eligibility: People 18 to 74 years of age with advanced or high-risk cancers of the blood and immune system who do not have a suitable HLA-matched sibling. Design: All patients receive chemotherapy before transplant to treat the cancer and suppress immune function. All patients receive a conditioning regimen of cyclophosphamide for 4 days and fludarabine for 4 days before SCT to prepare for the transplant. Patients are randomly assigned to one of two combination drug treatments to prevent GHVD as follows: * Group 1: Tacrolimus starting 3 days before SCT and continuing for 6 months, plus methotrexate on days 1, 3, 6, and 11 post-SCT, plus sirolimus starting 3 days before the SCT and continues for 6 months following SCT. * Group 2: Alemtuzumab for 4 days starting 8 days
Primary Outcome
Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.
Conditions Studied
Interventions
- BIOLOGICAL Rituximab
- DRUG Conditioning Chemotherapy
- DRUG Cyclosporine
- DRUG Allogenic stem cell transplant (ASCT)
- DRUG TMS
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2007-10-30 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 1 |
What the finished NCT00520130 record still lists
NCT00520130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (83% lower).
The record links to 5 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT00520130 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00520130 about?
NCT00520130 is a clinical study titled "Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System". Background: Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of suitable donors for patients without a human leukocyte-antigen (HLA) tissue-matched sibling and graft-versus-host disease (GVHD), a serious side effects of immune-suppressing chemotherapy that is give...
What is the current status of trial NCT00520130?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2007-10-30. Estimated completion is 2018-12-31.
What conditions does trial NCT00520130 study?
This clinical trial studies the following conditions: Multiple Myeloma, Myelodysplastic Syndrome, Acute Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Disease.
What interventions are being tested in trial NCT00520130?
The interventions under investigation include: Rituximab (BIOLOGICAL), Conditioning Chemotherapy (DRUG), Cyclosporine (DRUG), Allogenic stem cell transplant (ASCT) (DRUG), TMS (DRUG).
Who is sponsoring clinical trial NCT00520130?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00520130 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00520130's enrollment target sits among peer trials
92 181st of 438 higher than 256 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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