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NCT00622895 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00622895 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 3 participants.
The verdict
NCT00622895, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of the study is to examine the safety and effectiveness of a reduced intensity conditioning regimen and allogeneic bone marrow transplant for people with systemic sclerosis. In an allogeneic bone marrow transplant procedure, bone marrow is taken from a healthy donor and transplanted into the patient. Bone marrow can be donated by a family member or an unrelated donor who is a complete tissue type match. Participants will receive the chemotherapy and low dose radiation conditioning regimen consisting of the following: Fludarabine will be given intravenously for 5 days. Cyclophosphamide will be given intravenously on the first and second day. After completing the fludarabine and cyclophosphamide, patients will receive a single low dose of total body irradiation. The next day, patients will receive the allogeneic bone marrow transplant. On the third and fourth day after the transplant, patients will receive high dose intravenous cyclophosphamide. This is given to help prevent two complications: (1) graft rejection, which occurs when the body's immune system rejects the donor bone marrow, and (2) graft-versus-host disease (GVHD), which is when the donor immune cells attack the patient's normal tissues. On the fifth day after the transplant, patients will start receiving two additional medications: tacrolimus and mycophenolic acid (MPA, Myfortic), to help prevent GVHD. Patients will receive mycophenolic acid for about 5 weeks and tacrolimus for about 6 months. Also beginning on the fifth day after the transplant, patients will receive daily injections of a growth factor called granulocyte-colony stimulating factor (G-CSF), which is a protein that increases the white blood cell count; G-CSF will be continued until the patient's white blood cell count has returned to normal levels. Patients will remain closely monitored either in the outpatient clinic setting or in the hospital for approximately 2-3 months after the transplant, but possibly longer if there ar
Interventions
- DRUG fludarabine phosphate
- DRUG tacrolimus
- RADIATION total-body irradiation
- DRUG Mycophenolic Acid
- PROCEDURE bone marrow transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2006-09-01 |
| Est. Completion | 2017-08-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00622895
The ClinicalTrials.gov registry entry for NCT00622895 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00622895 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00622895 about?
NCT00622895 is a clinical study titled "Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis". The purpose of the study is to examine the safety and effectiveness of a reduced intensity conditioning regimen and allogeneic bone marrow transplant for people with systemic sclerosis. In an allogeneic bone marrow transplant procedure, bone marrow is taken from a healthy donor and transplanted into...
What is the current status of trial NCT00622895?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2006-09-01. Estimated completion is 2017-08-01.
What interventions are being tested in trial NCT00622895?
The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), total-body irradiation (RADIATION), Mycophenolic Acid (DRUG), bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00622895?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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