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New treatment option for Metabolic Disorders
Official title Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
ClinicalTrials.gov ID: NCT00920972
What this study is testing
What is Treatment Plan 1: Stratum 1?
Treatment Plan 1: Stratum 1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metabolic disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 20
You may be able to join if
- Stratum 1: Patient must have non-malignant disorder, excluding thalassemia. Must be receiving a 8/8 HLA-matched bone marrow, related or unrelated...
- Recipient age \< 21 years
- Lansky/Karnofsky \>/= 40
- Adequate pulmonary, renal, liver, and other organ function as defined in protocol
- Negative pregnancy test
You likely can't join if
- HIV positive
- Invasive infection
- Pregnancy/lactating
See the full eligibility criteria
- Stratum 1: Patient must have non-malignant disorder, excluding thalassemia. Must be receiving a 8/8 HLA-matched bone marrow, related or unrelated Stratum 2: Patient must have thalassemia receiving 8/8 HLA-matched bone...
- Recipient age \< 21 years
- Lansky/Karnofsky \>/= 40
- Adequate pulmonary, renal, liver, and other organ function as defined in protocol
- Negative pregnancy test
- Adequate total nucleated cell or CD34+ dose of product as defined in protocol
- If sickle cell, Hemoglobin S \<30%
- HIV positive
- Invasive infection
- Pregnancy/lactating
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Orange, California, United States
- San Diego, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Orange, California, United States; San Diego, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.