Clinical trial for Hematologic Disorders
Official title Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
ClinicalTrials.gov ID: NCT01666080
What this study is testing
What is Busulfan?
Busulfan is an investigational chemotherapy drug being studied as part of a reduced‑intensity conditioning regimen for a second or later allogeneic hematopoietic stem cell transplant in patients with hematologic disorders. It is designed to alkylate DNA, which suppresses the patient's bone marrow and helps donor stem cells engraft.
Also referred to as Busulfex.
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 study aims to see if a reduced‑intensity conditioning plan (busulfan, fludarabine, low‑dose total body irradiation) improves donor cell engraftment after a previous transplant.
- Who it's for
- People who have already had at least one allogeneic stem cell transplant and need another one for a blood disorder.
- What's involved
- Participants will receive busulfan, fludarabine, and low‑dose total body irradiation before receiving a new donor stem cell graft, with follow‑up visits and monitoring.
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 55
You may be able to join if
- Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following...
- Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota...
- Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered.
- Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the...
- Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for...
You likely can't join if
- Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
- Pregnant or breastfeeding
- Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal...
- HIV positive
- While it would be advantageous to begin therapy on this second transplant regimen \> 6 months following a prior myeloablative regimen or \>2 months...
See the full eligibility criteria
- Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT.
- Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
- Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered.
- Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing...
- Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease.
- Age, Performance Status, Consent
- Age: 0 to 55 years
- Consent: voluntary written consent (adult or parental/guardian)
- Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
- Pregnant or breastfeeding
- Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
- HIV positive
- While it would be advantageous to begin therapy on this second transplant regimen \> 6 months following a prior myeloablative regimen or \>2 months after a reduced intensity regimen, it is recognized that there are...
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
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, but 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 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.