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Clinical trials
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- Active clinical trials for pediatric cancers
- CAR-20/19-T cells in pediatric and young adult patients with relapsed/refractory B Cell Acute Lymphoblastic Leukemia (CAR-20/19-T) phase 1 clinical trial
- Unrelated and partially matched related donor peripheral stem cell transplantation for patients with hematologic malignancies clinical trial
- Early stage research
Active clinical trials
Cancer Clinical Trials - BMTCTN-1904
Protocol Summary
- Protocol No
- BMTCTN-1904
- Principal Investigator
- Julie-An Talano
- Phase
- II
- Title
- BMTCTN-1904 Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases
- Associated Disease(s)
-
Early Phase Trials (Phase I and II)
- Description (Summary)
- We are doing this study to find out if the drug treosulfan, given with fludarabine and rATG as the conditioning regimen before a blood or marrow transplant (BMT) will cause fewer complications and result in a more successful BMT than the standard of care conditioning regimen without treosulfan.
In the past, patients with bone marrow failure disorders often had poor outcomes after a BMT. These patients had a high risk of organ damage from the chemotherapy (and radiation, if used) in the conditioning regimen. As well, sometimes the transplanted bone marrow cells did not take and grow into healthy blood cells, causing graft rejection.
Treosulfan is a chemotherapy drug. In Europe, it has been used as part of the conditioning regimen before a BMT for almost a decade. In the United States, it has been used in clinical trials for patients with bone marrow failure diseases undergoing a BMT for several years. The results of these studies using treosulfan show that it causes less damage to organs and yet is strong enough for the transplanted cells to grow.
Treosulfan has not been approved by the U.S. Food and Drug Administration (FDA) as there needs to be more clinical trial results to confirm that it is a safe and effective chemotherapy drug to use in BMT. This research study is registered with the FDA, and they will monitor this study.
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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