Spots Global Cancer Trial Database for A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
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Trial Identification
Brief Title: A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
Official Title: Pre-Transplant Immune Suppression With Hematopoietic Cell Transplantation From Haploidentical Donors for Adults and Children With Sickle Cell Disease or ß-Thalassemia (Haplo PTCy)
Study ID: NCT05736419
Study Description
Brief Summary: Hematopoietic Cell Transplantation/HCT involves receiving healthy blood-forming cells (stem cells) from a donor to replace the diseased or damaged cells in participants' bone marrow. The researchers think giving participants treatment with fludarabine and dexamethasone, drugs that lower the activity of the body's immune system (immune suppression), before standard conditioning therapy and HCT may help prevent serious side effects, including graft failure and GvHD. In this study, depending on how participants' body responds to the fludarabine and dexamethasone, the study doctor may decide participants should receive another drug, called cyclophosphamide, instead of fludarabine. In addition, depending on the results of participants' routine blood tests, participants may receive the drugs bortezomib and rituximab, which also help with immune suppression.
Detailed Description:
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only), Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent only), Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Consent only), Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only), Harrison, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities), Rockville Centre, New York, United States
Contact Details
Name: Maria Cancio, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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