Protocol
HIFLEX: A Reduced Intensity Conditioning Regimen with CD3-Depleted Hematopietic Stem Cells to Improve Survival for Patients with Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation
Diseases
Leukemias / Lymphomas : Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Juvenile Myelomonocytic Leukemia (JMML), Paroxysmal Nocturnal Hemoglobinuria (PNH), Hodgkin lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic Syndrome (MDS)
Description
Stem cell transplants involving a normal donor and a patient recipient is clinically referred to as an Allogeneic hematopoietic stem cell transplant. Allogeneic stem cell transplants have improved the outcome for patients with high-risk hematologic cancers. Although stem cell transplants are the preferred treatment for these cancers, many patients are unable to undergo an allogeneic transplant due to the lack of a matched donor. Stem cells are immature blood cells in the bone marrow and circulating blood stream that grow to become red blood cells, white blood cells or platelets.
In this study subjects who do not have matched transplant donors will receive stem cells from a family member who is called a “partially matched family member donor.” Additionally, patients will receive anti-cancer medications to prepare them for transplant and be followed closely after the stem cell infusion. By transplanting subjects with family member donor cells the burden of disease might decrease and/or go into remission but when conducting mismatched transplants there are additional risks that might impact the patients’ quality of life. Active treatment for this study lasts approximately 4-6 months while routine evaluations and follow-up will continue for approximately five years after transplantation. Patients who receive transplant at St Jude will be asked to return to clinic once yearly for ten years.
Objectives
- To determine if the event-free survival, at one year post-HSCT, can be improved for patients receiving this regimen
- To evaluate the one-year overall survival and disease free survival for participants with high-risk hematologic cancers who receive this study regimen
Eligibility
- Patient is less than or equal to 21 years of age
- Has one of the following diagnoses: ALL in remission; high risk, relapsed or persistent AML; CML in chronic phase; JMML; MDS; PNH; Hodgkin lymphoma; non-Hodgkin lymphoma; MDS
- Has not received a prior allogeneic hematopoietic stem cell transplant
- No suitable HLA-matched or matched unrelated donor (MUD) available
- A suitable partially matched family member donor who is at least 18 years of age is available
- Participants meets other requirements defined in the eligibility portion of the study
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
Contact
Brandon Triplett, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068
Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.