Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 11, 2019

Keywords

ClinConnect Summary

The COmPACt Study is a clinical trial that is looking into a new way to improve cord blood transplantation for patients with certain blood cancers, known as hematological malignancies. The trial aims to explore a method that might reduce complications after the transplant, like a condition called graft-versus-host disease (GvHD), which can occur when the donated cells attack the patient's body. By using a specific type of medication called post-transplant cyclophosphamide, researchers hope to enhance the safety and effectiveness of the transplant process.

To participate in this trial, individuals must be between 18 and 75 years old and have a specific type of cord blood unit that meets certain requirements. They should also have a diagnosis of certain blood cancers, such as acute myeloid leukemia or non-Hodgkin's lymphoma, among others. Participants can expect to undergo a conditioning treatment before the transplant and receive ongoing care post-transplant to monitor their health. It’s important to note that individuals with certain infections, such as HIV or active hepatitis, cannot participate in the study. Overall, this trial is a step towards finding better treatment options for patients needing cord blood transplants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: ≥ 18 ≤ 75 years old
• • CB unit transplantation (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA matched)
• • Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine
• • GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF
• • Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.
• Exclusion Criteria:
• • Positive serologic markers for human immunodeficiency virus (HIV)
• • Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection