Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Launched by NORTHSIDE HOSPITAL, INC. · Jun 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with blood cancers, known as hematologic malignancies. The treatment involves a reduced intensity transplant using a combination of a medication called fludarabine and a form of radiation therapy (TBI) to prepare patients for a stem cell transplant from a closely matched relative. The goal is to see how safe and effective this method is in helping patients recover and avoid relapse.

To participate in the trial, patients typically need to be between the ages of 65 and 74 and must have a relative who can donate stem cells. Additionally, they should have a good performance status, meaning they can generally take care of themselves. However, there are certain health conditions that may exclude someone from participating, such as serious heart, lung, liver, or kidney problems, as well as active infections or certain viral infections like HIV. If eligible, participants can expect to receive the new treatment protocol and will be closely monitored throughout the trial to ensure their safety and health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells
• • KPS \>/= 70%
• • Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.
• Exclusion Criteria:
• • Poor cardiac function (LVEF \<45%)
• • Poor pulmonary function (FEV, FVC, DLCO \<60%)
• • Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN)
• • Poor renal function (creatinine clearance \<40mL/min)
• • HIV-positive; active HepB or HepC
• • Uncontrolled infection
• • Pregnant female or not able to practice adequate contraception
• • Debilitating medical or psychiatric illness which would preclude their giving informed consent