Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Overseen By Caitlin Guzowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northside Hospital, Inc.

Disqualifiers: Poor cardiac, pulmonary, liver, renal function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.

Research Team

Scott Solomon, MD

Principal Investigator

BMTGA

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive reduced intensity conditioning with fludarabine and total body irradiation (TBI) 800 cGy

1-2 weeks

Transplantation

Haplo-identical transplantation using peripheral blood stem cells (PBSC) is performed

1 week

Follow-up

Participants are monitored for safety and effectiveness after transplantation

12 weeks

Treatment Details

Interventions

• Fludarabine
• Haplo-Identical Transplantation
• Total Body Irradiation (TBI)

Fludarabine is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Fludara for:

• Chronic lymphocytic leukemia
• Mantle-cell lymphoma
• Non-Hodgkin's lymphoma

Approved in United States as Fludara for:

• Chronic lymphocytic leukemia
• Non-Hodgkin's lymphoma
• Stem Cell Transplant Conditioning

Approved in Canada as Fludara for:

• Chronic lymphocytic leukemia
• Non-Hodgkin's lymphoma

Who Is Running the Clinical Trial?

Northside Hospital, Inc.

Lead Sponsor

Trials

26

Recruited

1,100+