Study on Using Expanded Cord Blood Cells with Single Cord Blood Transplant for Treating Blood Cancers

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03399773

Provider View

This clinical trial is exploring a new treatment approach for patients with certain blood cancers, using a combination of expanded cord blood cells and a single cord blood transplant. The study aims to see if this method can effectively treat patients with acute leukemia, chronic myeloid leukemia, or myelodysplastic syndromes.

Patient Parameters

Program Overview

This study is testing a new way to treat blood cancers by using a combination of expanded cord blood cells and a single cord blood transplant. Before the transplant, patients will receive chemotherapy and radiation to prepare their bodies. This preparation helps stop the growth of cancer cells and makes it easier for the new healthy cells to take hold. The goal is for the donor's healthy stem cells to help the patient's bone marrow produce new blood cells and replace the patient's immune cells, potentially destroying any remaining cancer cells.

Description

In this study, patients will receive one of two treatment plans:

Plan A:

  • For patients aged 10 to 45 years.
  • Receive chemotherapy drugs fludarabine and cyclophosphamide through an IV.
  • Undergo total body irradiation (TBI) twice daily for four days.
  • Receive a cord blood transplant followed by expanded cord blood cells (dilanubicel) within 24 hours.

Plan B:

  • For patients aged 10 to 65 years.
  • Receive chemotherapy drugs fludarabine, cyclophosphamide, and thiotepa through an IV.
  • Undergo TBI once daily for two days.
  • Receive a cord blood transplant followed by expanded cord blood cells (dilanubicel) within 24 hours.

All patients will have bone marrow tests and scans as needed, and blood samples will be collected during the study. After treatment, patients will have follow-up visits at 180 days, 1 year, and 2 years to monitor their health and progress.

Eligibility Criteria

Inclusion Criteria

  • Aged 10 to 65 years with a blood cancer needing a stem cell transplant and weighing more than 30 kg.
  • No suitable related donor available.
  • Diagnosed with specific types of blood cancers, such as acute leukemia or chronic myeloid leukemia, and meeting certain health criteria.
  • For patients aged 10 to 45 years, a performance status score of 70 or higher.
  • For patients aged 46 to 65 years, a performance status score of 70 or higher and a low comorbidity index.
  • Adequate kidney and liver function as shown by specific blood tests.
  • Good lung and heart function.
  • Ability to understand and sign a consent form.
  • Donor cord blood must meet specific matching and cell count criteria.

Exclusion Criteria

  • Uncontrolled viral or bacterial infections.
  • Recent or active serious fungal infections.
  • History of HIV infection.
  • Pregnant or breastfeeding women.
  • Previous stem cell transplant.
  • Cancer in the central nervous system that does not respond to treatment.
  • Weighing less than 30 kg.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.