Study on Cord Blood Transplant with Chemotherapy and Radiation for Treating High-Risk Blood Diseases

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06013423

Provider View

This clinical trial is exploring the effectiveness of using umbilical cord blood transplants combined with chemotherapy and radiation to treat patients with high-risk blood diseases. The treatment aims to stop cancer growth and help the patient's body accept healthy donor cells.

Patient Parameters

Program Overview

This study is testing a treatment that combines umbilical cord blood transplants with chemotherapy drugs (cyclophosphamide, fludarabine, and thiotepa) and total-body irradiation (TBI) to treat high-risk blood diseases. The chemotherapy and radiation help stop cancer cells from growing and prepare the body to accept new, healthy stem cells from a donor. These donor cells can help the patient's bone marrow produce new blood cells. To prevent the donor cells from attacking the patient's body, medications like cyclosporine and mycophenolate mofetil are given after the transplant.

Description

The study has two groups based on age:

Group 1 (Ages 6 months to 30 years):

  • Patients receive chemotherapy drugs fludarabine and cyclophosphamide, and high-dose radiation over several days.
  • They then receive a cord blood transplant.
  • Patients undergo various tests, including blood tests and heart scans, throughout the study.

Group 2 (Ages 6 months to 65 years):

  • Patients receive chemotherapy drugs fludarabine, cyclophosphamide, and thiotepa, along with moderate-dose radiation.
  • They also receive a cord blood transplant and undergo similar tests as Group 1.

After the transplant, all patients receive medications to prevent the donor cells from attacking their body. These include cyclosporine and mycophenolate mofetil, which are gradually reduced if there are no signs of complications.

Patients are monitored at specific intervals after treatment to assess their health and the success of the transplant.

Eligibility Criteria

Inclusion Criteria

  • Ages 6 months to 65 years.
  • Diagnosed with certain high-risk blood cancers like acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) in specific stages of remission.
  • Other eligible conditions include chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), and certain types of non-Hodgkin lymphoma (NHL).
  • Must have good overall health and organ function, including heart, liver, and kidney health.
  • Must have a specific level of blood cell counts and other health markers.
  • Must be able to provide a suitable umbilical cord blood unit for transplant.
  • Must not have any active infections or other health conditions that would interfere with the treatment.

Exclusion Criteria

  • Diagnosed with myelofibrosis or other cancers with significant bone marrow issues.
  • Active cancer in the central nervous system.
  • Previous treatment with certain immune therapies in the last year.
  • More than one previous stem cell transplant.
  • Recent or previous radiation therapy that would interfere with the study treatment.
  • Active, uncontrolled infections or HIV.
  • Poor overall health or organ function.
  • Pregnant or breastfeeding women.
  • Inability to provide informed consent or follow the study protocol.

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