Donor Stem Cell Transplant with Treosulfan, Fludarabine, and Total-Body Irradiation for Treating Blood Cancers

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04195633

Provider View

This study is testing a treatment for blood cancers using a combination of chemotherapy, radiation, and donor stem cell transplant. The goal is to see if this approach can effectively treat blood cancers by replacing the patient's bone marrow and immune cells with healthy ones from a donor.

Patient Parameters

Program Overview

This phase II study is exploring how well a combination of treatments works for patients with blood cancers. The treatment includes chemotherapy drugs (treosulfan and fludarabine), total-body irradiation, and a stem cell transplant from a donor. The chemotherapy and radiation help prepare the body by stopping the growth of cancer cells and normal bone marrow cells. This preparation also helps the body accept the new stem cells from the donor. Once the donor's healthy stem cells are infused, they can help the patient's bone marrow produce new blood cells and replace the immune cells to fight any remaining cancer.

Description

In this study, patients are divided into two groups based on the dose of treosulfan they receive.

Group A (High Dose Treosulfan):

  • Patients receive high doses of treosulfan through an IV for three days, followed by fludarabine for five days.
  • They then undergo total-body irradiation and receive a stem cell transplant from a donor.
  • After the transplant, patients receive cyclophosphamide for two days to help prevent complications.
  • Starting on day 5, patients take cyclosporine and mycophenolate to prevent rejection of the donor cells and filgrastim to help increase white blood cell counts.
  • Patients also undergo various tests, including bone marrow biopsies and imaging scans.

Group B (Low Dose Treosulfan):

  • Patients receive lower doses of treosulfan but follow the same treatment plan as Group A.

After the transplant, patients are monitored at several intervals over two years to assess their recovery and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with certain types of blood cancers, such as acute leukemia, chronic myelogenous leukemia, or lymphoma, and in remission or partial remission.
  • At least 6 months old.
  • Good overall health with a performance status score indicating the ability to perform daily activities.
  • Adequate heart and lung function.
  • Normal liver and kidney function based on specific blood tests.
  • No recent severe infections.
  • Previous stem cell transplant allowed if it was at least 3 months ago.
  • Must have a suitable donor who is a close relative and matches certain genetic markers.
  • Donor must be at least 12 years old and meet specific health criteria.

Exclusion Criteria

  • Active, uncontrolled infections requiring treatment.
  • Another life-threatening cancer with a poor prognosis.
  • Pregnant or breastfeeding.
  • Allergic to any of the study drugs.
  • Recently received another experimental treatment.
  • Cancer spread to the brain that hasn't been controlled with treatment.
  • Donor-specific antibodies that could increase the risk of transplant rejection.

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