Study Comparing Treosulfan-Based and Clofarabine-Based Preparations Before Stem Cell Transplant for Treating Myelodysplastic Syndromes or Acute Myeloid Leukemia

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04994808

Provider View

This clinical trial is exploring two different chemotherapy preparations, treosulfan-based and clofarabine-based, to see which is more effective before a stem cell transplant in patients with myelodysplastic syndromes or acute myeloid leukemia.

Patient Parameters

Program Overview

The study aims to determine whether a treosulfan-based or clofarabine-based chemotherapy regimen is more effective when given before a stem cell transplant in patients with myelodysplastic syndromes or acute myeloid leukemia. These chemotherapy drugs work by stopping cancer cells from growing and spreading. The treatment involves chemotherapy and total-body irradiation to kill cancer cells and prepare the bone marrow for new, healthy stem cells from a donor. These donor stem cells can help the patient's bone marrow produce healthy blood cells and may also help eliminate any remaining cancer cells.

Description

In this study, patients are randomly assigned to one of two treatment groups:

Group A:

  • Receive treosulfan through an IV for 2 hours on days -6 to -4.
  • Receive fludarabine through an IV for 30 minutes on days -6 to -2.
  • Undergo total-body irradiation (TBI) and receive a stem cell transplant on day 0.
  • Undergo heart and lung tests, as well as bone marrow and blood tests before and after the transplant.

Group B:

  • Receive clofarabine through an IV for 2 hours on days -6 to -2.
  • Undergo TBI and receive a stem cell transplant on day 0.
  • Undergo heart and lung tests, as well as bone marrow and blood tests before and after the transplant.

After the treatment, patients will have follow-up visits on days 28, 56, 84, and 180, and then annually for up to 5 years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 75 years.
  • Diagnosed with myelodysplastic syndromes (MDS-EB) or acute myeloid leukemia (AML) with less than 5% cancer cells in the bone marrow at the time of transplant.
  • Have a performance score of 60% or higher, indicating the ability to carry out daily activities.
  • Able to provide informed consent.
  • May have had a previous stem cell transplant.
  • Have a donor who is a close match and can provide stem cells from the blood.
  • Donors must be able to undergo a procedure to collect stem cells from the blood.

Exclusion Criteria

  • Have cancer cells circulating in the blood.
  • Have more than 5% cancer cells in the blood for MDS-EB patients.
  • Have a specific type of leukemia called promyelocytic AML.
  • Have significant organ dysfunction, such as severe heart, lung, kidney, or liver problems.
  • Have active infections that require delaying treatment.
  • Have fungal infections that are not responding to treatment.
  • Have HIV or active hepatitis infections.
  • Have cancer in the central nervous system.
  • Have other active cancers or a high risk of cancer recurrence.
  • Have a life expectancy limited by other diseases.
  • Are pregnant, breastfeeding, or unwilling to use contraception.
  • Have allergies to the study drugs.
  • Are unable to provide informed consent.
  • Are suitable for and willing to receive a standard high-intensity treatment.
  • Have a donor who cannot provide blood stem cells or has certain medical conditions that increase risk.
  • Have a donor with immune reactions that could affect the transplant success.

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