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Study of Total Body Irradiation and Cladribine Treatment Before Stem Cell Transplant in Adult Patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes

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What is this study about?

This study focuses on patients with Acute Myeloid Leukemia and Myelodysplastic Syndromes, which are serious blood disorders affecting bone marrow function. The study evaluates a treatment combination that includes Total Body Irradiation and a medication called Cladribine before patients undergo a Allogeneic Hematopoietic Cell Transplantation, which is a procedure where patients receive blood-forming stem cells from a matched donor.

The purpose is to determine how well patients tolerate this treatment combination and how effective it is in preventing disease progression. The treatment involves receiving Cladribine through an infusion into a vein, with a maximum daily dose of 5 milligrams per square meter of body surface area. The total treatment period lasts 5 days, with a maximum total dose of 25 milligrams per square meter.

During this study, patients will receive the treatment combination before their stem cell transplant procedure. The treatment involves both radiation therapy that targets the entire body and the infusion of Cladribine medication. After the transplant, patients will be monitored for a period of 24 months to evaluate their recovery and the treatment’s effectiveness.

1 Initial evaluation

Your health status will be assessed with ECOG performance test (a measure of your ability to perform daily activities)

Medical team will confirm your eligibility based on age (18-60 years) and diagnosis of acute myeloid leukemia or myelodysplastic syndrome

2 Pre-transplant treatment

You will receive total body irradiation (radiation therapy to your entire body)

Treatment with cladribine (BIODRIBIN) will be administered through infusion at 1 mg/ml

3 Stem cell transplantation

You will undergo allogeneic hematopoietic cell transplantation (receiving blood-forming stem cells from a matched donor)

The donor may be a sibling, unrelated matched donor, or partially matched family member

4 Post-transplant monitoring

Medical team will monitor your blood counts to check for successful cell growth

Regular checks will be performed for signs of graft-versus-host disease (a condition where transplanted cells react against your body)

5 Long-term follow-up

Your progress will be monitored for 24 months after transplantation

Regular health assessments will check for disease progression and any side effects

The study will continue until January 31, 2027

Who Can Join the Study?

  • Age must be between 18 and 60 years old
  • Must be diagnosed with acute myeloid leukemia (intermediate or high risk in complete remission, or low risk with positive minimal residual disease) or high risk myelodysplastic syndrome
  • Must be eligible for allogeneic stem cell transplantation (a procedure where stem cells from a matched donor are transferred to the patient)
  • Must have shown positive response to previous treatment with cladribine (a type of chemotherapy medication)
  • Must have an ECOG performance status of 0 or 1 (meaning able to carry out all normal activities with minimal or no symptoms)
  • Must have a suitable stem cell donor who is either:
    • A matched sibling
    • A matched unrelated donor (fully matched or 9/10 match)
    • A half-matched family donor (haploidentical)
  • Must be willing and able to sign an informed consent form before any study procedures begin

Who Cannot Join the Study?

  • Age below 18 years old
  • Pregnancy or breastfeeding women
  • Previous treatment with total body irradiation
  • Active, uncontrolled infections
  • Severe heart conditions (such as heart failure, recent heart attack, or uncontrolled irregular heartbeat)
  • Severe kidney problems (kidney failure requiring dialysis)
  • Severe liver problems (liver failure or cirrhosis)
  • Active second cancer (other than skin cancer)
  • Participation in another clinical trial within the last 30 days
  • Mental conditions that prevent understanding of the study requirements
  • Known allergy or hypersensitivity to cladribine (the study medication)
  • Uncontrolled diabetes mellitus (high blood sugar)
  • History of organ transplantation
  • Severe lung disease that significantly affects breathing
  • HIV infection, active hepatitis B or C

Where you can join this trial?

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Site Name City Country Status
Nlwauoyy Ifaqxxml Omhktuhkm Itw Mknzv Stdwpkrlmfdtndtqjyqilneywrjb Idrxisqa Boaiylbf Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
17.02.2022

Trial locations

Investigated drugs:

Cladribine is a chemotherapy medication used to treat blood cancers. It works by slowing or stopping the growth of cancer cells in the body. In this trial, it is being studied as part of the preparation treatment before stem cell transplantation.

Total Body Irradiation (TBI) is a form of radiation therapy that delivers radiation to the entire body. It is used to prepare the body for stem cell transplantation by suppressing the immune system and eliminating remaining cancer cells. TBI is not a medication but rather a treatment procedure that uses radiation.

The combination of Cladribine and Total Body Irradiation is being tested as a preparatory treatment (conditioning regimen) for patients who will receive stem cells from a donor (allogeneic transplantation) to treat their acute myeloid leukemia or myelodysplastic syndromes.

Acute Myeloid Leukemia – A blood and bone marrow cancer where the body produces abnormal white blood cells that don’t function properly. The disease develops rapidly, with immature blood cells (called blasts) building up in the bone marrow and blood. These abnormal cells interfere with the production of normal blood cells, leading to decreased numbers of healthy white blood cells, red blood cells, and platelets. The condition typically develops quickly over days or weeks.

Myelodysplastic Syndromes – A group of blood disorders where blood-forming cells in the bone marrow become abnormal and fail to produce enough healthy blood cells. The condition causes the bone marrow to produce poorly formed or dysfunctional blood cells. Over time, the number of immature blood cells (blasts) increases while the number of healthy blood cells decreases. This leads to various health issues related to low blood cell counts.

Trial ID:
2024-517477-24-00
Protocol code:
20-NIO-0001
NCT ID:
NCT04861207
Trial Phase:
Therapeutic exploratory (Phase II)

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