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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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)
Step 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 trial?

9 criteria

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)
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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 trial?

15 criteria

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

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Verified sites

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Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Cracow, Poland

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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.

Cladribine

What is already known about the treatment

Cladribine - A chemotherapy medication administered via injection or infusion that belongs to the class of purine analogs used in the treatment of blood cancers, particularly acute myeloid leukemia and myelodysplastic syndromes. The drug works by interfering with DNA synthesis in cancer cells, preventing them from dividing and ultimately leading to their death. Cladribine is often used in combination with other treatments, such as total body irradiation, as part of conditioning regimens before hematopoietic cell transplantation, and has shown significant effectiveness in clinical trials for blood disorders.

Investigated diseases

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.