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Study on Cyclophosphamide and Etoposide with Radiation for High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Patients Preparing for Transplant

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What is this trial about?

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

This clinical trial is focused on patients with High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia, which are serious blood disorders. The study is investigating a treatment approach that combines chemotherapy and radiotherapy to prepare patients for a bone marrow transplant. The chemotherapy drugs used in this study include Cyclophosphamide and Etoposide, which are known as immunosuppressive agents. These drugs help to suppress the immune system, making it easier for the body to accept the new bone marrow. The study also involves the use of Mycophenolate Mofetil, Sirolimus, and Tacrolimus, which are additional immunosuppressive agents that help prevent the body from rejecting the transplanted bone marrow.

The purpose of this study is to evaluate the effectiveness of this treatment combination in improving the chances of survival without the disease getting worse for two years after the treatment. Participants will receive the treatment over a period of time, which includes the administration of the drugs and the bone marrow transplant. The study will monitor the participants' health and progress, focusing on how well the treatment works and any side effects that may occur. The study aims to provide valuable information on the potential benefits and risks of this treatment approach for patients with these high-risk blood disorders.

Throughout the study, participants will be closely observed to ensure their safety and to gather data on the treatment's impact. This includes regular check-ups and assessments to track the progression of the disease and the overall health of the participants. The study will also look at the occurrence of any infections, the response of the body to the new bone marrow, and any other health changes that may arise during and after the treatment. The ultimate goal is to find a more effective way to prepare patients for a bone marrow transplant, potentially improving outcomes for those with High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will undergo initial assessments to confirm eligibility. This includes tests to evaluate lung and heart function, as well as a pregnancy test for women of childbearing age.
Step 2
Conditioning regimen
The conditioning regimen involves a combination of chemotherapy and radiation therapy. This phase prepares the body for the bone marrow transplant.
Medications used include cyclophosphamide and etoposide, administered through infusion. The exact dosage and frequency will be determined by the medical team.
Step 3
Total marrow and lymphoid irradiation (TMLI)
TMLI is a specialized form of radiation therapy targeting the bone marrow and lymphoid tissues. This step is crucial for eliminating existing bone marrow cells to make room for new, healthy cells.
Step 4
Allogeneic hematopoietic stem cell transplantation (AHSCT)
Following the conditioning regimen, the participant will receive a transplant of healthy stem cells from a matched donor. This process is essential for rebuilding the bone marrow with healthy cells.
Step 5
Post-transplant monitoring
After the transplant, the participant will be closely monitored for any signs of complications or infections. Regular assessments will be conducted to evaluate the success of the transplant and the participant's overall health.
Medications such as mycophenolate mofetil, sirolimus, and tacrolimus may be administered orally or through intravenous infusion to support the immune system and prevent rejection of the transplanted cells.
Step 6
Follow-up evaluations
The participant will undergo regular follow-up evaluations to assess progression-free survival and overall health. These evaluations will continue for up to two years post-transplant to monitor for any long-term effects or recurrence of the disease.

Who can join the trial?

13 criteria

The participant must be able and willing to sign a document that shows they agree to join the study.
Breathing tests must show that the participant's lung function is at least 50% of what is expected for a healthy person.
The participant must have a heart test, like an electrocardiogram (ECG), showing no serious heart problems and a heart pumping ability of at least 50%.
Men and women who can have children must agree to use birth control methods or not have sex during the study and for six months after.
At least 14 days must have passed since the participant's last treatment cycle ended.
The participant must be between 18 and 50 years old.
The participant's ability to perform daily activities should be at least 70% of normal, as measured by a specific scale called Karnofsky's performance status.
The participant must have a specific type of blood disorder or leukemia, either active or in remission, with certain measurable disease levels.
The participant must have a matching sibling or unrelated donor willing to donate bone marrow or blood cells for the study.
The participant's liver function tests must be within certain limits, with total bilirubin levels not exceeding 1.5 times the normal limit, or 3 times for those with Gilbert's disease.
The participant's liver enzymes, SGOT and SGPT, must be no more than 5 times the normal limit.
The participant's kidney function must be within certain limits, with serum creatinine levels not exceeding 1.3 mg/dL or a creatinine clearance of at least 80 mL/min.
Women who can have children must have a negative pregnancy test before joining the study.

Who cannot join the trial?

1 criterion

Patients with a **High-Risk Myelodisplastic Syndrome** or **Acute Myeloid Leukemia** cannot participate. These are specific types of blood disorders.

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Virgen del Rocío University Hospital
Sevilla, Spain

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Investigated drugs

Cyclophosphamide
is a medication used in this trial as part of the conditioning regimen before stem cell transplantation. It works by slowing or stopping the growth of cancer cells and is used to help prepare the body to receive new stem cells.
Etoposide
is another medication included in the conditioning regimen. It helps to kill cancer cells by interfering with their DNA, making it easier for the body to accept the new stem cells during transplantation.
Total Marrow and Lymphoid Irradiation (TMLI)
is a type of radiation therapy used in this trial. It targets the bone marrow and lymphoid tissues to destroy cancer cells and create space for the new stem cells to grow and develop after transplantation.

What is already known about the treatment

Cyclophosphamide
Cyclophosphamide is administered intravenously and is currently used in medical practice as part of a conditioning regimen for allogeneic hematopoietic stem cell transplantation. It is primarily indicated for high-risk myelodysplastic syndrome or acute myeloid leukemia. Cyclophosphamide works by interfering with the DNA replication process in cancer cells, leading to cell death. It is classified as an alkylating agent in pharmacology.
Etoposide
Etoposide is given intravenously and is used in combination with other medications for treating high-risk myelodysplastic syndrome or acute myeloid leukemia. It acts by inhibiting an enzyme called topoisomerase II, which is essential for DNA replication and cell division, thereby causing cancer cell death. Etoposide is classified as a topoisomerase inhibitor.

Investigated diseases

High-Risk Myelodysplastic Syndrome
This condition is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when the bone marrow does not produce enough healthy blood cells, leading to symptoms like fatigue, infections, and easy bruising. Over time, the disease can progress to more severe forms, potentially transforming into acute myeloid leukemia. The progression involves increasing bone marrow failure and worsening blood cell counts. Patients may experience a gradual decline in their overall health due to the lack of functional blood cells. The disease is considered high-risk when there is a greater likelihood of progression to acute leukemia.
Acute Myeloid Leukemia
This is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Symptoms can include fatigue, fever, frequent infections, and bleeding or bruising easily. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression of the disease requires prompt medical attention to manage symptoms and complications.