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Study Comparing Two Drug Combinations for Blood Cancer Patients: Rabbit Anti-Human Thymocyte Immunoglobulin vs. Anhydrous Cyclophosphamide

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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 studying various blood-related cancers, known as hematological malignancies. These include diseases such as Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myeloid Leukemia (CML), Multiple Myeloma, Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin’s Lymphoma, and Hodgkin’s Disease. The study aims to compare two different treatment approaches used before a type of stem cell transplant called allogeneic hematopoietic cell transplantation. The two treatments being compared are called Flu-Mel-PTCy and Flu-Mel-ATG. These treatments are used to prepare the body for the transplant by reducing the intensity of the conditioning regimen, which is the process of getting the body ready to receive new stem cells.

The study involves the use of two medications. The first is Thymoglobuline, which contains an active substance called rabbit anti-human thymocyte immunoglobulin. This medication is given through a drip into a vein, known as an infusion. The second medication is Endoxan, which contains anhydrous cyclophosphamide and is administered as an injection into a vein. The purpose of the study is to determine which of these two treatment approaches is more effective in improving the chances of survival without complications related to the transplant.

Participants in the study will receive one of the two treatment regimens before undergoing the stem cell transplant. The study will monitor the participants over a period of time to assess their health outcomes, including survival rates and any potential side effects. The goal is to find out if one of the treatment methods leads to better results in terms of survival without relapse or severe complications. This information will help doctors make informed decisions about the best treatment options for patients with these types of blood cancers.

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, you will be randomly assigned to one of two treatment groups. This is done to compare two different conditioning regimens before receiving a stem cell transplant.
Step 2
Preparation for treatment
You will undergo a series of tests and evaluations to ensure you are ready for the treatment. This may include blood tests, imaging studies, and other assessments as needed.
Step 3
Conditioning regimen
You will receive a conditioning regimen to prepare your body for the transplant. This involves receiving medications through an intravenous (IV) line.
If you are in the **FM-ATG** group, you will receive **Thymoglobuline** (rabbit anti-human thymocyte immunoglobulin) as a solution for infusion. The dosage and frequency will be determined by the study protocol.
If you are in the **FM-PTCy** group, you will receive **Endoxan** (anhydrous cyclophosphamide) as a solution for injection. The dosage and frequency will be determined by the study protocol.
Step 4
Stem cell transplantation
After completing the conditioning regimen, you will receive the stem cell transplant from a matched donor. This process involves infusing healthy stem cells into your bloodstream through an IV line.
Step 5
Post-transplant monitoring
Following the transplant, you will be closely monitored for any signs of complications or side effects. This includes regular check-ups, blood tests, and other necessary evaluations.
The study aims to assess the **GVHD-free, relapse-free survival** rate, which means monitoring for any signs of graft-versus-host disease (GVHD) and relapse of your condition.
Step 6
Long-term follow-up
You will continue to be followed up for a long period to assess your health and the effectiveness of the treatment. This includes regular visits and assessments as outlined in the study protocol.
The study will evaluate various outcomes, including survival rates and the absence of active disease without the need for systemic immunosuppression over several years.

Who can join the trial?

20 criteria

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The patient must have a confirmed diagnosis of a **hematological malignancy** (a type of blood cancer) such as:
- **AML** (Acute Myeloid Leukemia) in **morphological CR** (complete remission) or not in complete remission but not rapidly progressing.
- **MDS** (Myelodysplastic Syndromes).
- **CML** (Chronic Myeloid Leukemia) in **CP** (chronic phase) or **AP** (accelerated phase).
- **MPD** (Myeloproliferative Disorders) not in blast crisis.
- **MDS/MPD overlap**.
- **ALL** (Acute Lymphoblastic Leukemia) in complete remission.
- **Multiple myeloma**.
- **CLL** (Chronic Lymphocytic Leukemia).
- **Non-Hodgkin’s lymphoma** with chemosensitive disease (responds to chemotherapy).
- **Hodgkin’s disease** with chemosensitive disease or responding to checkpoint inhibitors.
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  The patient must have a theoretical indication for a standard **allo-transplant** (a type of stem cell transplant) but it is not feasible due to:
  - Age over 50 years.
  - Unacceptable end organ performance (organs not functioning well enough).
  - The physician’s decision.
  - The patient’s decision.
  - The patient has an underlying 'lower risk' disease for which **RIC** (Reduced Intensity Conditioning) is preferred, such as **CLL** or **MCL** (Mantle Cell Lymphoma).
  - Continuation of maintenance with **TKI** (Tyrosine Kinase Inhibitors) is allowed after allo-HCT (allogeneic hematopoietic cell transplantation) in case of **Ph+ leukemia** or **FLT-3 mutated AML**.
  - Other maintenance treatments are not allowed unless there is no evidence of relapse or progression of the underlying disease.
  - The patient can be male or female, but fertile patients must use a reliable contraception method.
  - The patient must be between 18 and 75 years old (children of any age are not allowed).
  - The patient must give informed consent, or their guardian must give consent if needed.

Who cannot join the trial?

4 criteria

Patients with rapidly progressing blood cancers that require immediate treatment to control white blood cell counts.
Patients in a blast crisis phase of myeloproliferative disorders, which is a severe stage of the disease.
Patients with aggressive non-Hodgkin's lymphoma that does not respond to chemotherapy.
Patients with Hodgkin's disease that does not respond to checkpoint inhibitors, which are drugs that help the immune system fight cancer.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
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Katholieke Universiteit te Leuven
Leuven, Belgium
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Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Flu
is short for fludarabine, a medication used to suppress the immune system. In this trial, it helps prepare the body for a stem cell transplant by reducing the activity of the immune system, making it less likely to attack the new cells.
Mel
stands for melphalan, a chemotherapy drug that helps destroy cancer cells. It is used in this trial to help eliminate any remaining cancer cells in the body before the transplant, increasing the chances of a successful treatment.
PTCy
refers to post-transplant cyclophosphamide, a medication given after the transplant. It helps prevent the body from rejecting the new stem cells by further suppressing the immune system, reducing the risk of complications.
ATG
stands for anti-thymocyte globulin, a therapy used to lower the immune response. In this trial, it is used to help prevent the body from rejecting the transplanted stem cells, improving the chances of a successful transplant.

What is already known about the treatment

Flu-Mel-PTCy
This medication is administered as part of a conditioning regimen for patients undergoing allogeneic hematopoietic cell transplantation. It is given intravenously, meaning it is delivered directly into the bloodstream through a vein. Currently, it is being studied in clinical trials to determine its effectiveness in improving outcomes for patients with certain blood cancers. The main therapeutic use is to prepare the body for a transplant by suppressing the immune system and reducing the risk of transplant rejection. At the molecular level, it works by interfering with the DNA of rapidly dividing cells, which helps to prevent the growth of cancer cells. It is classified as a chemotherapy agent.
Flu-Mel-ATG
This medication is also used as a conditioning regimen for patients undergoing allogeneic hematopoietic cell transplantation and is administered intravenously. It is being evaluated in clinical trials to assess its potential benefits in improving transplant success rates for patients with specific blood cancers. The primary therapeutic indication is to prepare the patient's body for a transplant by weakening the immune system to minimize the chance of transplant rejection. Its mechanism of action involves targeting and destroying certain immune cells, which helps to prevent the body from attacking the transplanted cells. It is classified as an immunosuppressive agent.

Investigated diseases

Acute Myeloid Leukemia (AML)
This is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal cells, causing symptoms like fatigue, infections, and easy bruising. AML can occur in different subtypes, each with unique characteristics. The disease can be in a state of complete remission (CR) or not in morphological CR but not rapidly progressing.
Myelodysplastic Syndromes (MDS)
These are a group of disorders caused by poorly formed or dysfunctional blood cells. The bone marrow does not produce enough healthy blood cells, leading to symptoms such as anemia, frequent infections, and bleeding. MDS can vary in severity and may progress to acute myeloid leukemia. The disease is characterized by the presence of dysplastic cells in the bone marrow. Over time, the condition can worsen, affecting the production of all types of blood cells.
Chronic Myeloid Leukemia (CML)
This is a cancer of the blood and bone marrow characterized by the overproduction of myeloid cells. It typically progresses through three phases: chronic phase (CP), accelerated phase (AP), and blast crisis. In the chronic phase, symptoms may be mild or absent, but as it progresses, symptoms like fatigue, weight loss, and an enlarged spleen can occur. The disease is associated with a specific genetic abnormality known as the Philadelphia chromosome. CML can remain stable for years before advancing to more aggressive phases.
Myeloproliferative Disorders (MPD)
These are a group of diseases where the bone marrow makes too many red blood cells, white blood cells, or platelets. The condition can lead to symptoms such as fatigue, headaches, and an increased risk of bleeding or clotting. MPD can progress slowly and may transform into acute leukemia. The disease is not in blast crisis, meaning it has not progressed to an aggressive phase. It can overlap with myelodysplastic syndromes, leading to complex clinical presentations.
Acute Lymphoblastic Leukemia (ALL)
This is a cancer of the blood and bone marrow that affects white blood cells called lymphocytes. It progresses rapidly, leading to the accumulation of immature lymphoblasts. Symptoms include fatigue, fever, bleeding, and bone pain. ALL can be in a state of complete remission (CR), where symptoms are reduced or absent. The disease primarily affects children but can also occur in adults.
Multiple Myeloma
This is a cancer of plasma cells, a type of white blood cell found in the bone marrow. It leads to the production of abnormal proteins that can cause kidney problems and weaken bones. Symptoms include bone pain, frequent infections, and anemia. The disease progresses by affecting multiple areas of the body, particularly the bones. Over time, it can lead to significant complications affecting overall health.