Study of three different doses of busulfan with fludarabine and thymoglobuline in stem cell transplantation for patients with high-risk myeloid blood disorders

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What is this study about?

This study focuses on patients with high-risk myeloid malignancies, which are serious blood disorders affecting bone marrow function. The research evaluates different treatment approaches for patients who will undergo stem cell transplantation from matched donors. The treatment combines three medications: Busulfan (given in different doses through intravenous infusion), Fludarabine, and Thymoglobuline.

The main purpose of this research is to determine how well patients respond to different doses of Busulfan when combined with the other medications as preparation therapy before stem cell transplantation. This preparation therapy, also known as conditioning therapy, helps prepare the body to receive the donor’s stem cells.

During the study, patients will receive these medications through intravenous infusion. Busulfan will be given at different dose levels, while Fludarabine and Thymoglobuline will be administered at set doses. After receiving these medications, patients will undergo the stem cell transplantation procedure. The study will monitor how patients respond to the treatment over time, particularly focusing on whether the disease returns or progresses.

1 Initial treatment preparation

You will receive a combination of three medications through intravenous infusion (directly into your vein) as preparation for stem cell transplantation

This treatment is designed for patients with blood-related conditions that require stem cell transplantation from a matched donor

2 Medication administration

The treatment involves three main medications:

– Busulfan (given as an infusion into your vein)

– Thymoglobuline (given as an infusion into your vein)

– Fludarabine (given as an infusion into your vein)

3 Stem cell transplantation

After the preparation treatment, you will receive stem cells from your matched donor

The donor may be a family member or an unrelated person who matches your tissue type

4 Recovery monitoring

Your blood cell counts will be monitored until they reach normal levels:

– White blood cells should reach 500 cells

– Platelets should reach 50,000 (without need for transfusions)

Your progress will be checked at 1 month, 2 months, and 3 months after transplantation

5 Long-term follow-up

Your condition will be monitored for up to 2 years to track your progress

Regular check-ups will assess how well the treatment is working

Any side effects will be recorded and managed according to standard medical guidelines

Who Can Join the Study?

Patients with poor prognosis blood disorders, specifically:
- Myelodysplastic syndrome (a condition where blood cells don’t develop properly)
- Acute Myeloid Leukemia (AML) in specific situations:
  - Beyond first complete remission, regardless of genetic features
  - After receiving two rounds of initial treatment
  - With no favorable risk factors according to established medical criteria
Patients must be either:
- Between 50 and 65 years old
- Under 50 years old but not suitable for stronger treatment methods involving radiation or combined chemotherapy
Must have a matching donor who is either:
- A sibling with matching tissue type (HLA identical)
- An unrelated donor with complete tissue match (10/10 match)
Must have valid social security coverage
Must provide written informed consent to participate in the study

Who Cannot Join the Study?

Patients who have active, uncontrolled infections
Patients with severe heart problems or ejection fraction (heart’s pumping ability) less than 40%
Patients with severe lung problems or diffusion capacity (ability to transfer oxygen) less than 50%
Patients with severe kidney problems or creatinine clearance (kidney function test) less than 50 ml/min
Patients with severe liver problems
Pregnant or breastfeeding women
Patients who are unable to provide informed consent
Patients with active psychiatric conditions that could interfere with treatment compliance
Patients with HIV infection (human immunodeficiency virus)
Patients with active hepatitis B or C infection
Patients who have participated in another clinical trial within the past 30 days
Patients with known allergies to study medications
Patients with uncontrolled high blood pressure
Patients who have had previous stem cell transplantation
Patients with other active cancers requiring treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
CHU d’Estaing	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Saint Eloi	Montpellier	France
Htbxioo ljdxrvqifbzggh 1	Nice	France
Ilqvfcgj dx Cohghfbbvnda Hdkcxvuykxy Uxcrpkechzmvq dr Sgrcs Eslwzot (afdncgy	Saint Priest En Jarez	France
Axcsghtqdp Prirtoeb Hqxijgwz Dn Pxukd	Paris	France
Bjfrwhnq Uklflubhec Hfjxovak Ckpvel	Besançon	France
Cidk Du Nqgyp	Vandoeuvre Les Nancy	France
Ciqzek Hzimfvfdwei Rijesxag Dkvulcthcevqay	Angers	France
Ivkkusxc Ptvfltluwezmaaa Cmbrjc Cxkcyk	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	17.03.2014

Trial locations

Investigated drugs:

Busulfan (intravenous) is a chemotherapy medication used in stem cell transplantation. It helps prepare the body for transplantation by suppressing the immune system and making space in the bone marrow for new cells.

Fludarabine is a chemotherapy drug that works by interfering with the growth of cancer cells and suppressing the immune system. It is commonly used in combination with other medications before stem cell transplantation.

Thymoglobuline (also known as anti-thymocyte globulin) is an immune-suppressing medication that helps prevent rejection after transplantation. It works by reducing the activity of certain immune cells in the body.

These medications are used together as a conditioning treatment before stem cell transplantation in patients with blood disorders affecting the myeloid cells (a type of blood cell).

Myeloid Malignancies – A group of blood and bone marrow disorders where abnormal blood cells develop from myeloid stem cells. These conditions affect the production and function of blood cells, including red blood cells, white blood cells, and platelets. The disease progresses when abnormal cells multiply and crowd out healthy blood cells in the bone marrow. This condition can develop gradually or rapidly, depending on the specific type of myeloid malignancy. Over time, the bone marrow’s ability to produce normal blood cells becomes increasingly impaired.

Graft Versus Host Disease (GVHD) – A condition that occurs after receiving cells from a donor, where the transplanted cells recognize the recipient’s body as foreign. The condition can affect various organs and tissues, including the skin, liver, and digestive tract. GVHD can develop within weeks of transplantation (acute) or months later (chronic). The condition causes various symptoms depending on which organs are affected.

Trial ID:

2024-516435-27-00

NCT ID:

NCT01985061

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of three different doses of busulfan with fludarabine and thymoglobuline in stem cell transplantation for patients with high-risk myeloid blood disorders

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?