Study on MaaT033 to Prevent Complications in Patients with Blood Cancer Undergoing Stem Cell Transplantation

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What is this study about?

This clinical trial is focused on patients with hematologic malignancies, which are types of blood cancers. These patients are undergoing a procedure called allogeneic hematopoietic cell transplantation (alloHCT), a treatment that involves replacing diseased bone marrow with healthy cells from a donor. The study is testing a new treatment called MaaT033, which is an oral medication in the form of a prolonged-release capsule. MaaT033 contains a special mixture known as allogeneic fecal microbiota, which is designed to help prevent complications that can occur after the transplantation.

The purpose of the study is to compare the effectiveness of MaaT033 with a placebo in improving overall survival rates at 12 months after the treatment begins. Participants in the study will be randomly assigned to receive either MaaT033 or a placebo, which is a capsule that looks like the treatment but does not contain the active substance. The study is conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results.

Throughout the study, participants will take the medication orally, and their health will be monitored over a period of time to assess the treatment’s impact on their survival and any potential side effects. The study aims to provide valuable information on whether MaaT033 can effectively prevent complications in patients undergoing alloHCT, potentially leading to better outcomes for those with blood cancers.

1 joining the trial

Upon joining the trial, you will be randomly assigned to receive either the MaaT033 treatment or a placebo. The placebo is a capsule that looks like the treatment but does not contain the active substance.

2 medication administration

You will take the assigned capsule orally. The capsule is a prolonged-release form, which means it releases the substance slowly over time.

The dosage, frequency, and duration of administration will be provided by the medical team overseeing the trial.

3 monitoring and follow-up

Throughout the trial, your health will be closely monitored. This includes regular check-ups and assessments to track your overall health and any changes that may occur.

The main goal is to evaluate the effectiveness of the treatment in preventing complications related to your condition.

4 completion of the trial

The trial aims to assess the overall survival rate at 12 months after you start the treatment. This means your progress will be followed for at least one year.

At the end of the trial, the results will be analyzed to determine the success of the treatment compared to the placebo.

Who Can Join the Study?

  • Patients must be 50 years or older.
  • Must have a hematologic malignancy (a type of blood cancer) for which a specific type of transplant called alloHCT is needed. This transplant should use a treatment plan that is less intense or has reduced side effects.
  • Patients must have polynuclear neutrophils (a type of white blood cell) greater than 0.5 G/L.
  • Must have taken wide spectrum antibiotics (medications that treat a variety of infections) within the last 90 days before joining the study.
  • Must have a Karnofsky index of 70% or higher. This is a score that measures a patient’s ability to perform everyday activities.
  • Must have a suitable donor available, which can be a sibling, an unrelated stem-cell donor, or a familial haploidentical donor (a partially matched family member).
  • Must provide written informed consent, meaning they agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

  • Patients who are not undergoing allogenic hematopoietic cell transplantation. This is a type of procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who do not have hematologic malignancies. These are types of cancer that affect the blood, bone marrow, or lymph nodes.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Centre Hospitalier Universitaire De Nice Nice France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitario Virgen De Las Nieves Granada Spain
Hopital Saint Antoine Paris France
Virgen del Rocío University Hospital Sevilla Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Saarland University Hospital Homburg Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Cwyqshrkd Uvnzqbvvwjkuyw Sxrkhbscs Woluwe-Saint-Lambert Belgium
Aiugcikhrl Plkowwde Himaagux Dn Pvnpu Paris France
Uyjtiwvkgwdz Mfbfqdj Cpasqml Gkslqhima Groningen The Netherlands
Hodgietb Urkpklfdtlpzd Mzmdzao Dr Vaiyverkwd Santander Spain
Ivdzhrca Ctknzj Dctylwalkjgqcsexc L'hospitalet De Llobregat Spain
Ckvchh Hzugzunlwtx El Uacywrschfepo Du Lqivmmj Limoges France
Bigyywlo Usuozvhiyo Hfperdvo Ctuesq Besançon France
Epvsgzd Ufbplwqcjjdl Myiztzt Chsgbad Rdlcvadfn (fmkukon Mhs Rotterdam The Netherlands
Ccxmkn Hmpnztspicz Rtmuzggj Ubiodhclksnre Dq Tgqea Tours France
Gexqix Utffprwrkz Fzycaahno Frankfurt Germany
Ugyemscfftdfatgkivjzk Wzlpbjohm Axl Wuerzburg Germany
Hhwpfgpq Dh Lz Sfozo Cwxw I Snrd Pbk Barcelona Spain
Uycugtgxgh Ov Agewguj Edegem Belgium
Uuwndeeujnvhisktkjsss Eobrr Aop Essen Germany
Umecmuepefteogxjqirmh Aqtmytom Augsburg Germany
Ckkudh Hbzcyuvmiso Rikrvdbz Dyncxademednie Angers France
Fnydopdrg Peqp Lv Iyitkqdeoixsi Brjjquhvv Dpo Hxicprsj Uwoczvgfenegr Lm Pad Madrid Spain
Ilcpwhfp ds Ceqnayntagxi Hbuupxtmtur Uoyobtsvtdxer dc Surma Efkoqps (zihlsny Saint Priest En Jarez France
Hoxnlxed Vtxf dprnegdm Barcelona Spain
Izusbzud Puasyljiqxtutpp Csvcxl Cgefqv Marseille France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.01.2023
France France
Recruiting
01.01.2023
Germany Germany
Recruiting
01.01.2023
Spain Spain
Recruiting
01.01.2023
The Netherlands The Netherlands
Recruiting
01.01.2023

Trial locations

MaaT033 is an oral treatment that uses a mixture of healthy bacteria from the gut, known as fecal microbiotherapy. This therapy aims to restore the natural balance of bacteria in the intestines. In this clinical trial, MaaT033 is being tested to see if it can help prevent complications that might occur after a type of stem cell transplant called allogeneic hematopoietic cell transplantation. The goal is to improve the chances of survival for patients by maintaining a healthy gut environment.

Hematologic Malignancies – Hematologic malignancies are cancers that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system. These diseases include various types of leukemia, lymphoma, and myeloma. They typically involve the uncontrolled growth of abnormal blood cells, which can interfere with the production and function of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. The progression can vary significantly depending on the specific type of hematologic malignancy. Over time, these conditions can affect the body’s ability to fight infections, carry oxygen, and control bleeding.

Trial ID:
2022-501831-18-00
Protocol code:
MPOH08
Trial Phase:
Therapeutic exploratory (Phase II)

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