Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukemia

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What is this study about?

This study focuses on older adults with a newly diagnosed type of cancer called B-cell precursor Acute Lymphoblastic Leukemia. Specifically, the study looks at patients who are Philadelphia-negative, which means their cancer cells do not have a specific genetic marker. The purpose of the study is to compare a new treatment approach to the current standard of care to see how well it works and how safe it is.

Participants may receive different combinations of medications. One group will receive blinatumomab alternating with low-intensity chemotherapy, which is a type of treatment that uses drugs to kill cancer cells. The other group will receive the standard of care, which includes medications such as rituximab, cytarabine, dexamethasone, vincristine sulfate, cyclophosphamide, methotrexate sodium, mercaptopurine, prednisone, idarubicin, asparaginase, and doxorubicin. Other substances mentioned in the study include pegaspargase, crisantaspase, and prednisolone.

The study will monitor how long patients live and how long they stay without the cancer returning. Researchers will also look at the minimal residual disease, which refers to the small number of cancer cells that remain in the body after treatment. Additionally, the study will track how the treatments affect the patients’ quality of life, including levels of pain, tiredness, and physical function.

Who Can Join the Study?

You must give informed consent, which means you or your legal representative agrees to take part in the study after understanding all the details, before any study steps begin.
You must be 55 years of age or older.
You may be between 40 and 54 years of age if you have certain comorbidities, which are other medical conditions present at the same time as your leukemia, such as:
- A history of severe pancreatitis (inflammation of the pancreas).
- Diabetes mellitus that has caused damage to organs like the eyes, kidneys, or nerves.
- Severe liver disease, such as cirrhosis (permanent scarring of the liver) with high pressure in the veins or a history of bleeding in the food pipe, accompanied by very high liver enzyme levels.
- A body mass index (BMI) of 40 or higher combined with metabolic issues.
- Other serious health conditions that make standard intensive chemotherapy too difficult to handle.
You must have a new diagnosis of Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL), which is a specific type of cancer found in the white blood cells.
Your ECOG performance status must be 2 or lower, which is a scale used to measure how well you can perform daily activities; a higher score may be allowed if it is caused by your leukemia.
Your kidney function must be adequate, measured by how well your kidneys filter waste from your blood.
Your liver function must be adequate, specifically looking at your total bilirubin levels, unless you have a specific harmless condition called Gilbert’s Disease or the cancer has spread to the liver.
Your heart function must be adequate, meaning your heart must pump blood effectively (measured by left ventricular ejection fraction) and you must not have uncontrolled or recent heart disease, such as a myocardial infarction (heart attack) or stroke within the last 3 months.

Who Cannot Join the Study?

You cannot participate if you have active CNS leukemia, which means cancer cells are currently present in your central nervous system (the brain and spinal cord), as confirmed by a lumbar puncture (a procedure where a needle is used to collect fluid from the spinal canal).
You cannot participate if you have had another type of malignancy (cancer) within the last 3 years, unless it was a specific type of skin, cervical, breast, or prostate cancer that was fully treated and is no longer active.
You cannot participate if you have CNS pathology, which refers to any medical conditions or damage affecting the brain or spinal cord, such as epilepsy (seizures), paresis (muscle weakness), aphasia (difficulty speaking or understanding language), stroke, dementia (memory loss and mental decline), or Parkinson’s disease.
You cannot participate if you have a psychiatric condition (mental health disorder) that would prevent you from taking high doses of corticosteroids (strong anti-inflammatory medicines).
You cannot participate if you currently have or have a history of autoimmune disease (a condition where the immune system mistakenly attacks the body) that could affect the brain or spinal cord.
You cannot participate if you have a known infection with HIV (the virus that causes AIDS).
You cannot participate if you have an active or chronic infection of Hepatitis B or Hepatitis C (viruses that cause liver inflammation).
You cannot participate if you show any signs or symptoms of an acute infection (a sudden, severe infection) or an uncontrolled chronic infection (a long-term infection that is not being managed).
You cannot participate if you have already received cancer chemotherapy (drugs used to kill cancer cells) for this specific leukemia, unless it was IT chemotherapy (medicine injected directly into the spinal fluid) or specific preparation medicine.
You cannot participate if you are currently taking part in another study testing a new drug or medical device, or if you finished a different study less than 30 days ago.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert	Belgium
Evangelismos S.A.	Athens	Greece
Institut Jules Bordet	Anderlecht	Belgium
General University Hospital Of Larissa	Larissa	Greece
University Of Debrecen	Debrecen	Hungary
Laiko General Hospital Of Athens	Athens	Greece
Institut Paoli-Calmettes Cancer Centre	Marseille	France
Hospital Vall d’Hebron	Barcelona	Spain
Institutul Regional De Oncologie Iasi	Iasi	Romania
North Estonia Medical Centre Foundation	Tallin	Estonia
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Odense University Hospital	Odense	Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Helsinki University Central Hospital	Helsinki	Finland
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Turku University Hospital	Turku	Finland
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Spitalul Universitar De Urgenta Bucuresti	Bucharest	Romania
Hospital Universitario De Salamanca	Salamanca	Spain
Centro Hospitalar E Universitario De Coimbra E.P.E.	Coimbra	Portugal
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino	Turin	Italy
Aalborg University Hospital	Aalborg	Denmark
Jessa Ziekenhuis	Hasselt	Belgium
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
CHRU De Nancy	Vandoeuvre Les Nancy	France
General University Hospital Of Patras	Patras	Greece
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Lille	Lille	France
University Of Szeged	Szeged	Hungary
Centre Hospitalier Universitaire De Rennes	Rennes	France
Rigshospitalet	Copenhagen	Denmark
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Medizinische Universitaet Innsbruck	Innsbruck	Austria
University Of Antwerp	Edegem	Belgium
Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	Italy
Oncopole Claudius Regaud	Toulouse	France
Universita Degli Studi Di Roma La Sapienza	Rome	Italy
Ordensklinikum Linz GmbH	Linz	Austria
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Universitair Medisch Centrum Groningen	Groningen	The Netherlands
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Marques De Valdecilla	Santander	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Institut Catala D’oncologia	L'hospitalet De Llobregat	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
University General Hospital Of Heraklion	Heraklion	Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Hopital Saint Antoine	Paris	France
Centre Hospitalier Universitaire De Dijon	Dijon	France
Assistance Publique Hopitaux De Paris	Paris	France
Tartu University Hospital	Tartu	Estonia
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Narodny Onkologicky Ustav	Bratislava	Slovakia
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Hospital Santa Maria Della Misericordia	Perugia	Italy
University Hospital Bratislava	Bratislava	Slovakia
Grand Hopital De Charleroi	Charleroi	Belgium
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Semmelweis University	Budapest	Hungary
Centre Hospitalier Universitaire De Nice	Nice	France
Medical University Of Graz	Graz	Austria
Region Midtjylland	Aarhus	Denmark
Hopital Beaujon	Clichy	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden

Other Sites

Site Name	City	Country
Fundeni Clinical Institute	Bucharest	Romania
Ustav Hematologie A krevni Transfuze	Prague	Czechia
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Cabinet Medical Van Houte Cornejo Montero	Yvoir	Belgium
Azienda Ulss 3 Serenissima	Venice	Italy
University Hospital Consorziale Policlinico	Bari	Italy
Usgbwaowsh Gdeafux Hanhskbn Oh Iihmipch	Ioannina	Greece
Omzqpapj Vppg Frmgt Lzkym	Lecce	Italy
Spfvpnpd Cmdegs Msauyqwik Fqgmydnqctz Cbbhiia	Craiova	Romania
Scrvbret Cyzoiz Jilurkvh Ds Ucxvdvf Socip	Sibiu	Romania

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	03.11.2021
Belgium	Not recruiting	03.11.2021
Bulgaria	Not recruiting	03.11.2021
Czechia	Not recruiting	03.11.2021
Denmark	Not recruiting	03.11.2021
Estonia	Not recruiting	03.11.2021
Finland	Not recruiting	03.11.2021
France	Not recruiting	03.11.2021
Greece	Not recruiting	03.11.2021
Hungary	Not recruiting	03.11.2021
Italy	Not recruiting	03.11.2021
Portugal	Not recruiting	03.11.2021
Romania	Not recruiting	03.11.2021
Slovakia	Recruiting	03.11.2021
Spain	Not recruiting	03.11.2021
Sweden	Not recruiting	03.11.2021
The Netherlands	Not recruiting	03.11.2021

Trial locations

Investigated Drugs:

Blinatumomab is a type of immunotherapy that helps the body’s own immune system find and destroy specific cancer cells.

Mercaptopurine is a chemotherapy medication used to prevent the growth of cancer cells.

Rituximab is a targeted therapy that attaches to certain proteins on the surface of cancer cells to help the immune system identify and attack them.

Cytarabine is a chemotherapy drug used to treat various types of blood cancers by preventing cancer cells from making new DNA.

Methotrexate is a chemotherapy medication that interferes with the growth of cancer cells by blocking certain nutrients they need to multiply.

Cyclophosphamide is a chemotherapy drug used to kill rapidly dividing cancer cells.

Dexamethasone is a steroid medication used to reduce inflammation and sometimes to help kill certain types of cancer cells.

Idarubicin is a chemotherapy medication used to treat leukemia by interfering with the DNA of cancer cells.

Prednisone is a steroid medication used to reduce swelling and inflammation in the body.

Pegaspargase is a therapy used to treat certain leukemias by depriving cancer cells of a specific nutrient they need to survive.

Doxorubicin is a chemotherapy drug used to treat several types of cancer, including leukemia, by damaging the DNA of cancer cells.

Vincristine is a chemotherapy medication that stops cancer cells from dividing properly.

Asparaginase is a therapy used to treat leukemia by reducing the amount of a specific amino acid that cancer cells require to grow.

Crisantaspase is a type of enzyme therapy used to treat certain blood cancers by targeting the nutrients cancer cells need to survive.

Investigated Diseases:

Acute lymphocytic leukaemia

B-cell precursor Acute Lymphoblastic Leukemia – This is a type of cancer that affects the white blood cells, specifically the immature cells known as precursors. These abnormal cells accumulate in the bone marrow and blood, interfering with the production of normal blood cells. The disease can progress by spreading from the bone marrow to other parts of the body, such as the lymph nodes, spleen, or liver. It is characterized by the rapid multiplication of these cancerous cells.

Trial ID:

2023-503640-14-00

Protocol code:

20190360

NCT ID:

NCT04994717

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?