Study of Inotuzumab Ozogamicin and drug combination in adult patients with B-cell Acute Lymphoblastic Leukemia who have minimal residual disease before stem cell transplantation

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What is this study about?

This study focuses on adults with B-cell Acute Lymphoblastic Leukemia, a rare type of blood cancer that affects cells that develop into white blood cells. The study specifically looks at patients who have minimal residual disease (small numbers of cancer cells that remain after treatment) before receiving a hematopoietic stem cell transplantation (a procedure that replaces blood-forming cells).

The main treatment being studied is Inotuzumab Ozogamicin (also known as Besponsa), which will be given through an intravenous infusion. Additional medications that may be used in the treatment include Cyclophosphamide, Methotrexate, Prednisone, Ponatinib, Vincristine, and Mercaptopurine. The purpose of the study is to determine how well Inotuzumab Ozogamicin works in eliminating remaining cancer cells in patients.

The treatment period may last up to two years, during which patients will receive the study medication through regular infusions. Throughout the study, doctors will monitor the presence of cancer cells and track how patients respond to the treatment. They will also watch for any side effects that may occur during or after the treatment.

1 Initial evaluation

Your bone marrow will be examined to confirm that blast cells are less than 5% and that you are in complete remission

Laboratory tests will check your liver function through bilirubin, ALT, and AST levels

Your pancreatic function will be evaluated through lipase and amylase tests

2 Treatment course 1

You will receive Inotuzumab ozogamicin (Besponsa) through intravenous infusion

Your response to treatment will be monitored through blood tests and bone marrow examination

Your minimal residual disease (MRD) levels will be measured after the first course

3 Treatment course 2

A second course of Inotuzumab ozogamicin may be administered if needed

Your MRD levels will be measured again after the second course

Regular monitoring of liver and pancreatic function will continue

4 Additional medications

You may receive additional medications as part of your treatment:

Cyclophosphamide – given through intravenous infusion

Methotrexate – given through intravenous infusion

Prednisone – taken by mouth

Ponatinib – taken by mouth

Vincristine – given through intravenous infusion

Mercaptopurine – taken by mouth

5 Follow-up period

Your health status will be monitored for up to 2 years after treatment

Regular checks will be performed to detect any side effects or complications

Your disease status will be evaluated through blood tests and examinations

Who Can Join the Study?

Must be 18 years or older with no upper age limit
Must have been diagnosed with B-cell Lymphoblastic Leukemia with more than 20% of cancer cells (blasts) in bone marrow at diagnosis
Must have cancer cells that are CD22 positive (a specific marker on the surface of cancer cells)
Must be in first or second complete remission with less than 5% cancer cells in bone marrow
Must have a life expectancy of more than 12 weeks
Must have normal liver function, specifically:
- Normal bilirubin levels (unless due to Gilbert’s syndrome)
- Normal levels of liver enzymes (ALT and AST)
Must have normal pancreas function, with normal levels of lipase and amylase enzymes
For women who can become pregnant, must have a negative pregnancy test during screening
Both men and women who can have children must use effective contraception during the study and for 4 months after treatment ends
Women who are breastfeeding must stop during treatment and should not restart after treatment
Men must agree not to donate sperm during treatment and for 12 months after the last dose
Must provide written informed consent to participate in the study

Who Cannot Join the Study?

History of prior treatment with Inotuzumab ozogamicin (a type of targeted cancer therapy)
Active central nervous system involvement of leukemia (cancer cells present in brain or spinal cord)
Significant heart conditions, including:
- Heart failure (when heart cannot pump blood effectively)
- Recent heart attack (within past 6 months)
- Unstable heart rhythm disorders
Severe liver problems or active liver disease
Active uncontrolled infections
Known HIV infection
Active hepatitis B or C infection
Pregnancy or breastfeeding
Unable to provide informed consent
Current participation in other clinical trials
Major surgery within 4 weeks before starting the study
Any condition that, in the opinion of the study doctor, would make participation unsafe
History of other cancers within the past 3 years (except for successfully treated skin cancer or cervical cancer in situ)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Ospedale dell’Angelo di Mestre	Mestre – Venezia	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Central Hospital Of Bolzano	Bolzano	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno	Ascoli Piceno	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Ospedale S. Eugenio, ASL Roma 2	Rome	Italy
Amukssp Olzxiqchlzz Omjjlcmc Rffdxlo Vkray Stlyl Cexmumkk	Palermo	Italy
Iylwfrpw Rebqflmih Poq Lx Sqalnh Dzy Tppurm Dzne Awrtkov Iwqe Ssjqnf	Meldola	Italy
Abynzjy Oftqfotwgxd Uvpxkpdvhvtos Syztsa	Siena	Italy
Arohioj Ofjzqrkcfvd Usuokcpcfrlhr Csxmwvjqbodm Dcfgu Stmfpq E Duzrp Srojajd Dl Tiwulz	Turin	Italy
Andsiyy Oeymbubokwk Nijtucfcx Sy Audgfwq E Behgyl E C Awpqec Atmsbmcxmhb	Alexandria	Italy
Aypuysm Obyiyxgiudb Umfgcvquwvkuj Ompfaucg Rjccble	Foggia	Italy
Aqnuegh Uncux Sqbpffubi Leuieo Dd Bjakwkg	Bologna	Italy
Awaksgt Oqlmlzvavtn Pszm Gvgkzrvb Xogvz	Bergamo	Italy
Uiudzwstvh Dujgk Ssccu Dv Rigk Ln Suzqjuzi	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	30.10.2019

Trial locations

Investigated drugs:

Inotuzumab ozogamicin is a targeted cancer medication used to treat B-cell acute lymphoblastic leukemia (ALL). It works by attaching to cancer cells that have a specific protein called CD22 on their surface, and then delivers a substance that kills these cancer cells. This medication is given through an intravenous (IV) infusion and is specifically used when there are small amounts of cancer cells remaining in the body (minimal residual disease) before a stem cell transplant procedure.

Acute B-cell Lymphoblastic Leukemia – A blood and bone marrow cancer that affects B-lymphocytes, a type of white blood cell. The disease develops when immature B-cells (called lymphoblasts) multiply uncontrollably in the bone marrow, preventing the production of normal blood cells. These abnormal cells quickly build up and spread to other parts of the body through the bloodstream. The condition progresses rapidly over a few weeks, affecting the body’s ability to fight infections and maintain normal blood cell counts. In some cases, small numbers of cancer cells can remain in the body even after initial treatment, which is known as minimal residual disease.

Trial ID:

2023-510516-39-00

Protocol code:

ALL2418

NCT ID:

NCT03610438

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Inotuzumab Ozogamicin and drug combination in adult patients with B-cell Acute Lymphoblastic Leukemia who have minimal residual disease before stem cell transplantation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?