BridgeMD
Trial aimed at examinate the functionality and effectiveness of the drug "IO" in adult patients with a rare form of cancer that affect the cells from which the white blood cells (cells present in the blood) originate before being subjected to a medical procedure used in hematology known as transplantation, which leads to the replacement of the cells from which the blood originates.
EU CTIS ID: 2023-510516-39-00
What this study is testing
The primary objective of the study is to determine effectiveness of Inotuzumab in obtaining MRD negativity in MRD positive ALL patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- To be classified as having ALL according to WHO classification of haematological neoplasms, patients must have >20% blasts in bone marrow at the time of diagnosis
- For females of childbearing potential, a negative pregnancy test must be documented at Screening
- Female and male patients who are fertile should use an effective form of contraception with their sexual partners from screening through 4 months after the end of treatment. As a precautionary measure, breast-feeding should be discontinued during treatment with Inotuzumab and should not be restarted after discontinuation of Inotuzumab. Male patients must agree to refrain from sperm donation, from initial treatment administration until 12 months after the last dose of study drug
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Blasts at the diagnosis or in any timepoint had to be CD22+
- To have a measurable BCR-ABL1 fusion transcript (cohort 1) or a measurable IG/TCR specific rearrangement (cohort 2)
You likely can't join if
- More than 5% of BM blasts
- Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
- Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day
- Documented inherited protrombotic disorders
- Patients who have received any investigational drug = 4 weeks
- Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy;
See the full eligibility criteria
Who can join
- To be classified as having ALL according to WHO classification of haematological neoplasms, patients must have >20% blasts in bone marrow at the time of diagnosis
- For females of childbearing potential, a negative pregnancy test must be documented at Screening
- Female and male patients who are fertile should use an effective form of contraception with their sexual partners from screening through 4 months after the end of treatment. As a precautionary measure, breast-feeding should be discontinued during treatment with Inotuzumab and should not be restarted after discontinuation of Inotuzumab. Male patients must agree to refrain from sperm donation, from initial treatment administration until 12 months after the last dose of study drug
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Blasts at the diagnosis or in any timepoint had to be CD22+
- To have a measurable BCR-ABL1 fusion transcript (cohort 1) or a measurable IG/TCR specific rearrangement (cohort 2)
- To have any measurable MRD positivity after at least: a. 3 months of therapy for Ph+ ALL, or the failure of at least 2nd line TKI (cohort 1) b. 2 courses of therapy for Ph- ALL (cohort 2)
- and to not have more than 5% of bone marrow blasts. Patients has to be in 1st or 2nd complete remission.
- Patients = 18 years old with no upper age limit
- Patients with a life expectancy >12 weeks
- Adequate hepatic function as defined by the following criteria: a. total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome b. alanine aminotransferase (ALT) =2.5 × ULN c. aspartate aminotransferase (AST) =2.5 × ULN
- Adequate pancreatic function as defined by the following criterion: a. serum lipase and amylase =1.5 × ULN
What rules you out
- More than 5% of BM blasts
- Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
- Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day
- Documented inherited protrombotic disorders
- Patients who have received any investigational drug = 4 weeks
- Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy;
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention or with a life expectancy due to other malignancy <6 months
- Patients that have received Inotuzumab or Anti CD22 directed therapies before
- Patients with known hereditary coagulopathy
- Patient that received during their life diagnosis of VOD or had ongoing VOD
- Patients with hypersensitivity to the active substance or to any of the excipients (Sucrose, Polysorbate 80, Sodium chloride, tromethamine)
- WHO performance status = 50% (Karnofsky) or = 3 (ECOG)
- Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs. Fertile patients will be advised to adopt contraceptive methods while on treatment
- Patients unwilling or unable to comply with the protocol
- Active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN
- Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography
- History of alcohol abuse
- Burkitt lymphoma and active CNS leukemia. Patients with previuos neurological toxicitiy as well comorbidity will be carefully evaluated for enrolment
- Ongoing or active infections
- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
- Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: a. any history of myocardial infarction, stroke, or revascularization b. unstable angina or transient ischemic attack within 6 months prior to enrollment c. congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment d. history of clinically significant (as determined by the treating physician) atrial arrhythmia e. any history of ventricular arrhythmia f. any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.