A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia (NCT07313852) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia
United States26 participantsStarted 2026-06
Plain-language summary
The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years of age.
* Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics
* Patients ≥55 years old, OR
* Patients 18-54 years old who decline or are deemed unfit for conventional chemotherapy with at least one of the following criteria:
* ECOG performance status of 2 or more
* Severe cardiac comorbidity (including congestive heart failure requiring treatment)
* Known pulmonary comorbidity (including DLCO ≤65% or FEV1 ≤65%)
* Renal comorbidity (including creatinine clearance 30-45 mL/min)
* Relapsed or refractory CD19+ and CD22+ B-ALL
* Patients with extramedullary disease will be allowed as long as they have detectable disease by flow cytometry in the bone marrow
* Peripheral absolute lymphoblast count of ≤ 10,000/ml after pre-phase (not required for enrollment but required to proceed with first dose of inotuzumab).
* Philadelphia chromosome negative by FISH/karyotype for t(19;22) or RT PCR for bcr-abl transcript.
* CD19 and CD22 expression will be confirmed by enrolling institutions prior to study registration by flow cytometry and/or IHC.
* Creatinine clearance ≥30 mL/min
* Total bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤3.0x upper limit of normal (ULN)
* QTcF ≤ 480
* Ejection fraction ≥ 50%
Exclusion Criteria:
* Patients with Burkitt's lymphoma, T-ALL, CML in lymphoid blast crisis and mixed phenotype acute leukemia (MPAL).
* Patients with newly diagnosed B-ALL who received prior treatments, with the exceptio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines two drugs — inotuzumab and blinatumomab — rather than using them one at a time; can you help me understand why combining them might matter for my specific situation, and whether there's any existing safety data on using these two drugs together?
2Since this is a Phase 1/Phase 2 trial that hasn't started enrolling yet, what does that mean for what's known — or not yet known — about the safety and the right dose of this combination, and how should that uncertainty factor into my decision?
3The Phase 1 part of this study is specifically focused on finding the maximum tolerated dose, which means dose-related side effects are actively being studied; what kinds of side effects are already associated with inotuzumab and blinatumomab individually, and how might those risks be amplified when the two are combined?
4The trial is measuring whether patients reach MRD-negative complete remission after induction — can you explain what MRD-negative means in plain terms, and how achieving or not achieving that milestone might affect my longer-term treatment path?
5Since this trial is not yet recruiting, is there a standard treatment approach or an already-open study I should be considering right now while I wait to see if this one becomes available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I: Maximum Tolerated Dose/MTD
Timeframe: up to 1 year
2
Phase II: Rate of MRD negative CR/CRi (10-4 threshold) at the end of induction.