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 range18 Years – 55 Years
SexALL
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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…
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.