A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years of age.
Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics
Patients ≥55 years old, OR
ECOG performance status of 2 or more
Disqualifiers
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 exception of corticosteroid, hydroxyurea, or one dose of vincristine, are ineligible.
Patients with Ph+ B-ALL by FISH or RT PCR.
ECOG performance status >3.
Trial design
Design model
Single group
Treatments tested in this trial
Blinatumomab Injection
DrugBlinatumomab given via subcutaneous injection
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Phase I: Participants With Newly Diagnosed B-cell Acute Lymphoblastic LeukemiaExperimental treatment 1 intervention
Group B: Phase II: Participants With Newly Diagnosed B-cell Acute Lymphoblastic LeukemiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase I: Maximum Tolerated Dose/MTD
To establish the MTD in phase 1 part of the study
Time frame
up to 1 year2
Phase II: Rate of MRD negative CR/CRi (10-4 threshold) at the end of induction.
To evaluate the efficacy of concurrent inotuzumab at the RP2D and subcutaneous blinatumomab in participants as assessed by rate of MRD negative CR/CRi (10-4 threshold) at the end of induction.
Time frame
up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: