Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory… (NCT03962465) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL
United States36 participantsStarted 2022-07-22
Plain-language summary
In the proposed study, escalating doses of inotuzumab ozogamicin will be added to a standard pediatric inspired re-induction regimen and administered to patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Two re-induction regimens will be tested (one without pegaspargase and one including pegaspargase) and participants will be followed for disease status, allogeneic hematopoietic cell transplant (allo HCT), veno-occlusive disease following allo HCT, and overall survival.
Who can participate
Age range16 Years – 60 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Diagnosed with CD-22 positive\* B-cell Acute Lymphoblastic Leukemia or B-cell Lymphoblastic Lymphoma (Philadelphia chromosome negative) \* For the purposes of this study, CD-22 positive will be defined based on the analysis completed for diagnostic purposes.
✓. Male or female, aged 16-60 years
✓. ECOG performance status of 0-2
✓. Left ventricular ejection fraction ≥ 50% measured by echocardiogram or MUGA
✓. Either relapsed following remission after initial induction therapy or refractory to induction therapy
✓. Adequate organ function, including serum creatinine ≤ 1.6 mg/dL OR creatinine clearance \>50 ml/min by Cockgroft-Gault formula, bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's disease), AST, ALT and alkaline phosphatase ≤ 3 x upper limit of normal (elevation exceeding this threshold of either AST OR ALT would not meet eligibility)
Exclusion criteria
✕. Past receipt of a total of ≥ 300 mg/m\^2 doxorubicin equivalents (600 mg/m\^2 daunorubicin, 60 mg/m\^2 idarubicin, 75 mg/m\^2 mitoxantrone)
✕. Current or past history of pancreatitis
✕. QT interval on electrocardiogram (ECG) \> 0.45 by Framingham formula
What they're measuring
1
Characterization of Adverse Events (CTCAE version 5)
Timeframe: All adverse events occurring through 30 days following last dose of inotuzumab ozogamicin.
2
Dose-limiting toxicities
Timeframe: From initiation of inotuzumab ozogamicin through 30 days following the last dose of inotuzumab ozogamicin
3
Informative course of treatment
Timeframe: For each participant, up to the 29 days of study treatment