Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

Status unconfirmed · Phase 1

Conditions studied: B-cell Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID: NCT03962465
Run by: University of Virginia
People needed: 36
Starts: 2022-07-22
Expected to finish: 2026-07-01
Last updated by the study team: 2023-08-22

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)
For females of reproductive potential: negative pregnancy test
For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 1 year after the end of study treatment
Agreement to adhere to Lifestyle Considerations throughout study duration and for 1 year following last study treatment.

You may not qualify if…

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
Known congestive heart failure
Known allergy to asparaginase (only an exclusion criteria for participants enrolling in part 2)
Presence of central nervous system (CNS) disease
Pregnancy or lactation
Chronic liver disease including chronic active hepatitis and/or cirrhosis
Active Hepatitis B virus (HBV) by core antibody, surface antigen (HBsAg) or viral load
Active Hepatitis C virus (HCV) (positive antibody test confirmed by viral load if antibody test is positive)
Known history of infection with Human Immunodeficiency Virus (HIV)
Active or uncontrolled infections
Abnormal baseline hepatic ultrasound (including Dopplers)
Prior allogeneic stem cell transplant
Prior use of inotuzumab ozogamicin
Known diagnosis of hemochromatosis with iron overload
Treatment with steroids or hydroxyurea for more than 7 days with each within the 2 weeks prior to registration -that is, each is allowed for up to 7 days
Gastrointestinal tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease, or inability to swallow medications.
Philadelphia chromosome positive B-cell ALL

Where it is running

Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
University of Virginia — Charlottesville, Virginia, United States
VCU Massey Cancer Center — Richmond, Virginia, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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