Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL (ALL-001)

  • End date
    Aug 30, 2028
  • participants needed
  • sponsor
    University of Virginia
Updated on 18 June 2022
philadelphia chromosome
flow cytometry
ejection fraction
gilbert's syndrome
prednisone pill


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.


Inotuzumab ozogamicin has been studied as a single agent in refractory and relapsed ALL. In the relapsed setting, inotuzumab ozogamicin has been shown to achieve complete remission (CR) in 81% of patients and minimal residual disease (MRD) negativity in 78% of patients who achieve CR. 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 ALL. Two re-induction regimens will be tested. The first regimen is a 3-drug regimen comprised of prednisone, vincristine, and daunorubicin. The second is a 4-drug regimen comprised of prednisone, vincristine, daunorubicin, and pegaspargase. Intrathecal methotrexate (IT-methotrexate) and intrathecal cytarabine (IT-ARA-C) will be included for central nervous system (CNS) prophylaxis with both the 3-drug and 4-drug regimens. We hypothesize that combining inotuzumab ozogamicin with these regimens is safe and will improve CR rates, successful transition to allo HCT, and overall survival in patients with relapsed or refractory B-ALL.

Condition B-cell Acute Lymphoblastic Leukemia
Treatment methotrexate, cytarabine, vincristine, Pegaspargase, Daunorubicin, Inotuzumab Ozogamicin, Prednisone Pill
Clinical Study IdentifierNCT03962465
SponsorUniversity of Virginia
Last Modified on18 June 2022


Yes No Not Sure

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)
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

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
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
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
Known diagnosis of hemochromatosis with iron overload
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
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