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S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia

S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's Leukemia)

NCT01925131•SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the safety of inotuzumab ozogamicin in combination with cyclophosphamide, vincristine (vincristine sulfate) and prednisone (CVP) and to determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia \[B-ALL\], mixed phenotype, and Burkitt's). SECONDARY OBJECTIVES: I. To estimate the preliminary activity (response rate: complete remission \[CR\] + complete remission with incomplete count recovery \[CRi\]) of this combination in the expansion cohort. II. To estimate the frequency and severity of toxicities of this combination in this patient population. OUTLINE: This is a dose-escalation study of inotuzumab ozogamicin. Patients receive cyclophosphamide intravenously (IV) on day 1, vincristine sulfate IV on day 1, prednisone orally (PO) on days 1-5, and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitt's leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded
•Patients must have evidence of acute leukemia in their peripheral blood or bone marrow; patients must have \>= 5% blasts in the peripheral blood or bone marrow within 14 days prior to registration; at least \>= 20% of those blasts must be CD22-positive (surface) based on local immunophenotyping and histopathology
•Patients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabine
•For sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following criteria:
•* Patient is in second salvage or more; OR
•* Patient was treated on the standard of care arm of B1931022 and failed therapy
•Patients may have received prior allogeneic transplant or autologous transplant; however, patients with prior allogeneic bone marrow transplant will be eligible only if both of the following conditions are met:
•* The transplant must have been performed \>= 90 days prior to registration
•* The patient must not have \>= grade 2 acute graft versus host disease (GvHD) or either moderate or severe limited chronic GvHD within 14 days prior to registration
•Patients known to have Philadelphia chromosome positive (Ph+) ALL must have either failed treatment or been intolerant to treatment with at least two second or third generation tyrosine kinase inhibitors
+15 more criteria

Exclusion Criteria

•Patients must not have a history of chronic or active hepatitis B or C infection; patients must have negative hepatitis B and C serologies performed within 28 days prior to registration
•Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome
•Patients must not have a cardiac ejection fraction \< 45% or the presence of New York Heart Association stage III or IV heart failure within 14 days prior to registration; either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) may be used to determine ejection fraction
•Patients must not have a myocardial infarction within 6 months prior to registration
•Patients must not have a history of clinically significant arrhythmia, prolonged corrected QT (QTc) interval, or unexplained syncope not thought to be vasovagal in nature within 6 months prior to registration
•Patients must not have a screening corrected QT using Fridericia's formula (QTcF) interval \> 500 milliseconds (by Fridericia calculation) based on the average of triplicate electrocardiogram (EKG) performed within 7 days prior to registration; note that triplicate EKG is required at other timepoints
•Patients must not have a history of chronic liver disease (or cirrhosis)
•Patients who are known to be human immunodeficiency virus (HIV)+ are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
•* CD4+ cells \>= 350/mm\^3 (nadir)
•* Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or \< 25,000 copies HIV mRNA if not on cART
+8 more criteria

Locations (5)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

University of Rochester

Rochester, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ben Taub General Hospital

Houston, Texas, United States

Key Dates

Start Date

June 13, 2014

Primary Completion Date

January 1, 2022

Completion Date

January 1, 2023

Last Updated

May 3, 2023

Enrollment

ACTUAL participants

Conditions

Acute Leukemias of Ambiguous LineageB-cell Adult Acute Lymphoblastic LeukemiaPhiladelphia Chromosome Positive Adult Precursor Acute Lymphoblastic LeukemiaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Burkitt Lymphoma

Interventions

cyclophosphamide

DRUG

vincristine sulfate

DRUG

prednisone

DRUG

inotuzumab ozogamicin

BIOLOGICAL

laboratory biomarker analysis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia

Inclusion Criteria

Exclusion Criteria

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