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)
4 other identifiers
interventional
50
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2014
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedStudy Start
First participant enrolled
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedResults Posted
Study results publicly available
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMay 3, 2023
May 1, 2023
7.6 years
August 15, 2013
March 8, 2022
May 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia
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). The MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicities is \< 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
28 days
Secondary Outcomes (2)
Response Rate (CR+CRi) Among Expansion Cohort
Up to 3 years
Frequency and Severity of Toxicities
Up to 3 years
Study Arms (6)
Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 1
EXPERIMENTALCombination chemotherapy and inotuzumab ozogamicin - Dose level 1 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and 0.4 mg/m2 inotuzumab ozogamicin IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 2
EXPERIMENTALCombination chemotherapy and inotuzumab ozogamicin - Dose level 2 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.6 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 3
EXPERIMENTALCombination chemotherapy and inotuzumab ozogamicin - Dose level 3 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 4
EXPERIMENTALCombination chemotherapy and inotuzumab ozogamicin - Dose level 4 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 5
EXPERIMENTALCombination chemotherapy and inotuzumab ozogamicin - Dose level 5 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment (combination chemotherapy and inotuzumab ozogamicin) - MTD
EXPERIMENTALCombination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given PO
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- Patients must not have received prior treatment with inotuzumab ozogamicin; previous treatment with other anti-CD22 antibodies must have been completed at least 90 days prior to registration
- Patients must have Zubrod performance status 0-2
- Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions:
- Monoclonal antibodies must not have been received for 1 week prior to registration
- Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration.
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
University of Rochester
Rochester, New York, 14642, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SWOG Statistician
- Organization
- SWOG Statistics and Data Management Center
Study Officials
- PRINCIPAL INVESTIGATOR
Anjali Advani
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2013
First Posted
August 19, 2013
Study Start
June 13, 2014
Primary Completion
January 1, 2022
Study Completion
January 1, 2023
Last Updated
May 3, 2023
Results First Posted
April 6, 2022
Record last verified: 2023-05