NCT03094611

Brief Summary

This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

March 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 12, 2021

Completed
Last Updated

April 12, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

March 20, 2017

Results QC Date

February 1, 2021

Last Update Submit

March 17, 2021

Conditions

CD22 PositiveRecurrent Acute Lymphoblastic LeukemiaRefractory Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants to Achieve Complete Remission (CR)

    Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with \</= 5% blasts with a granulocyte count of 1X10\^9/L or above and a platelet count of \>/= 100X10\^9/L and absence of extramedullary disease.

    Up to 2 years

Secondary Outcomes (4)

  • Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)

    Up to 2 years

  • Duration of Response

    Up to 3 years

  • Progression Free Survival

    Up to 3 years

  • Overall Survival

    Up to 3 years

Study Arms (1)

Treatment (inotuzumab ozogamicin)

EXPERIMENTAL

Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.

Biological: Inotuzumab Ozogamicin

Interventions

Inotuzumab OzogamicinBIOLOGICAL

Given IV

Also known as: Besponsa, CMC-544, Way 207294, WAY-207294
Treatment (inotuzumab ozogamicin)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at least 12 years of age
  • Patients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on local immunophenotyping and histopathology who have:
  • Refractory disease, defined as disease progression or no response while receiving their most recent prior anti-cancer therapy,
  • Relapsed disease, defined as response to their most recent prior anti-cancer therapy with subsequent relapse
  • Performance status of 0 to 3
  • Serum creatinine =\< 2 x upper limit of normal (ULN) or estimated creatinine clearance \>= 15 mL/min as calculated using the method standard for the institution
  • Total serum bilirubin =\< 1.5 x ULN unless the patient has documented Gilbert syndrome. If organ function abnormalities are considered due to tumor, total serum bilirubin must be =\< 2 x ULN
  • Aspartate and alanine aminotransferase (AST or ALT) =\< 2.5 x ULN
  • No active or co-existing malignancy requiring chemotherapy or radiation within 6 months
  • Female subjects of childbearing potential should be willing to use effective methods birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Effective methods of birth control include birth control pills or injections, intrauterine devices (IUDs), or double-barrier methods (for example, a condom in combination with spermicide)
  • Male subjects should agree to use an effective method of contraception starting with the first dose of study therapy through the duration of treatment

You may not qualify if:

  • Pregnant or nursing women
  • Known to be human immunodeficiency virus (HIV)+
  • Philadelphia chromosome (Ph)+ ALL
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Unable or unwilling to sign the consent form
  • Prior allogeneic stem cell transplantation (ASCT) or other anti-CD22 immunotherapy within =\< 4 months before first dose of study treatment
  • Active central nervous system (CNS) or extramedullary disease unless approved by the principal investigator (PI)
  • Monoclonal antibodies therapy within 2 weeks before study entry
  • Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy, hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used emergently in case of leukocytosis) or any investigational drug within 2 weeks before study entry
  • Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

    PMID: 35622074DERIVED

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Elias Jabbour, MD./ Professor, Leukemia
Organization
The University of Texas MD Anderson Cancer Center
ejabbour@mdanderson.org
713-792-4764

Study Officials

  • Elias Jabbour

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 29, 2017

Study Start

November 30, 2017

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

April 12, 2021

Results First Posted

April 12, 2021

Record last verified: 2021-03

Locations

US(1)