Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia

NCT ID: NCT03094611

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2020-03-11

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate of low dose of inotuzumab ozogamicin as measured by the hematologic remission rate (complete remission [CR] + CR with incomplete platelet recovery [CRp] + CR with incomplete bone marrow recovery [CRi]) in patients in first, second or later salvage setting.

SECONDARY OBJECTIVES:

I. To evaluate the overall safety profile and the efficacy; the efficacy is measured by the hematologic response rate (CR + CRi + PR), durations of response (DoR) and remission (DoR1), progression free survival (PFS), and overall survival (OS).

OUTLINE:

Patients receive inotuzumab ozogamicin intravenously (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.

Conditions

CD22 Positive; Recurrent Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (inotuzumab ozogamicin)

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.

Group Type: EXPERIMENTAL

Inotuzumab Ozogamicin

Intervention Type: BIOLOGICAL

Given IV

Interventions

Inotuzumab Ozogamicin

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

Besponsa; CMC-544; Way 207294; WAY-207294

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elias Jabbour

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35622074 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2018-01237

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0870

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0870

Identifier Type: -

Identifier Source: org_study_id