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

Primary Purpose

CD22 Positive, Recurrent Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Inotuzumab Ozogamicin

About this trial

This is an interventional treatment trial for CD22 Positive

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (inotuzumab ozogamicin)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.

Duration of Response

The date of Complete Response to the date of loss of response or last follow-up.

Progression Free Survival

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up.

Full Information

NCT ID

NCT03094611

First Posted

March 20, 2017

Last Updated

March 17, 2021

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03094611

Brief Title

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

Official Title

Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

the study was closed early due to competing trials

Study Start Date

November 30, 2017 (Actual)

Primary Completion Date

March 11, 2020 (Actual)

Study Completion Date

March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CD22 Positive, Recurrent Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (inotuzumab ozogamicin)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Inotuzumab Ozogamicin

Other Intervention Name(s)

Besponsa, CMC-544, Way 207294, WAY-207294

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Number of Participants to Achieve Complete Remission (CR)

Description

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 2 years

Title

Duration of Response

Description

The date of Complete Response to the date of loss of response or last follow-up.

Time Frame

Up to 3 years

Title

Progression Free Survival

Description

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Time Frame

Up to 3 years

Title

Overall Survival

Description

Time from date of treatment start until date of death due to any cause or last Follow-up.

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elias Jabbour

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35622074

Citation

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.

Results Reference

derived

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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