Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
2015-0870
- SECONDARY ID:
NCI-2018-01237
- SECONDARY ID:
2015-0870
- SECONDARY ID:
P30CA016672
- NCT ID:
NCT03094611
Conditions
- CD22 Positive
- Recurrent Acute Lymphoblastic Leukemia
- Refractory Acute Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
Inotuzumab Ozogamicin | Besponsa, CMC-544, Way 207294, WAY-207294 | Treatment (inotuzumab ozogamicin) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate of low dose of inotuzumab ozogamicin |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | Measured by the hematologic remission rate (complete remission [CR] + CR with incomplete platelet recovery + CR with incomplete bone marrow recovery [CRi]) in patients in first, second or later salvage setting. |
Secondary Outcome Measures
Measure: | Incidence of adverse events |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | |
Measure: | Hematologic response rate (CR + CRi + partial response) |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | |
Measure: | Duration of remission |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | |
Measure: | Progression free survival |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Up to 6 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
April 2, 2020