Refractory Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia
Verified date | March 2021 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | March 11, 2020 |
Est. primary completion date | March 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Up to 2 years | |
Secondary | Duration of Response | The date of Complete Response to the date of loss of response or last follow-up. | Up to 3 years | |
Secondary | Progression Free Survival | Time from date of treatment start until the date of first objective documentation of disease-relapse. | Up to 3 years | |
Secondary | Overall Survival | Time from date of treatment start until date of death due to any cause or last Follow-up. | Up to 3 years |
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