- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094611
Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia
Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants to Achieve Complete Remission (CR)
Time Frame: Up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)
Time Frame: Up to 2 years
|
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
|
Duration of Response
Time Frame: Up to 3 years
|
The date of Complete Response to the date of loss of response or last follow-up.
|
Up to 3 years
|
Progression Free Survival
Time Frame: Up to 3 years
|
Time from date of treatment start until the date of first objective documentation of disease-relapse.
|
Up to 3 years
|
Overall Survival
Time Frame: Up to 3 years
|
Time from date of treatment start until date of death due to any cause or last Follow-up.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Inotuzumab Ozogamicin
Other Study ID Numbers
- 2015-0870 (OTHER: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2018-01237 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Acute Lymphoblastic Leukemia
-
Children's Oncology GroupNational Cancer Institute (NCI); ImmunoGen, Inc.WithdrawnRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Recurrent Mixed Phenotype Acute Leukemia | Refractory Mixed Phenotype Acute Leukemia | Refractory T Acute Lymphoblastic Leukemia | Recurrent...
-
National Cancer Institute (NCI)CompletedRecurrent Adult Lymphoblastic Lymphoma | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | B-cell Adult Acute Lymphoblastic Leukemia | B-cell Childhood Acute Lymphoblastic Leukemia | T-cell Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
M.D. Anderson Cancer CenterRecruitingRecurrent Adult Lymphoblastic Lymphoma | Recurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Refractory T Acute Lymphoblastic Leukemia | Recurrent T Acute Lymphoblastic Leukemia | Refractory Lymphoblastic LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Refractory T Acute Lymphoblastic Leukemia | Recurrent T Acute Lymphoblastic LeukemiaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedAdult Acute Lymphoblastic Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia in Remission | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
ECOG-ACRIN Cancer Research GroupRecruitingRecurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | Refractory Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | Lymphoblasts 5 Percent or More of Bone Marrow Nucleated CellsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent Acute Lymphoblastic Leukemia | Refractory Acute Lymphoblastic LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingPreviously Treated Myelodysplastic Syndrome | Recurrent Adult Acute Myeloid Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Acute Myeloid Leukemia in Remission | Adult Acute Lymphoblastic... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)WithdrawnRecurrent Adult Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | Recurrent B Lymphoblastic Lymphoma | Refractory B Lymphoblastic Lymphoma | B Lymphoblastic Lymphoma | Recurrent T Lymphoblastic Leukemia/Lymphoma | Refractory T Lymphoblastic Lymphoma | T Acute Lymphoblastic Leukemia | T...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent Acute Lymphoblastic Leukemia | Refractory Acute Lymphoblastic Leukemia | Refractory Acute Leukemia of Ambiguous Lineage | Recurrent Acute Leukemia of Ambiguous LineageUnited States
Clinical Trials on Inotuzumab Ozogamicin
-
PfizerUCB PharmaCompletedLymphomaUnited States, Belgium, Japan, Korea, Republic of, Germany, Hong Kong, Hungary, Netherlands, Singapore
-
Nicola GoekbugetRecruitingPrecursor Cell Lymphoblastic LeukemiaGermany
-
Gruppo Italiano Malattie EMatologiche dell'AdultoRecruitingAcute Lymphoid LeukemiaItaly
-
PfizerCompletedLymphoma, B-CellUnited States, Spain, France, Switzerland, United Kingdom, Belgium, Germany
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Novartis PharmaceuticalsWithdrawn
-
PfizerCompletedLeukemia | Precursor b-Cell Lymphoblastic Leukemia-Lymphoma | ACUTE LYMPHOBLASTIC LEUKEMIAUnited States, Spain, Taiwan, Singapore, India, Hungary, Turkey, Poland
-
Institute of Hematology & Blood Diseases HospitalNot yet recruiting
-
PfizerActive, not recruiting
-
Versailles HospitalActive, not recruitingAcute Lymphoblastic Leukemia (ALL) - Philadelphia Chromosome (Ph)-Negative CD22+ B-cell Precursor (BCP)France