Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
NCT03913559
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
866-278-5833
Age
- Participants must be < 22 years of age.
Diagnosis
- Participants must have B-ALL with persistent or rising MRD between 0.1 and 4.99% without extramedullary disease following at least two prior induction attempts, relapse or after hematopoietic stem cell transplant
- Leukemia blasts demonstrating surface expression of CD22
Performance Level
- Karnofsky or Lansky performance score ≥ 50% (corresponding to ECOG Score of ≥ 2). The Lansky performance score should be used for participants < 16 years and the Karnofsky performance score for participants ≥ 16 years.
Prior Therapy
- Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion/exclusion criteria prior to entering this study.
- At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroids.
- At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur.
- At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab. Patients must have been off blinatumomab infusion for at least 7 days and all drug related toxicity must have resolved to Grade 2 or lower as outlined in the inclusion/exclusion criteria.
- At least 42 days must have elapsed since CAR-T cell therapy.
- Participant has received ≤ 1 prior bone marrow transplant.
- At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for ≥ 2 weeks, if applicable with no evidence of active GVHD.
- At least 2 weeks must have elapsed since local XRT (small port); ≥ 3 months must have elapsed if prior cranial or craniospinal XRT was received, if ≥ 50% of the pelvis was irradiated, or if TBI was received; ≥ 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
Organ Function Requirements
- Adequate renal function defined as glomerular filtration rate ≥ 60 cc/min/1.73m2 or serum creatinine based on age as follows:
- Age: <6 months; maximum serum creatinine (mg/dL): 0.4 (male, female); Age: 6 months to <1 year; maximum serum creatinine (mg/dL): 0.5 (male, female); Age: 1 to < 2 years; maximum serum creatinine (mg/dL): 0.6 (male, female); Age: 2 to < 6 years; maximum serum creatinine (mg/dL): 0.8 (male, female); Age: 6 to <10 years; maximum serum creatinine (mg/ dL): 1 (male, female); Age: 10 to <13 years; maximum serum creatinine (mg/dL): 1.2 (male, female); Age: 13 to <16 years; maximum serum creatinine (mg/dL): 1.5 (male), 1.4 (female); Age: ≥ 16 years; maximum serum creatinine (mg/dL): 1.7 (male), 1.4 (female)
- Adequate hepatic function defined as:
- Direct bilirubin ≤ 1.4 mg/dL (if total bilirubin > 1.4 mg/dL) and
- AST or ALT ≤ 3 x ULN for age.
- Adequate cardiac function defined as shortening fraction of ≥ 27% or ejection fraction ≥ 45%.
- History of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of any
severity.
- Concurrent chemotherapy or targeted anti-cancer agents, other than intrathecal
therapy.
- Patient with concurrent severe and/or uncontrolled medical conditions that, in the
opinion of the investigator, may impair participation in the study or the evaluation
of safety and/or efficacy.
- Known HIV infection or active hepatitis B (defined as hepatitis B surface
antigen-positive) or C (defined as hepatitis C antibody-positive).
- Pregnant or lactating (female participant of childbearing potential must have negative
serum or urine pregnancy test required within 7 days prior to start of treatment).
- Male or female participant of reproductive potential must agree to use appropriate
methods of contraception for the duration of study treatment and for at least 30 days
after last dose of protocol treatment.
- Inability or unwillingness of research participant or legal guardian/representative to
give written informed consent.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Memphis, Tennessee
- Houston, Texas
- Brussels,
- Brussels,
- Brussels,
- Edegem,
- Ghent,
- Leuven,
- Leuven,
- Liège,
- Liège,
- Aalborg,
- Aarhus,
- Aarhus,
- Copenhagen,
- Copenhagen,
- Odense,
- Tallinn,
- Tallinn,
- Tartu,
- Tartu,
- Helsinki,
- Helsinki,
- Kuopio,
- Kuopio,
- Oulu,
- Oulu,
- Tampere,
- Tampere,
- Turku,
- Turku,
- Bielefeld,
- Bonn,
- Bremen,
- Hamburg,
- Krefeld,
- Mainz,
- München,
- Reykjavík,
- Dublin,
- Vilnius,
- Utrecht,
- Bergen,
- Bergen,
- Oslo,
- Oslo,
- Stavanger,
- Tromsø,
- Tromsø,
- Trondheim,
- Trondheim,
- Coimbra,
- Lisboa,
- Porto,
- Gothenburg,
- Gothenburg,
- Linköping,
- Linköping,
- Lund,
- Lund,
- Stockholm,
- Stockholm,
- Umeå,
- Umeå,
- Uppsala,
- Uppsala,
- Örebro,
- Aberdeen,
- Aberdeen,
- Belfast,
- Belfast,
- Birmingham,
- Birmingham,
- Bristol,
- Cambridge,
- Cardiff,
- Cardiff,
- Dundee,
- Edinburgh,
- Edinburgh,
- Glasgow,
- Glasgow,
- Leeds,
- Leeds,
- Leicester,
- Liverpool,
- Liverpool,
- London,
- London,
- Manchester,
- Manchester,
- Newcastle,
- Newcastle,
- Nottingham,
- Nottingham,
- Oxford,
- Oxford,
- Plymouth,
- Sheffield,
- Sheffield,
- Southampton,
- Stoke,
- Sutton,
- La Jolla, California
- La Jolla, California
- La Jolla, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Orange, California
- Orange, California
- Orange, California
- Palo Alto, California
- San Diego, California
- Stanford, California
- Stanford, California
- Stanford, California
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- New Haven, Connecticut
- Miami, Florida
- Orlando, Florida
- Orlando, Florida
- Orlando, Florida
- Orlando, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Augusta, Georgia
- Augusta, Georgia
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Iowa City, Iowa
- Kansas City, Kansas
- Westwood, Kansas
- Louisville, Kentucky
- Louisville, Kentucky
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- Farmington Hills, Michigan
- Hackensack, New Jersey
- Hackensack, New Jersey
- New Brunswick, New Jersey
- Albuquerque, New Mexico
- Albuquerque, New Mexico
- Lake Success, New York
- Manhasset, New York
- New York, New York
- New York, New York
- New York, New York
- Rochester, New York
- Stony Brook, New York
- Stony Brook, New York
- Stony Brook, New York
- Stony Brook, New York
- Chapel Hill, North Carolina
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Hershey, Pennsylvania
- Hershey, Pennsylvania
- Charleston, South Carolina
- Charleston, South Carolina
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Houston, Texas
- Salt Lake City, Utah
- Seattle, Washington
- Seattle, Washington
- Morgantown, West Virginia
- Morgantown, West Virginia
- Cordoba,
- Adelaide, South Australia
- Box Hill, Victoria
- Toronto, Ontario
- Guangzhou, Guangdong
- Zhengzhou, Henan
- Changchun, Jilin
- Beijing,
- Beijing,
- Beijing,
- Tianjin,
- Brno,
- Hradec Kralove,
- Praha 10,
- Helsinki,
- Helsinki,
- Dijon,
- Grenoble Cedex 09,
- Le Chesnay Cedex,
- Limoges Cedex,
- Marseille,
- Paris Cedex 10,
- Pierre Benite Cedex,
- Saint Priest en Jarez Cedex,
- Toulouse Cedex 9,
- Vandoeuvre-les-Nancy,
- Muenster, Nordrhein-westfalen
- Frankfurt,
- Heidelberg,
- Köln,
- Muenchen,
- Muenster,
- Muenster,
- Budapest,
- Debrecen,
- Cagliari, CA
- Cagliari, CA
- Cagliari, CA
- Meldola (FC), FC
- Bologna,
- Catania,
- Catania,
- Cona, Ferrara,
- Genova,
- Genova,
- Genova,
- Genova,
- Genova,
- Milano,
- Milano,
- Milano,
- Monza,
- Monza,
- Napoli,
- Napoli,
- Pavia,
- Ravenna,
- Ravenna,
- Ravenna,
- Udine,
- Udine,
- Nagoya, Aichi
- Nishinomiya-shi, Hyogo
- Sendai, Miyagi
- Osaka-city, Osaka
- Chuo-ku, Tokyo
- Akita,
- Fukuoka,
- Kanagawa,
- Hwasun-Gun, Jeonnam
- Seoul,
- Seoul,
- Rotterdam, South Holland
- Rotterdam, South Holland
- Gdansk,
- Lodz,
- Warsaw,
- Wroclaw,
- Singapore,
- Singapore,
- Badalona, Barcelona
- Salamanca, Castille AND LION
- Barcelona, Catalonia
- Palma de Mallorca, Mallorca
- Barcelona,
- Madrid,
- Madrid,
- Madrid,
- Murcia,
- Sevilla,
- Valencia,
- Lund,
- Stockholm,
- Kaohsiung,
- Taipei,
- Southampton, Hampshire
- Bristol,
- Hull,
- London,
- Manchester,
- Nottingham,
- Oxford,
Descriptive Information | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia | ||||||||||||||
Official Title ICMJE | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia | ||||||||||||||
Brief Summary | This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL). Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are needed to achieve undetectable MRD in these high-risk patients. Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4 monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic. CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional activity in adults with relapsed or refractory B-ALL. Primary Objective
Secondary Objectives
| ||||||||||||||
Detailed Description | The drug will be administered intravenously on days 1, 8, and 15 of each 28-day cycle. Patients who do not meet the definition of treatment failure after the first cycle may receive up to five additional cycles of therapy. . After completion of study treatment, patients are followed for 1 year. | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||
Condition ICMJE | Acute Lymphoblastic Leukemia | ||||||||||||||
Intervention ICMJE |
| ||||||||||||||
Study Arms ICMJE | Experimental: Inotuzumab ozogamicin
Experimental:Inotuzumab Ozogamicin (InO) Patients with B cell acute lymphoblastic leukemia (B-ALL) that is showing early signs of relapsing (coming back) or is not responding to treatment (refractory). Interventions:methotrexate, hydrocortisone and cytarabine into the central nervous system (called triple intrathecal chemotherapy or IT chemotherapy) during this study. Premedication: diphenhydramine, acetaminophen and methylprednisolone Interventions:
| ||||||||||||||
Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||
Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE | 32 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | January 2024 | ||||||||||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Age
Diagnosis
Performance Level
Prior Therapy
Organ Function Requirements
Exclusion Criteria:
| ||||||||||||||
Sex/Gender ICMJE |
| ||||||||||||||
Ages ICMJE | up to 21 Years (Child, Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
| ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03913559 | ||||||||||||||
Other Study ID Numbers ICMJE | INOMRD NCI-2019-01062 ( Registry Identifier: NCI Clinical Trial Registration Program ) | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product |
| ||||||||||||||
IPD Sharing Statement ICMJE |
| ||||||||||||||
Responsible Party | St. Jude Children's Research Hospital | ||||||||||||||
Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||||||||||||
Collaborators ICMJE | Pfizer | ||||||||||||||
Investigators ICMJE |
| ||||||||||||||
PRS Account | St. Jude Children's Research Hospital | ||||||||||||||
Verification Date | June 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |