Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
June 3, 2026 updated by: University of Chicago
A Phase II Study of a Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia (ALL) Incorporating Inotuzumab Ozogamicin (InO)
This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques).
The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wendy Stock, MD
- Phone Number: 773-834-8982
- Email: PhaseIICRA@medicine.bsd.uchicago
Study Contact Backup
- Name: Cancer Clinical Trials Office
- Phone Number: 1-855-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60615
- Recruiting
- University of Chicago Medical Center
-
Contact:
- Wendy Stock, MD
- Phone Number: 773-834-8982
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Must be a newly diagnosed and untreated patient with Ph+ B-cell Acute Lymphoblastic Leukemia and CD22 expression on ≥20% of blasts.
- 18 years old or older.
- Bone marrow involvement with ≥20% lymphoblasts and demonstration of BCR-ABL1 via fluorescence in situ hybridization (FISH) studies or PCR-based testing. Patients with >1000/mm3 lymphoblasts in the peripheral blood that cannot undergo bone marrow biopsy and aspiration due to clinical condition are also eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function as confirmed by clinical/medical record.
- Patients must be at least 2 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments.
- Patients must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee/Institutional Review Board prior to starting any screening or study-specific procedures.
Females of childbearing potential will use effective contraception during treatment with InO and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during treatment with Inotuzumab Ozogamicin and for at least 5 months after the last dose. A patient is of childbearing potential if, in the opinion of the treating investigator, he/she is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):
a. Have undergone hysterectomy or bilateral oophorectomy; or have medically confirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Isolated extramedullary disease.
- Burkitt's or mixed-lineage leukemia.
- Active central nervous system (CNS) leukemia.
- Any prior therapy for ALL except for limited treatment (≤ 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal therapy. Patients who are being treated with chronic steroids for other reasons (eg, asthma, autoimmune disorders) are eligible.
- Current or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). HIV testing may need to be performed in accordance with local regulations or local practice. Patients with HIV but an undetectable viral load are eligible for enrollment
- Major surgery within ≤ 2 weeks before randomization.
- Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.
- Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.
- Uncontrolled cardiac disease.
- QTcF > 500 msec (based on the average of 3 consecutive ECGs).
- History of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
- History of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
- Evidence of uncontrolled current serious active infection including sepsis, bacteremia, fungemia, or patients with a recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis.
- Medications known to predispose to Torsades de Pointes are prohibited throughout the treatment period of the study.
- Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.
- Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
- Participation in other investigational studies during active treatment phase.
- Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Study Lead Principal Investigator, would make the patient inappropriate for entry into this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Induction/Consolidation Phase - All Participants
All participants in this study will receive the same first round of treatment as part of induction/consolidation therapy. This treatment will use inotuzumab ozogamicin combined with anti-cancer drugs. The additional treatment that participants receive after this first round of treatment will vary based on the participant's response to induction therapy. This phase of treatment will last for 60 days. All participants in this arm will receive the following treatment: Treatment Course I (Induction Phase, 28 days):
Treatment Course II (Consolidation Phase, 28 days):
|
Inotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Other Names:
Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Other Names:
Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
Other Names:
Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Other Names:
|
|
Experimental: Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed)
Participants who no longer show any detectable signs of BCR-ABL1 (a cancer-causing gene) in response to the previous phase of induction/consolidation treatment (also known as being in "complete molecular remission" or CMR). Participants in this arm will receive treatment using dasatinib combined with POMP chemotherapy and intrathecal methotrexate. POMP chemotherapy consists of the drugs 6-Mercaptopurine + Vincristine + Methotrexate + Prednisone. |
Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Other Names:
Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Other Names:
Vincristine, also known as leurocristine and marketed under the brand name Oncovin among others, is a chemotherapy medication used to treat various types of cancer such as acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin's disease, neuroblastoma, and small cell lung cancer among others.
Other Names:
A drug used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia.
It is used in patients whose cancer has the T315I mutation or whose cancer cannot be treated with other tyrosine kinase inhibitors.
It is also being studied in the treatment of other types of cancer.
Ponatinib blocks BCR-ABL, which may help keep cancer cells from growing and may kill them.
Other Names:
Purinethol is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Prednisone is steroid given during chemotherapy treatments.
|
|
Experimental: Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed)
Participants whose cancer responded to induction/consolidation treatment, but still shows detectable signs of BCR-ABL1 (a cancer-causing gene), so they are not in complete molecular remission (CMR). Participants in this arm will receive treatment using ponatinib combined combined with POMP chemotherapy and intrathecal methotrexate. A single 28-day cycle of inotuzumab will be given after initial 84 days of maintenance treatment if CMR has not been achieved. POMP chemotherapy consists of the drugs 6-Mercaptopurine + Vincristine + Methotrexate + Prednisone. |
Inotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Other Names:
Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Other Names:
Vincristine, also known as leurocristine and marketed under the brand name Oncovin among others, is a chemotherapy medication used to treat various types of cancer such as acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin's disease, neuroblastoma, and small cell lung cancer among others.
Other Names:
A drug used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia.
It is used in patients whose cancer has the T315I mutation or whose cancer cannot be treated with other tyrosine kinase inhibitors.
It is also being studied in the treatment of other types of cancer.
Ponatinib blocks BCR-ABL, which may help keep cancer cells from growing and may kill them.
Other Names:
Purinethol is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Prednisone is steroid given during chemotherapy treatments.
|
|
Experimental: Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen )
Participants who no longer show any detectable signs of BCR-ABL1 (a cancer-causing gene) in response to the previous phase of induction/consolidation treatment (also known as being in "complete molecular remission" or CMR).
Participants in this arm will receive treatment using dasatinib and intrathecal methotrexate.
|
Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Other Names:
Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Other Names:
|
|
Experimental: Maintenance Phase - Participants Not in CMR (Schema 3 Regimen)
Participants whose cancer responded to induction/consolidation treatment, but still shows detectable signs of BCR-ABL1 (a cancer-causing gene), so they are not in complete molecular remission. Participants in this arm will receive treatment using ponatinib combined with intrathecal methotrexate. A single 28-day cycle of inotuzumab will be given after initial 84 days of maintenance treatment if CMR has not been achieved. |
Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Other Names:
A drug used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia.
It is used in patients whose cancer has the T315I mutation or whose cancer cannot be treated with other tyrosine kinase inhibitors.
It is also being studied in the treatment of other types of cancer.
Ponatinib blocks BCR-ABL, which may help keep cancer cells from growing and may kill them.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Enter Complete Clinical Remission at 60 Days as Defined by Criteria Set By The International Scale
Time Frame: 60 days
|
Complete clinical remission (when there are no signs of the disease) with a major molecular remission at 60 days as defined by participants who have a low ratio (less than or equal to .01%) of BCR-ABL1gene in their blood, according to criteria set by the International Scale for p210 BCR-ABL1.
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 36 months
|
The length of time from when the participant first receives study treatment to their death (due to any cause) as assessed by the treating investigator.
Participants will be followed for 12 weeks after the last dose of study drug, until any study treatment-related toxicities have stabilized, or until death.
|
36 months
|
|
Duration of Response
Time Frame: 36 months
|
The length of time from the first documented complete response (participant shows no signs of cancer) or partial response (participant shows fewer signs of cancer) to disease progression or death.
Partial/complete response will be assessed by bone marrow biopsies and blood tests.
|
36 months
|
|
Duration of Complete Response
Time Frame: 36 months
|
The length of time from the first documented complete response (when participant shows no signs of cancer) to disease progression or death as assessed by the treating investigator.
|
36 months
|
|
Progression Free Survival
Time Frame: 36 months
|
The time from treatment administration to documented disease progression or death from any cause as assessed by the treating investigator.
|
36 months
|
|
Disease Control Rate Based on Number of Participants Who Respond to Treatment After 3 Months
Time Frame: 36 months
|
The disease control rate based on the number of participants who show a complete response, partial response or no changes in disease (stable disease) after 3 months as assessed by bone marrow biopsies and neutrophil/complete blood count tests.
|
36 months
|
|
Number of Participants with Complete Molecular Remission at 180 Days
Time Frame: 36 months
|
Number of participants with complete molecular remission at 180 days as defined by the absence of a detectable BCR-ABL1 gene, according to criteria set by the International Scale for p210 BCR-ABL1.
Complete molecular remission at 180 days will be assessed among participants who do not undergo allogenic stem cell transplantation after treatment.
|
36 months
|
|
Number of Participants With Documented Veno-Occlusive Disease After Treatment
Time Frame: 36 months
|
The number of patients with documented veno-occlusive disease as assessed by treating investigator.
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wendy Stock, MD, University Of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2021
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 10, 2021
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Hemic and Lymphatic Diseases
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Amino Acids, Peptides, and Proteins
- Proteins
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Thiazoles
- Azoles
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Alkaloids
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Glycosides
- Indoles
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Purines
- Pyrimidines
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Benzene Derivatives
- Sulfonic Acids
- Sulfur Acids
- Pterins
- Pteridines
- Pregnadienetriols
- Pregnadienediols
- Vinca Alkaloids
- Secologanin Tryptamine Alkaloids
- Indole Alkaloids
- Indolizidines
- Indolizines
- Aminopterin
- Aminoglycosides
- Benzenesulfonates
- Arylsulfonates
- Arylsulfonic Acids
- Sulfhydryl Compounds
- Calicheamicins
- Dasatinib
- Inotuzumab Ozogamicin
- Dexamethasone
- Methotrexate
- Prednisone
- Vincristine
- Mercaptopurine
- Calcium Dobesilate
- ponatinib
Other Study ID Numbers
- IRB20-1749
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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