Lymphoblastic LeukemiaPhase 2NCT04747912
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
A Phase 2 study testing Inotuzumab ozogamicin, Dasatinib and Dexamethasone in people with Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, run by University of Chicago at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, ph+ Acute Lymphoblastic Leukemia
- What is being tested?
- Inotuzumab ozogamicin, Dasatinib and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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):
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60615
Wendy Stock, MD, 773-834-8982, cancerclinicaltrials@bsd.uchicago.edu
About this study
Official title: 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.
- Being tested
- Inotuzumab ozogamicin, Dasatinib, Dexamethasone, Methotrexate, Vincristine
- Keywords
- leukemia, Acute Lymphoblastic Leukemia, ph+ Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inotuzumab ozogamicinDrug
Also called Besponsa
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.
DasatinibDrug
Also called SPRYCEL
Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
DexamethasoneDrug
Also called Decadron®, Dexamethasone Intensol®, Dexasone, Solurex®, and Baycadron®
Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
MethotrexateDrug
Also called Otrexup™, Rasuvo®, Rheumatrex® and Trexall™. MTX, Amethopterin, and Methotrexate Sodium
Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
VincristineDrug
Also called Oncovin and Vincasar Pfs
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.
PonatinibDrug
Also called Iclusig
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.
Purinethol (6-Mercaptopurine)Drug
Purinethol is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
PrednisoneDrug
Prednisone is steroid given during chemotherapy treatments.
| Study group | Role | What they receive |
|---|---|---|
| Induction/Consolidation Phase - All Participants | Experimental | 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):
* Dasatinib 140mg daily continuous
* Dexamethasone 10mg/m^2 PO or IV Days 1-7 and Day 15-Day 22
* InO 0.8mg/m2 Day 8; 0.5mg/m2 D15, 0.5mg/m2 Day 22
* Intrathecal methotrexate 15mg Day 1, Day 28
Treatment Course II (Consolidation Phase, 28 days):
* Dasatinib 140mg daily continuous
* InO: If in CR/CRi 0.5mg/m2 Day 1, Day 8, Day 15; If not in CR/CRi 0.8mg/m2 on Day 1, 0.5mg/m2 Day 8 and Day 15
* Intrathecal methotrexate 15mg Day 1, Day 28 Receives: Drug: Inotuzumab ozogamicin; Drug: Dasatinib; Drug: Dexamethasone; Drug: Methotrexate |
| Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) | Experimental | 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. Receives: Drug: Dasatinib; Drug: Methotrexate; Drug: Vincristine; Drug: Ponatinib; Drug: Purinethol (6-Mercaptopurine); Drug: Prednisone |
| Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed) | Experimental | 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. Receives: Drug: Inotuzumab ozogamicin; Drug: Methotrexate; Drug: Vincristine; Drug: Ponatinib; Drug: Purinethol (6-Mercaptopurine); Drug: Prednisone |
| Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen ) | Experimental | 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. Receives: Drug: Dasatinib; Drug: Methotrexate |
| Maintenance Phase - Participants Not in CMR (Schema 3 Regimen) | Experimental | 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. Receives: Drug: Methotrexate; Drug: Ponatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Enter Complete Clinical Remission at 60 Days as Defined by Criteria Set By The International Scale
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.
Measured: 60 days
Secondary outcomes (7)
Overall Survival
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.
Measured: 36 months
Duration of Response
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.
Measured: 36 months
Duration of Complete Response
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.
Measured: 36 months
Progression Free Survival
The time from treatment administration to documented disease progression or death from any cause as assessed by the treating investigator.
Measured: 36 months
Disease Control Rate Based on Number of Participants Who Respond to Treatment After 3 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.
Measured: 36 months
Number of Participants with Complete Molecular Remission at 180 Days
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.
Measured: 36 months
Number of Participants With Documented Veno-Occlusive Disease After Treatment
The number of patients with documented veno-occlusive disease as assessed by treating investigator.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start2 Mar 2021
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Stock, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747912
- Sponsor's protocol ID
- IRB20-1749
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of a Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia (ALL) Incorporating Inotuzumab Ozogamicin (InO)
- ClinicalTrials.gov ID
- NCT04747912
- Acronym / sponsor ID
- IRB20-1749
- Keywords
- leukemia, Acute Lymphoblastic Leukemia, ph+ Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Induction/Consolidation Phase - All Participants | Experimental | Drug: Inotuzumab ozogamicin, Drug: Dasatinib, Drug: Dexamethasone, Drug: MethotrexateAll 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): * Dasatinib 140mg daily continuous * Dexamethasone 10mg/m^2 PO or IV Days 1-7 and Day 15-Day 22 * InO 0.8mg/m2 Day 8; 0.5mg/m2 D15, 0.5mg/m2 Day 22 * Intrathecal methotrexate 15mg Day 1, Day 28 Treatment Course II (Consolidation Phase, 28 days): * Dasatinib 140mg daily continuous * InO: If in CR/CRi 0.5mg/m2 Day 1, Day 8, Day 15; If not in CR/CRi 0.8mg/m2 on Day 1, 0.5mg/m2 Day 8 and Day 15 * Intrathecal methotrexate 15mg Day 1, Day 28 |
| Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) | Experimental | Drug: Dasatinib, Drug: Methotrexate, Drug: Vincristine, Drug: Ponatinib, Drug: Purinethol (6-Mercaptopurine), Drug: PrednisoneParticipants 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. |
| Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed) | Experimental | Drug: Inotuzumab ozogamicin, Drug: Methotrexate, Drug: Vincristine, Drug: Ponatinib, Drug: Purinethol (6-Mercaptopurine), Drug: PrednisoneParticipants 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. |
| Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen ) | Experimental | Drug: Dasatinib, Drug: MethotrexateParticipants 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. |
| Maintenance Phase - Participants Not in CMR (Schema 3 Regimen) | Experimental | Drug: Methotrexate, Drug: PonatinibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inotuzumab ozogamicinAlso: BesponsaInotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia. | Drug | Induction/Consolidation Phase - All Participants, Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed) |
| DasatinibAlso: SPRYCELDasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). | Drug | Induction/Consolidation Phase - All Participants, Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen ), Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) |
| DexamethasoneAlso: Decadron®, Dexamethasone Intensol®, Dexasone, Solurex®, and Baycadron®Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation. | Drug | Induction/Consolidation Phase - All Participants |
| MethotrexateAlso: Otrexup™, Rasuvo®, Rheumatrex® and Trexall™. MTX, Amethopterin, and Methotrexate SodiumMethotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia. | Drug | Induction/Consolidation Phase - All Participants, Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen ), Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed), Maintenance Phase - Participants Not in CMR (Schema 3 Regimen), Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) |
| VincristineAlso: Oncovin and Vincasar PfsVincristine, 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. | Drug | Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed), Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) |
| PonatinibAlso: IclusigA 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. | Drug | Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed), Maintenance Phase - Participants Not in CMR (Schema 3 Regimen), Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) |
| Purinethol (6-Mercaptopurine)Purinethol is a chemotherapy drug that is used to treat certain types of cancer and leukemia. | Drug | Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed), Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) |
| PrednisonePrednisone is steroid given during chemotherapy treatments. | Drug | Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed), Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed) |
Primary outcome
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.
7 secondary outcomes
Overall Survival
Time frame: 36 months
Duration of Response
Time frame: 36 months
Duration of Complete Response
Time frame: 36 months
Progression Free Survival
Time frame: 36 months
Disease Control Rate Based on Number of Participants Who Respond to Treatment After 3 Months
Time frame: 36 months
Number of Participants with Complete Molecular Remission at 180 Days
Time frame: 36 months
Number of Participants With Documented Veno-Occlusive Disease After Treatment
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Stock, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inotuzumab ozogamicin, Dasatinib and Dexamethasone in people with Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Clinical Trials Office (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Enter Complete Clinical Remission at 60 Days as Defined by Criteria Set By The International Scale (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.