Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Inotuzumab ozogamicin
DrugInotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Dasatinib
DrugDasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Dexamethasone
DrugDexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
Methotrexate
DrugMethotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Vincristine
DrugVincristine, 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.
Ponatinib
DrugA 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)
DrugPurinethol is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
Prednisone
DrugPrednisone is steroid given during chemotherapy treatments.
Treatment groups
25 Participants
are divided into 5 treatment groupsGroup A: Induction/Consolidation Phase - All ParticipantsExperimental treatment 4 interventions
Group B: Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed)Experimental treatment 6 interventions
Group C: Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed)Experimental treatment 6 interventions
Group D: Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen )Experimental treatment 2 interventions
Group E: Maintenance Phase - Participants Not in CMR (Schema 3 Regimen)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
60 daysSecondary outcomes
1
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.
Time frame
36 months2
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.
Time frame
36 months3
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.
Time frame
36 months4
Progression Free Survival
The time from treatment administration to documented disease progression or death from any cause as assessed by the treating investigator.
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov