Clinical trial · Interventional
Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): the study was closed early due to competing trials
Summary
Brief summary (as posted)
This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia in Remission | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| B Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Inotuzumab Ozogamicin | Biological | Inotuzumab Ozogamicin | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Leucovorin Calcium | Drug | Leucovorin | ALIAS |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hyper-CVAD, inotuzumab ozogamicin)
- description
- See detailed description.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Dexamethasone
- Drug: Doxorubicin Hydrochloride
- Biological: Inotuzumab Ozogamicin
- Other: Laboratory Biomarker Analysis
- Drug: Leucovorin Calcium
- Drug: Mercaptopurine
- Drug: Methotrexate
- Biological: Ofatumumab
- Drug: Prednisone
- Biological: Rituximab
- Drug: Vincristine Sulfate
Primary outcomes (1)
- measure
- Event-Free Survival
- timeFrame
- Start of treatment up to 2 years
- description
- Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed, previously untreated B-lineage ALL, or having achieved complete remission (CR) with one course of induction chemotherapy * Patients with extramedullary disease only are eligible * Failure to one induction course of chemotherapy (these patients will be analyzed separately) * Performance status of 0-3 * Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related) * Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related) * Adequate cardiac function as assessed by history and physical examination * No active or co-existing malignancy with life expectancy less than 12 months * Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active Exclusion Criteria: * Pregnant or nursing women * Known to be human immunodeficiency virus (HIV)-positive * Philadelphia chromosome (Ph)-positive ALL * Active and uncontrolled disease/infection as judged by the treating physician * Unable or unwilling to sign the consent form * Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable chronic liver disease per investigator assessment) * Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
References
Publications (0)
Data not yet available