Clinical Trials Directory

Trials / Terminated

TerminatedNCT03488225

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
4 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the clinical efficacy of the sequential combination of hyper-CVAD (hyperfractionated cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine) + inotuzumab ozogamicin in patients with newly diagnosed B-cell acute lymphocytic leukemia (ALL) in terms of event-free survival (EFS). SECONDARY OBJECTIVES: I. To evaluate other efficacy endpoints such as overall survival, overall response rate, minimal residual disease (MRD) negativity rate as well as the safety of this combination. OUTLINE: INTENSIVE CHEMOTHERAPY: Patients receive cyclophosphamide intravenously (IV) over 3 hours every 12 hours on days 1-3 and dexamethasone IV or orally (PO) on days 1-4 and 11-14 of courses 1 and 3. Patients may receive ofatumumab IV over 2 hours on days 1, 2 and 11 of course 1, days 1 and 8 of courses 2 and 4, and days 1 and 11 of course 3, or rituximab IV over 2 hours on days 1 and 11 of courses 1 and 3, and days 1 and 8 of courses 2 and 4. Patients also receive methotrexate intrathecally (IT) on day 2 of courses 1 and 3, IV over 24 hours on day 1 and IT on day 8 of courses 2 and 4, doxorubicin hydrochloride IV over 24 hours on day 4 of courses 1 and 3, vincristine sulfate IV over 1 hour on days 4 and 11 of courses 1 and 3, cytarabine IT on day 7 of courses 1 and 3, and IV over 2 hours every 12 hours on days 2 and 3, and IT on day 5 of courses 2 and 4, leucovorin calcium IV 4 times a days on day 2 of courses 2 and 4. Patients then receive inotuzumab ozogamicin IV over 1 hour on days 1 and 8 of courses 5-8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive mercaptopurine PO thrice a day, methotrexate PO once a week, vincristine sulfate IV over 1 hour on day 1 and prednisone PO on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 6 months.

Conditions

Interventions

TypeNameDescription
DRUGCyclophosphamideGiven IV
DRUGCytarabineGiven IT or IV
DRUGDexamethasoneGiven IV or PO
DRUGDoxorubicin HydrochlorideGiven IV
BIOLOGICALInotuzumab OzogamicinGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGLeucovorin CalciumGiven IV
DRUGMercaptopurineGiven PO
DRUGMethotrexateGiven IT, IV or PO
BIOLOGICALOfatumumabGiven IV
DRUGPrednisoneGiven PO
BIOLOGICALRituximabGiven IV
DRUGVincristine SulfateGiven IV

Timeline

Start date
2018-03-28
Primary completion
2020-04-02
Completion
2020-04-02
First posted
2018-04-04
Last updated
2024-07-16
Results posted
2021-04-13

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03488225. Inclusion in this directory is not an endorsement.