Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT03488225|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2018
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia in Remission B Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative||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||Phase 2|
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).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 28, 2018|
|Estimated Primary Completion Date :||March 30, 2022|
|Estimated Study Completion Date :||March 30, 2022|
Experimental: Treatment (hyper-CVAD, inotuzumab ozogamicin)
See detailed description.
Given IT or IV
Given IV or PO
Drug: Doxorubicin Hydrochloride
Biological: Inotuzumab Ozogamicin
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Given IT, IV or PO
Drug: Vincristine Sulfate
- Event-Free Survival [ Time Frame: Start of treatment up to 3 years ]Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse.
- Overall Survival [ Time Frame: Start of treatment up to 3 years ]
- Overall Response Rate [ Time Frame: Start of treatment up to 3 years ]
- Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Start of treatment up to two years ]MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10−4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle.
- Adverse Events [ Time Frame: Start of treatment up to 30 days after last dose received. ]NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488225
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elias Jabbour||M.D. Anderson Cancer Center|