Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT01371630|
Recruitment Status : Recruiting
First Posted : June 13, 2011
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Untreated Adult Acute Lymphoblastic Leukemia||Biological: Blinatumomab Drug: Cyclophosphamide Drug: Cytarabine Biological: Inotuzumab Ozogamicin Other: Laboratory Biomarker Analysis Drug: Mercaptopurine Drug: Methotrexate Drug: Prednisone Biological: Rituximab Drug: Vincristine Sulfate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)|
|Actual Study Start Date :||August 26, 2011|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Treatment (inotuzumab ozogamicin, combination chemotherapy)
See Detailed Description
Given IT and IV
Biological: Inotuzumab Ozogamicin
Other: Laboratory Biomarker Analysis
Given IT, IV, and PO
Drug: Vincristine Sulfate
- Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I) [ Time Frame: 28 days ]Defined as non-hematologic grade 3 or 4 toxicities during the first course. Toxicities will be monitored using the method of Thall, Simon, and Estey. Adverse events will be summarized and toxicity rate will be estimated with a 90% credible interval.
- Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II) [ Time Frame: 2 years ]Bayesian time-to-event model will be used. Kaplan and Meier product limit method will be used to estimate the PFS along with the 95% confidence intervals for the median PFS. Univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors.
- Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II) [ Time Frame: Up to 5 years ]The precise complete remission (CR) and marrow CR rate will be defined.
- Survival in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II) [ Time Frame: Up to 1 year ]The median and 1-year survival rate will be defined. Kaplan and Meier product limit method will be used to estimate the overall survival (OS) along with the 95% confidence intervals for the median OS. Univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors.
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): NCT01371630
|Contact: Elias Jabbourfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Elias Jabbour 713-792-7026|
|Principal Investigator: Elias Jabbour|
|Principal Investigator:||Elias Jabbour||M.D. Anderson Cancer Center|