S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01925131|
Recruitment Status : Recruiting
First Posted : August 19, 2013
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemias of Ambiguous Lineage B-cell Adult Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Burkitt Lymphoma||Drug: cyclophosphamide Drug: vincristine sulfate Drug: prednisone Biological: inotuzumab ozogamicin Other: laboratory biomarker analysis||Phase 1|
I. To assess the safety of inotuzumab ozogamicin in combination with cyclophosphamide, vincristine (vincristine sulfate) and prednisone (CVP) and to determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia [B-ALL], mixed phenotype, and Burkitt's).
I. To estimate the preliminary activity (response rate: complete remission [CR] + complete remission with incomplete count recovery [CRi]) of this combination in the expansion cohort.
II. To estimate the frequency and severity of toxicities of this combination in this patient population.
OUTLINE: This is a dose-escalation study of inotuzumab ozogamicin.
Patients receive cyclophosphamide intravenously (IV) on day 1, vincristine sulfate IV on day 1, prednisone orally (PO) on days 1-5, and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's Leukemia)|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: Treatment (combination chemotherapy and inotuzumab ozogamicin)
Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: vincristine sulfate
Biological: inotuzumab ozogamicin
Other Name: CMC-544
Other: laboratory biomarker analysis
- MTD of inotuzumab ozogamicin with CVP defined as the highest dose studied in which the incidence of dose-limiting toxicities is < 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: 28 days ]
- Response rate (CR+CRi) [ Time Frame: Up to 3 years ]
- Frequency of toxicities graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]
- Severity of toxicities graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]
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): NCT01925131
|Contact: Cara Laubach||2016148808 ext firstname.lastname@example.org|
|Contact: Dana Sparks||2106148808 ext email@example.com|
|United States, California|
|City of Hope Comprehensive Cancer Center||Suspended|
|Duarte, California, United States, 91010|
|Stanford Cancer Institute Palo Alto||Suspended|
|Palo Alto, California, United States, 94304|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Site Public Contact 585-275-5830|
|Principal Investigator: Paul M. Barr|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Site Public Contact 866-223-8100 CancerAnswer@ccf.org|
|Principal Investigator: Aaron T. Gerds|
|United States, Texas|
|Ben Taub General Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Site Public Contact 713-873-2000|
|Principal Investigator: Martha P. Mims|
|Principal Investigator:||Anjali Advani||Southwest Oncology Group|