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A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

Last updated on May 9, 2018

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Study Location
Investigational Drug Services - UC San Diego Moores Cancer Center
La Jolla, California, 92037-0845 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Lymphoblastic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- CD22 expression

- Adequate liver and renal functions

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Isolated extramedullary disease

- Active Central Nervous System [CNS] disease

NCT01564784
Pfizer
Completed
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

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A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
An Open-label, Randomized Phase 3 Study Of Inotuzumab Ozogamicin Compared To A Defined Investigator's Choice In Adult Patients With Relapsed Or Refractory Cd22-positive Acute Lymphoblastic Leukemia (All)
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • Drug: inotuzumab ozogamicin
    Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
  • Drug: FLAG (fludarabine, cytarabine and G-CSF)
    Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
  • Drug: HIDAC (high dose cytarabine)
    cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
  • Drug: cytarabine and mitoxantrone
    mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
  • Experimental: Arm A
    Intervention: Drug: inotuzumab ozogamicin
  • Active Comparator: Arm B
    Interventions:
    • Drug: FLAG (fludarabine, cytarabine and G-CSF)
    • Drug: HIDAC (high dose cytarabine)
    • Drug: cytarabine and mitoxantrone
Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
325
January 2017
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   China,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Belgium,   Brazil,   Croatia,   Serbia,   Slovakia
 
NCT01564784
B1931022
2011-005491-41 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
UCB Pharma
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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