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Chemotherapy
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults with Newly Diagnosed B Acute Lymphoblastic Leukemia
Lansing, MI
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment and studying its side effects. The treatment is a combination of drugs given through an IV, and it is for people with a certain type of leukemia.
See full description
Eligible Conditions
- Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
EFS
Secondary study objectives
Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0
OS
Overall induction response rates
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (frontline chemotherapy, inotuzumab ozogamicin)Experimental Treatment15 Interventions
Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.
Group II: Arm I (frontline chemotherapy)Active Control13 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~4020
Methotrexate
2019
Completed Phase 4
~4400
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Cyclophosphamide
2010
Completed Phase 4
~2280
Doxorubicin
2012
Completed Phase 3
~8030
Rituximab
1999
Completed Phase 4
~2990
Pegylated L-Asparaginase
2010
Completed Phase 2
~10
Vincristine Sulfate
2004
Completed Phase 3
~10650
Allopurinol
1999
Completed Phase 4
~6150
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Mercaptopurine
2012
Completed Phase 4
~14290
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Dexamethasone
2007
Completed Phase 4
~2650
Thioguanine
2012
Completed Phase 4
~11580
Find a Location
Closest Location:Sparrow Hospital· Lansing, MI
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
519 Previous Clinical Trials
221,974 Total Patients Enrolled
46 Trials studying Leukemia
33,263 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
14,027 Previous Clinical Trials
41,152,925 Total Patients Enrolled
1,541 Trials studying Leukemia
385,774 Patients Enrolled for Leukemia
daniel_deangelo@dfci.harvard.edu J. DeAngelo, MD, PhDStudy ChairDana-Farber Cancer Institute