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Chemotherapy

Arm II (frontline chemotherapy, inotuzumab ozogamicin) for Acute Lymphoblastic Leukemia

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

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.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EFS
Secondary outcome measures
Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0
OS
Overall induction response rates
+3 more

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
~3330
Methotrexate
2019
Completed Phase 4
~4400
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Cyclophosphamide
2010
Completed Phase 4
~2320
Doxorubicin
2012
Completed Phase 3
~8030
Rituximab
1999
Completed Phase 4
~2200
Pegylated L-Asparaginase
2010
Completed Phase 2
~10
Vincristine Sulfate
2005
Completed Phase 3
~10270
Allopurinol
1999
Completed Phase 4
~6150
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Mercaptopurine
2012
Completed Phase 4
~12550
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Dexamethasone
2007
Completed Phase 4
~2640
Thioguanine
2012
Completed Phase 4
~10830

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,162 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,579 Total Patients Enrolled
daniel_deangelo@dfci.harvard.edu J. DeAngelo, MD, PhDStudy ChairDana-Farber Cancer Institute
~17 spots leftby Mar 2025
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