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Chemotherapy

Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Phase 3
Recruiting
Led By Jennifer L McNeer
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study entry to first event (induction failure, induction death, end of induction (eoi) minimal residual disease (mrd) >= 5%, eoc mrd >= 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying whether adding inotuzumab ozogamicin to standard chemotherapy for high-risk B-cell acute lymphoblastic leukemia (B-ALL) improves outcomes.

Who is the study for?
This trial is for patients under 25 years with high-risk B-cell Acute Lymphoblastic Leukemia, mixed phenotype acute leukemia, or B-lymphoblastic lymphoma. Eligible participants must meet specific white blood cell count criteria and be newly diagnosed based on bone marrow analysis or circulating leukemic cells. Exclusions include Down syndrome, prior significant treatment for leukemia, certain genetic conditions like Charcot-Marie-Tooth disease, pregnancy, breastfeeding women, and those not using effective contraception.
What is being tested?
The study tests if adding Inotuzumab Ozogamicin to post-induction chemotherapy improves outcomes in high-risk B-ALL patients. It also examines the effects of standard ALL therapy on MPAL and B-LLy without Inotuzumab. The trial includes various phases of chemotherapy with some patients randomly chosen to receive Inotuzumab Ozogamicin alongside other drugs like cyclophosphamide and methotrexate.
What are the potential side effects?
Inotuzumab Ozogamicin can cause liver issues, low blood counts leading to increased infection risk or bleeding problems, infusion reactions during drug administration, fatigue, fever and chills. Other chemotherapies may cause nausea/vomiting hair loss mouth sores kidney/bladder complications heart damage nerve/muscle pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry to first event (induction failure, induction death, end of induction (eoi) minimal residual disease (mrd) >= 5%, eoc mrd >= 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry to first event (induction failure, induction death, end of induction (eoi) minimal residual disease (mrd) >= 5%, eoc mrd >= 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in 5-year disease-free survival (DFS)
Secondary study objectives
5-year DFS for favorable risk subset of NCI HR B-ALL (HR favorable) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD MTX) Interim Maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex
5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX
5-year event-free survival (EFS) for patients with mixed phenotype acute leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi escalating intravenous MTX without leucovorin rescue + pegaspargase or calapargase pegol
+2 more
Other study objectives
DFS by ethnicity
DFS by race
DFS by sex
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (MPAL)Experimental Treatment18 Interventions
See detailed description for Arm IV.
Group II: Arm III (HR B-ALL EXPERIMENTAL)Experimental Treatment18 Interventions
See detailed description for Arm III.
Group III: Arm I (HR-FAV B-ALL)Experimental Treatment17 Interventions
See detailed description for Arm I
Group IV: ARM V (B-LLY)Experimental Treatment21 Interventions
See detailed description for Arm V.
Group V: Arm II (HR B-ALL CONTROL)Active Control18 Interventions
See detailed description for Arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Bone Scan
2015
Completed Phase 2
~50
Cyclophosphamide
2010
Completed Phase 4
~2310
Thioguanine
2012
Completed Phase 4
~11580
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Cytarabine
2016
Completed Phase 3
~3330
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Computed Tomography
2017
Completed Phase 2
~2790
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Dexamethasone
2007
Completed Phase 4
~2650
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Leucovorin Calcium
2011
Completed Phase 3
~12500
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Pegaspargase
2010
Completed Phase 3
~10000
Mercaptopurine
2012
Completed Phase 4
~13290
Methotrexate
2019
Completed Phase 4
~4400
Positron Emission Tomography
2011
Completed Phase 2
~2200
Prednisolone
2005
Completed Phase 4
~3570
Radiation Therapy
2017
Completed Phase 3
~7250
Vincristine Sulfate
2005
Completed Phase 3
~10270

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
235,001 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,952 Previous Clinical Trials
41,106,974 Total Patients Enrolled
Jennifer L McNeerPrincipal InvestigatorChildren's Oncology Group

Media Library

Calaspargase Pegol-mknl (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03959085 — Phase 3
Non-Hodgkin's Lymphoma Research Study Groups: ARM V (B-LLY), Arm II (HR B-ALL CONTROL), Arm III (HR B-ALL EXPERIMENTAL), Arm I (HR-FAV B-ALL), Arm IV (MPAL)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Calaspargase Pegol-mknl Highlights & Side Effects. Trial Name: NCT03959085 — Phase 3
Calaspargase Pegol-mknl (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03959085 — Phase 3
~2518 spots leftby Mar 2030
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