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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in 5-year disease-free survival (DFS)
Secondary outcome measures
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 outcome measures
DFS by ethnicity
DFS by race
DFS by sex
+5 more

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
Cyclophosphamide
1995
Completed Phase 3
~3770
Prednisolone
2005
Completed Phase 4
~2720
Dexamethasone
2007
Completed Phase 4
~2590
Positron Emission Tomography
2008
Completed Phase 2
~2240
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Pegaspargase
2005
Completed Phase 3
~9010
Cytarabine
2016
Completed Phase 3
~3310
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Leucovorin Calcium
2011
Completed Phase 3
~12310
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Mercaptopurine
2012
Completed Phase 4
~12330
Methotrexate
2013
Completed Phase 4
~3800
Radiation Therapy
2017
Completed Phase 3
~7250
Thioguanine
2012
Completed Phase 4
~10830
Vincristine Sulfate
2005
Completed Phase 3
~10110
Biospecimen Collection
2004
Completed Phase 2
~1730
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
232,943 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,920,908 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
Acute Lymphoblastic Leukemia 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)
Acute Lymphoblastic Leukemia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the usual course of treatment for Arm I (HR-FAV B-ALL)?

"Arm I (HR-FAV B-ALL) is a frequently prescribed course of treatment for multiple myeloma. Additionally, it has seen success in treating ocular conditions, subarachnoid blockage, and organ transplant rejection."

Answered by AI

Are there other ongoing research projects studying Arm I (HR-FAV B-ALL)?

"Arm I (HR-FAV B-ALL) was first studied in 1995 at the National Institutes of Health Clinical Center. There have been 4536 completed clinical trials to date, with 2283 more presently recruiting patients. Many of these studies are based out of Lexington, Kentucky."

Answered by AI

To whom is this experiment available?

"This medical trial is looking for 4772 participants between the ages of 1 and 24 who have acute lymphoblastic leukemia (ALL). Additionally, eligible patients must meet the following criteria: B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol., APEC14B1 is not a requirement for B-LLy patients but for"

Answered by AI

Has Arm I (HR-FAV B-ALL) been cleared by the FDA?

"Arm I (HR-FAV B-ALL) is classified as having a safety rating of 3. This means that while it is still in Phase 3 clinical trials, there is evidence supporting its efficacy and multiple rounds data affirming its safety."

Answered by AI

For patients that are elderly, is this study an option?

"For this specific clinical trial, only individuals aged 1 year to 24 are eligible. Out of the nearly 4000 active trials, 978 involve patients under 18 years old and 3101 concern people over 65."

Answered by AI

How many trial sites are there in total?

"Currently, this study is enrolling participants at 100 sites. The locations are in Lexington, Newark and Paterson as well as other cities. To limit the amount of travel required, please select the location nearest you when signing up for the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
2019. "Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03959085.
~2838 spots leftby Mar 2030
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