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Monoclonal Antibodies

Inotuzumab Ozogamicin for Leukemia and Lymphoma

Phase 2
Recruiting
Led By Maureen M O'Brien
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
Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.
Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing inotuzumab ozogamicin to see if it can help patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment.

Who is the study for?
This trial is for young patients under 22 with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that's relapsed or resistant to treatment. They must have had prior therapies, be in good physical condition, and not have a history of severe liver issues or certain genetic syndromes. Females of childbearing age must agree to use contraception.Check my eligibility
What is being tested?
The trial tests Inotuzumab Ozogamicin, an antibody linked to a toxin targeting cancer cells, on younger patients with specific types of leukemia/lymphoma. It aims to see how well it treats those whose disease has returned or hasn't responded after standard treatments.See study design
What are the potential side effects?
Possible side effects include liver problems like sinusoidal obstruction syndrome (SOS), infusion reactions similar to allergic responses, lowered blood counts increasing infection risk, and potential harm if pregnant including fertility issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had B-cell lymphoma and it has come back, with a current diagnosis of M2 or M3 marrow.
Select...
I am between 1 and 21 years old.
Select...
I have B-ALL or B-LL with a significant presence of cancer cells in my bone marrow.
Select...
I have ALL and have tried two different TKIs.
Select...
It's been over 2 weeks since my small area radiation, 3 months for major areas, or 6 weeks for bone marrow radiation.
Select...
My liver enzyme (ALT) levels are within the acceptable range for the study.
Select...
I can care for myself, but my daily activities might be limited.
Select...
My kidney function, measured by creatinine clearance or GFR, is good.
Select...
My kidney function, measured by creatinine levels, is within the normal range for my age and gender.
Select...
My condition has worsened for the second time or more.
Select...
My condition did not improve after at least one treatment attempt.
Select...
My leukemia cells show CD22 on their surface.
Select...
My leukemia has been confirmed with a specific test showing more than 5% cancer cells.
Select...
My direct bilirubin levels are within the normal range for my age.
Select...
My condition did not improve after trying 2 different initial treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1)
Secondary outcome measures
Duration of CR, CRi (Cohort 1)
Event free survival (EFS) (Cohort 1)
Immunogenicity (Cohort 1)
+7 more
Other outcome measures
Change in CD22 site density (Cohorts 1 and 2)
Changes in CD22 surface expression (Cohorts 1 and 2)
Changes in peripheral blood absolute B cell numbers and maturation of developing B cell populations with inotuzumab ozogamicin therapy (Cohorts 1 and 2)
+7 more

Side effects data

From 2016 Phase 2 trial • 72 Patients • NCT01363297
50%
Fatigue
42%
Nausea
42%
Constipation
33%
Thrombocytopenia
33%
Vomiting
25%
Aspartate aminotransferase increased
17%
Neutropenia
17%
Decreased appetite
17%
Headache
8%
Wheezing
8%
Skin exfoliation
8%
Tremor
8%
Conjunctival haemorrhage
8%
Disease progression
8%
Tonsillar hypertrophy
8%
Encephalopathy
8%
Central nervous system neoplasm
8%
Lymph node pain
8%
Dyspnoea exertional
8%
Presyncope
8%
Asthenia
8%
Pain
8%
Insomnia
8%
Pruritus
8%
Rash
8%
Splenomegaly
8%
Catheter site erythema
8%
Sinusitis
8%
Hyperkeratosis
8%
Odynophagia
8%
Septic shock
8%
Pyrexia
8%
Oropharyngeal pain
8%
Rhinorrhoea
8%
Hypoaesthesia
8%
Weight decreased
8%
Influenza
8%
Alanine aminotransferase increased
8%
Bacteraemia
8%
Blood creatinine increased
8%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2
Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2
Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2
Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)Experimental Treatment13 Interventions
See Detailed Description
Group II: Cohort I (inotuzumab ozogamicin)Experimental Treatment1 Intervention
Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. (COMPLETE)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Cyclophosphamide
1995
Completed Phase 3
~3770
Vincristine
2003
Completed Phase 4
~2910
Methotrexate
2013
Completed Phase 4
~3800
Leucovorin Calcium
2011
Completed Phase 3
~12310
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Lumbar Puncture
2016
Completed Phase 3
~510
Pegaspargase
2005
Completed Phase 3
~9010

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,706 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,715 Previous Clinical Trials
40,953,757 Total Patients Enrolled
Maureen M O'BrienPrincipal InvestigatorChildren's Oncology Group

Media Library

Inotuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02981628 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Cohort I (inotuzumab ozogamicin), Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT02981628 — Phase 2
Inotuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02981628 — Phase 2

Frequently Asked Questions

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

How many people are being given the chance to participate in this research?

"This study requires 80 willing and eligible participants. The hospitals where this trial is being conducted are Sinai Hospital of Baltimore in Baltimore, Maryland and Arkansas Children's Hospital in Little Rock, Arkansas."

Answered by AI

Are patients currently being recruited for this trial?

"Yes, this information is available on clinicaltrials.gov. The trial was originally posted on 6/5/2017 and was last edited on 9/15/2022, meaning that the study is still looking for participants."

Answered by AI

Can you provide any prior examples of research using Inotuzumab Ozogamicin?

"City of Hope Comprehensive Cancer Center was the first to study Inotuzumab Ozogamicin in 1997 and since then, there have been 2437 completed clinical trials. As of now, 1461 studies are still active with a considerable number taking place in Baltimore, Maryland."

Answered by AI

Has Inotuzumab Ozogamicin been accepted by the FDA?

"Inotuzumab Ozogamicin's safety is based on data from Phase 2 trials. While there is some evidence that it is safe, there is no indication yet of whether or not the medication is effective."

Answered by AI

Are there a lot of clinics running this clinical trial in Canada?

"There are over 100 recruitment sites for this study, but some notable locations include Sinai Hospital of Baltimore in Maryland, Arkansas Children's Hospital, and Nicklaus Children's Hospital."

Answered by AI

Can people in their twenties join this clinical trial?

"According to the age bracket specified in this study's inclusion criteria, the youngest eligible patients are 1 year old while the oldest permissible patients are 21."

Answered by AI

Can you provide some examples of how Inotuzumab Ozogamicin is typically employed?

"Inotuzumab Ozogamicin is not only useful for treating psoriasis, but also other conditions including hodgkin disease, lymphocytic lymphomas, and iron deficiency."

Answered by AI

Who can sign up to help test this new medication?

"This clinical trial is looking for 80 participants that have refractory b acute lymphoblastic leukemia and are between the ages of 1 Year and 21. The most important criteria that applicants should meet are as follows: being >= 1 year and < 22 years of age at the time of enrollment, having relapsed after previous attempts at induction treatment, primary refractory disease with at least 2 prior induction attempts, or having second or greater relapse. Additionally, patients must have B-ALL or previously diagnosed B lymphoblastic lymphoma (B-LL) with >= 5% bone marrow blasts with or without extramedullary disease"

Answered by AI
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~6 spots leftby Dec 2024