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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 belowSelect...
I had B-cell lymphoma and it has come back, with a current diagnosis of M2 or M3 marrow.
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I am between 1 and 21 years old.
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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.
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I can care for myself, but my daily activities might be limited.
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My kidney function, measured by creatinine clearance or GFR, is good.
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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.
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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreOther 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 moreSide effects data
From 2016 Phase 2 trial • 72 Patients • NCT0136329750%
Fatigue
42%
Nausea
42%
Constipation
33%
Thrombocytopenia
33%
Vomiting
25%
Aspartate aminotransferase increased
17%
Neutropenia
17%
Decreased appetite
17%
Headache
8%
Wheezing
8%
Tremor
8%
Disease progression
8%
Skin exfoliation
8%
Conjunctival haemorrhage
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
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
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
~1700
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
454 Previous Clinical Trials
237,860 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,949 Total Patients Enrolled
Maureen M O'BrienPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 30 days since my last CAR-T cell therapy session.I have had a stem cell transplant before.I am using effective birth control during and for 8 months after my treatment.Only individuals who do not have Down syndrome are eligible for Cohort 2.I had B-cell lymphoma and it has come back, with a current diagnosis of M2 or M3 marrow.I am between 1 and 21 years old.I have B-ALL or B-LL with a significant presence of cancer cells in my bone marrow.You had an allergic reaction to drugs similar to inotuzumab ozogamicin or any other drugs being used in this study.I am currently taking or planning to take corticosteroids.I have been treated with inotuzumab ozogamicin before.I do not have active eye issues related to my condition.It's been over 21 days since my last antibody treatment, and any side effects are mild.My cancer has returned in the brain, testicles, or another specific area outside of the bone marrow.I am allergic to pegaspargase but can get Erwinia asparaginase, or I can't use asparaginase due to allergy, toxicity, or access issues.I had B-lymphoblastic lymphoma and now have an M2 or M3 marrow status.I have ALL and have tried two different TKIs.It's been over 14 days since my last corticosteroid dose, not for leukemia treatment.It's been over 2 weeks since my small area radiation, 3 months for major areas, or 6 weeks for bone marrow radiation.My liver enzyme (ALT) levels are within the acceptable range for the study.I have had SOS before, regardless of how severe it was.I have recovered from previous cancer treatments with mild or no side effects now.I received a specific spinal injection within the last week.I haven't taken any cancer drugs that lower blood counts in the last 7 days.I can care for myself, but my daily activities might be limited.My kidney function, measured by creatinine clearance or GFR, is good.My kidney function, measured by creatinine levels, is within the normal range for my age and gender.I am not currently on medication to prevent organ rejection or GVHD after a transplant.I have a genetic condition like Bloom syndrome or Fanconi anemia.I may receive corticosteroids for specific reasons before starting the treatment.I do not have an active, uncontrolled infection.I am not pregnant or breastfeeding and will avoid pregnancy during treatment.I am a woman able to have children and have a recent negative pregnancy test.You are not allowed to take any other cancer medications (except for hydroxyurea and intrathecal chemotherapy) while participating in this study.If unable to provide a bone marrow sample, my blood test shows at least 1,000/uL circulating blasts or my biopsy shows CD22.My condition relapsed after a stem cell transplant.My condition has worsened for the second time or more.You cannot participate if you are currently taking a drug that is still being tested and not approved by the authorities.It's been over 14 days since my last cancer treatment, and I've recovered from its side effects.I am on standard chemotherapy and can join the trial without waiting.My condition did not improve after at least one treatment attempt.My leukemia cells show CD22 on their surface.My cancer has returned after treatment or didn't respond to initial treatments.I will use effective birth control during and for 5 months after my inotuzumab ozogamicin treatment.My leukemia has been confirmed with a specific test showing more than 5% cancer cells.My direct bilirubin levels are within the normal range for my age.I stopped taking hydroxyurea at least 24 hours before starting the new treatment.My condition did not improve after trying 2 different initial treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (inotuzumab ozogamicin)
- Group 2: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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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