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Inotuzumab Ozogamicin for Leukemia and Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 72 Patients • NCT01363297Trial Design
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- 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.
- Group 1: Cohort I (inotuzumab ozogamicin)
- Group 2: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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"
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