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Anti-tumor antibiotic
Inotuzumab Ozogamicin + Chemotherapy for Leukemia and Lymphoma
Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 50 years
Cardiac ejection fraction > 40%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing a targeted drug therapy combined with chemotherapy to only chemotherapy for leukemia and lymphoma.
Who is the study for?
Adults aged 50 or older with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma can join this trial. They must have certain levels of cancer cells in their blood/marrow, be CD22 positive, and not have had much prior treatment for ALL. Good kidney/liver function and a decent performance status are required. Those with active hepatitis C/B virus infections under control may qualify but must use birth control due to the risks from therapy.Check my eligibility
What is being tested?
The study is testing if adding Inotuzumab Ozogamicin (a targeted antibody-drug conjugate) to lower-dose chemotherapy is more effective than usual chemotherapy alone for treating these cancers. The goal is to see if this combination can better shrink the cancer and prevent it from coming back.See study design
What are the potential side effects?
Inotuzumab Ozogamicin might cause liver problems, infusion reactions, low blood cell counts leading to increased infection risk, bleeding/bruising issues, fatigue, nausea, fever, headache and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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My heart pumps blood effectively.
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I have been diagnosed with B-cell ALL or LBL with at least 5% cancer cells in my bone marrow or blood.
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My liver is functioning well.
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.Secondary outcome measures
Complete remission rate
Disease-free survival
Event-free survival
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (inotuzumab ozogamicin, chemotherapy)Experimental Treatment10 Interventions
Induction: For cycles 1-4 on days 2 and 8, patients receive inotuzumab ozogamicin IV and IT chemotherapy consisting of alternating Cytarabine and Methotrexate. Patients with leukemic blasts expressing CD20 also receive rituximab IV on days 2 and 8 of cycles 1-4. For cycles 1,3,5,7, patients receive cyclophosphamide intravenously (IV) on days 1-3, mesna IV, vincristine IV on days 1 and 8, and dexamethasone IV or orally (PO) on days 1-4 and 11-14. For cycles 2,4,6,8, patients receive methotrexate on day 1, cytarabine IV on days 2-3, and methylprednisolone on days 1-3. Patients >= 70 years of age receive either 2 or 4 cycles of treatment. Patients < 70 years of age receive up to 8 cycles of treatment.
Maintenance: Patients receive vincristine IV on day 1, prednisone PO on days 1-5, mercaptopurine PO on days 1-28, and methotrexate PO weekly. Treatment occurs for up to 24 cycles or 2 years, whichever comes first, in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (chemotherapy)Active Control10 Interventions
Induction: For cycles 1-4 on days 2 and 8, patients receive IT chemotherapy consisting of alternating Cytarabine and Methotrexate. Patients with leukemic blasts expressing CD20 also receive rituximab IV on days 2 and 8 of cycles 1-4. For cycles 1,3,5,7, patients receive cyclophosphamide intravenously (IV) on days 1-3, mesna IV, doxorubicin IV on day 4, vincristine IV on days 1 and 8, and dexamethasone IV or orally (PO) on days 1-4 and 11-14. For cycles 2,4,6,8, patients receive methotrexate on day 1, cytarabine IV on days 2-3, and methylprednisolone on days 1-3. Patients >= 70 years of age receive either 2 or 4 cycles of treatment. Patients < 70 years of age receive up to 8 cycles of treatment.
Maintenance: Patients receive vincristine IV on day 1, prednisone PO on days 1-5, mercaptopurine PO on days 1-28, and methotrexate PO weekly. Treatment occurs for up to 24 cycles or 2 years, whichever comes first, in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved
Inotuzumab ozogamicin
FDA approved
Cyclophosphamide
FDA approved
Dexamethasone
FDA approved
Methotrexate
FDA approved
Cytarabine
FDA approved
Methylprednisolone
FDA approved
Rituximab
FDA approved
Prednisone
FDA approved
Mercaptopurine
FDA approved
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,572 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,375 Total Patients Enrolled
Marlise R. Luskin, MD, MSCEStudy ChairDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had hepatitis C but it's cleared and my liver is healthy.I am 50 years old or older.I have symptoms from my brain or spinal cord disease.I do not have uncontrolled diabetes, heart, or lung disease.I have provided a bone marrow or blood sample for disease analysis.My cancer cells are CD22 positive.I have hepatitis B but am on treatment that controls it well.I can care for myself but may not be able to do active work, or I'm mostly in bed due to my illness.I agree to use birth control during the study.My heart pumps blood effectively.I have been diagnosed with B-cell ALL or LBL with at least 5% cancer cells in my bone marrow or blood.My liver is functioning well.I have another active cancer besides the one being treated.I am HIV positive but not on effective treatment, with undetectable viral load in the last 6 months.I haven't had chemotherapy for ALL, but may have had low-dose radiation or been on steroids for other reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (chemotherapy)
- Group 2: Arm A (inotuzumab ozogamicin, chemotherapy)
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is Arm A (inotuzumab ozogamicin, chemotherapy) an effective and secure treatment option?
"Our analysts assigned a safety score of 2 to Arm A (inotuzumab ozogamicin, chemotherapy), since this is only in Phase 2 and there is evidence for its security but not yet it's efficacy."
Answered by AI
Is the opportunity to participate in this clinical trial still available?
"That is correct. Clinicaltrials.gov's records show that the trial, which was originally posted on February 27th 2023, is now actively recruiting participants. 66 individuals are needed to be enrolled at two different centers"
Answered by AI
What is the current intake quota for this research endeavor?
"Affirmative. According to clinicaltrials.gov, the information about this study was first published on February 27th 2023 and recently updated on July 26th 2023. The trial is presently looking for 66 participants who are willing to take part across 2 sites."
Answered by AI
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