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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%
Must not have
Patients with symptomatic central nervous system (CNS) disease
Uncontrolled diabetes mellitus, cardiac disease, or pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Summary
This trial tests a new treatment combining inotuzumab ozogamicin with chemotherapy for patients with certain types of blood cancer. The new drug targets cancer cells directly and delivers a toxin to kill them. This approach aims to improve the effectiveness of treatment compared to standard chemotherapy alone. Inotuzumab ozogamicin has shown superior efficacy compared to conventional chemotherapy in patients with specific types of blood cancer.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms from my brain or spinal cord disease.
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I do not have uncontrolled diabetes, heart, or lung disease.
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I have another active cancer besides the one being treated.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free survival
Secondary study objectives
Complete remission rate
Disease-free survival
MRD-negativity rate
+3 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Cyclophosphamide
FDA approved
Mercaptopurine
FDA approved
Inotuzumab ozogamicin
FDA approved
Methotrexate
FDA approved
Cytarabine
FDA approved
Methylprednisolone
FDA approved
Rituximab
FDA approved
Prednisone
FDA approved
Vincristine
FDA approved
Dexamethasone
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Acute Lymphoblastic Leukemia (ALL) include monoclonal antibodies, chemotherapy, and immunotherapy. Monoclonal antibodies like Inotuzumab Ozogamicin target specific receptors (e.g., CD22) on leukemia cells and deliver cytotoxic agents directly to these cells, enhancing treatment precision and reducing collateral damage to healthy cells.
Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to broader side effects. Immunotherapy, such as blinatumomab, engages the patient's immune system to recognize and destroy leukemia cells.
These targeted and systemic approaches are essential for effectively managing ALL, improving patient outcomes, and minimizing adverse effects.
Phase II Trial of Inotuzumab Ozogamicin in Children and Adolescents With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: Children's Oncology Group Protocol AALL1621.
Phase II Trial of Inotuzumab Ozogamicin in Children and Adolescents With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: Children's Oncology Group Protocol AALL1621.
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
518 Previous Clinical Trials
222,271 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,994 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
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