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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

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 below
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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:
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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 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.
Secondary outcome measures
Complete remission rate
Disease-free survival
Event-free survival
+4 more

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
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

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.

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,560 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,335 Total Patients Enrolled
Marlise R. Luskin, MD, MSCEStudy ChairDana-Farber Cancer Institute

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05303792 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Arm A (inotuzumab ozogamicin, chemotherapy), Arm B (chemotherapy)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT05303792 — Phase 2
Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05303792 — Phase 2
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