What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL), such as Inotuzumab Ozogamicin, which targets CD22 receptors, are associated with several side effects. Inotuzumab Ozogamicin can cause hepatotoxicity, including potentially fatal sinusoidal obstruction syndrome (SOS). Other monoclonal antibody therapies, like Blinatumomab, can lead to cytokine release syndrome (CRS) and neurologic toxicities, including encephalopathy and convulsions. General chemotherapy side effects for ALL treatments may include neutropenia, thrombocytopenia, nausea, vomiting, and increased risk of infections.

What prior FDA approvals exist?

Inotuzumab ozogamicin is an FDA-approved monoclonal antibody targeting CD22 receptors, used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It delivers the cytotoxic agent CalichDMH directly to cancer cells. Similar FDA-approved treatments include blinatumomab, a bispecific T-cell engager that targets CD19 on B-cells, and tisagenlecleucel, a CAR-T cell therapy targeting CD19. These therapies represent significant advancements in targeted treatment options for ALL.

What other types of research exist?

Promising novel alternatives to Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia patients include Blinatumomab (a bispecific T-cell engager targeting CD19), CAR T-cell therapies such as Tisagenlecleucel and Brexucabtagene Autoleucel, and novel antibody-drug conjugates like Loncastuximab Tesirine. These therapies have shown significant efficacy in clinical trials and are emerging as important options for ALL treatment.

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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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Complete remission rate

Disease-free survival

Event-free survival

+4 more

Awards & 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

Cytarabine

FDA approved

Methotrexate

FDA approved

Methylprednisolone

FDA approved

Rituximab

FDA approved

Prednisone

FDA approved

Vincristine

FDA approved

Dexamethasone

FDA approved

0 / 7Eligibility criteria met

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.