What is the mechanism of action of this treatment?

Common treatments for Acute Lymphoblastic Leukemia (ALL) often involve monoclonal antibodies and immunotherapies that target specific antigens on cancer cells. Inotuzumab Ozogamicin, for example, is a monoclonal antibody linked to a toxic agent (CalichDMH) that specifically targets CD22 positive cancer cells, delivering the toxin directly to the cancer cells and minimizing damage to healthy cells. This targeted approach is crucial for ALL patients as it increases the efficacy of the treatment while reducing side effects, leading to better outcomes and improved quality of life. Other similar treatments include blinatumomab, which engages T-cells to attack cancer cells, and CAR-T cell therapies, which modify a patient's own T-cells to better recognize and kill leukemia cells.

What side effects are associated with this type of intervention?

Common side effects of treatments for Acute Lymphoblastic Leukemia, particularly those similar to Inotuzumab Ozogamicin, include infusion-related reactions, cytopenias (neutropenia, thrombocytopenia, anemia), liver toxicity, and infections. Other potential side effects are nausea, headache, and fatigue. Severe adverse events can include veno-occlusive disease (VOD) and increased risk of serious infections due to immunosuppression.

What prior FDA approvals exist?

Inotuzumab Ozogamicin, a monoclonal antibody linked to the cytotoxic agent CalichDMH, targets CD22 positive cancer cells and has been studied for the treatment of Acute Lymphoblastic Leukemia (ALL). 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 leverage the immune system to target and kill leukemia cells, representing significant advancements in the treatment of ALL.

What other types of research exist?

Promising alternatives to Inotuzumab Ozogamicin for treating Acute Lymphoblastic Leukemia include Blinatumomab, a bispecific T-cell engager antibody targeting CD19, and CAR-T cell therapies such as Tisagenlecleucel, which also targets CD19. These therapies have shown significant efficacy in clinical trials and are considered advanced options for ALL treatment.

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Monoclonal Antibodies

Immunotherapy + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Led By Elias Jabbour

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patient with active heart disease (NYHA class > 3 as assessed by history and physical examination)

Patients with active hepatitis are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 60 Other Conditions

Summary

This trial tests a new treatment combining inotuzumab ozogamicin and chemotherapy for elderly patients with acute lymphoblastic leukemia. The drug targets and kills cancer cells, aiming to improve outcomes for those who can't undergo intensive therapy or have had a recurrence. The study will determine the appropriate dose and evaluate the treatment's effectiveness and side effects.

Who is the study for?

This trial is for patients aged 60+ with untreated acute lymphoblastic leukemia (ALL), including those unfit for intensive chemotherapy due to comorbidities like heart or kidney disease. It's also open to any age with refractory-relapsed ALL, certain high-grade B-cell lymphomas, and marrow involvement. Excluded are those with newly diagnosed Burkitt's Leukemia/Lymphoma, T-cell ALL/lymphoma, active heart disease, ejection fraction <40%, active hepatitis, or who are pregnant/breastfeeding.

What is being tested?

The trial tests the safety and effectiveness of inotuzumab ozogamicin combined with chemotherapy in treating ALL. Inotuzumab ozogamicin targets cancer cells by delivering a toxin directly to them. The study includes other drugs like blinatumomab that help the immune system fight cancer and various chemotherapies aimed at stopping cancer cell growth.

What are the potential side effects?

Potential side effects include reactions related to the monoclonal antibody therapy such as infusion reactions and organ inflammation; toxicity from the delivered toxin affecting liver function; common chemo side effects like nausea, fatigue, hair loss; increased risk of infections; and potential impact on blood cell counts leading to anemia or bleeding issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe heart disease.

Select...

I do not have active hepatitis.

Select...

I have been recently diagnosed with Burkitt's Leukemia, T-cell ALL, or lymphoblastic lymphoma.

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.

Primary study objectives

Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I)

Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II)

Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)

+1 more

Side effects data

From 2016 Phase 2 trial • 72 Patients • NCT01363297

50%

Fatigue

42%

Nausea

42%

Constipation

33%

Thrombocytopenia

33%

Vomiting

25%

Aspartate aminotransferase increased

17%

Neutropenia

17%

Decreased appetite

17%

Headache

Skin exfoliation

Tonsillar hypertrophy

Wheezing

Disease progression

Conjunctival haemorrhage

Tremor

Encephalopathy

Central nervous system neoplasm

Lymph node pain

Dyspnoea exertional

Presyncope

Asthenia

Pain

Insomnia

Pruritus

Rash

Splenomegaly

Catheter site erythema

Sinusitis

Hyperkeratosis

Odynophagia

Septic shock

Pyrexia

Oropharyngeal pain

Rhinorrhoea

Hypoaesthesia

Weight decreased

Influenza

Alanine aminotransferase increased

Bacteraemia

Blood creatinine increased

Anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2

Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2

Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (inotuzumab ozogamicin, combination chemotherapy)Experimental Treatment8 Interventions

See Detailed Description Arm III

Group II: Arm II (inotuzumab ozogamicin, combination chemotherapy)Experimental Treatment11 Interventions

See Detailed Description Arm II

Group III: Arm I (inotuzumab ozogamicin, combination chemotherapy)Experimental Treatment11 Interventions

See Detailed Description Arm I

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1230

Dexamethasone

FDA approved

Mercaptopurine

2012

Completed Phase 4

~12550

Prednisone

2014

Completed Phase 4

~2500

Cytarabine

2016

Completed Phase 3

~3330

Inotuzumab Ozogamicin

2011

Completed Phase 2

~360

Rituximab

1999

Completed Phase 4

~2990

Cyclophosphamide

2010

Completed Phase 4

~2310

Methotrexate

2019

Completed Phase 4

~4400

Vincristine

2003

Completed Phase 4

~2970

0 / 3Eligibility 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) often involve monoclonal antibodies and immunotherapies that target specific antigens on cancer cells. Inotuzumab Ozogamicin, for example, is a monoclonal antibody linked to a toxic agent (CalichDMH) that specifically targets CD22 positive cancer cells, delivering the toxin directly to the cancer cells and minimizing damage to healthy cells. This targeted approach is crucial for ALL patients as it increases the efficacy of the treatment while reducing side effects, leading to better outcomes and improved quality of life. Other similar treatments include blinatumomab, which engages T-cells to attack cancer cells, and CAR-T cell therapies, which modify a patient's own T-cells to better recognize and kill leukemia cells.

Successful Salvage of Very Early Relapse in Pediatric Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin and HLA-haploidentical Peripheral Blood Stem Cell Transplantation With Posttransplant Cyclophosphamide.