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Monoclonal Antibodies

Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Phase 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

Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before inotuzumab ozogamicin) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy. Molecular disease or minimal residual disease is defined by a value of at least of 10^-4 (0.01%) by multicolor flow cytometry, PCR and/or next-generation sequencing (NGS).

No active or co-existing malignancy with life expectancy less than 12 months

Must not have

Active central nervous system (CNS) or extramedullary disease

Unable or unwilling to sign the consent form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a targeted cancer cell killing monoclonal antibody in patients with B-cell acute lymphocytic leukemia who have positive minimal residual disease.

Who is the study for?

This trial is for patients with B-cell acute lymphocytic leukemia showing minimal residual disease after initial treatment. Eligible participants must be in remission but still have detectable cancer cells, have a performance status of 0-2, adequate kidney and liver function, and can include those who've had stem cell transplants. It's not open to pregnant women, HIV+ individuals or those with active infections or other malignancies.

What is being tested?

The study tests Inotuzumab Ozogamicin, an antibody-drug conjugate targeting CD22 on B-cells. This phase II trial aims to see how well it works against leukemia cells that remain after primary therapy. Some patients may also receive tyrosine kinase inhibitors if they have a specific chromosome abnormality.

What are the potential side effects?

Inotuzumab Ozogamicin can cause liver problems including hepatitis and veno-occlusive disease (blood clots in the liver), low blood cell counts leading to increased infection risk and bleeding issues, infusion-related reactions such as fever or chills, fatigue, headache, nausea and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ALL is in remission but still shows signs of cancer cells.

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I do not have another cancer that could shorten my life within a year.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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My cancer has spread to my brain or nervous system.

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I cannot or do not want to sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Incidence of adverse events

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

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (inotuzumab ozogamicin)Experimental Treatment1 Intervention

Patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 8. Treatment repeats every 21-28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inotuzumab Ozogamicin

2011

Completed Phase 2

~360

0 / 5Eligibility criteria met