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Monoclonal Antibodies

Inotuzumab Ozogamicin for Leukemia and Lymphoma

Phase 2

Recruiting

Led By Maureen M O'Brien

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.

Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study

Must not have

Patients who are currently receiving or plan to receive corticosteroids except as described below

Patients who have been previously treated with inotuzumab ozogamicin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing inotuzumab ozogamicin to see if it can help patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment.

Who is the study for?

This trial is for young patients under 22 with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that's relapsed or resistant to treatment. They must have had prior therapies, be in good physical condition, and not have a history of severe liver issues or certain genetic syndromes. Females of childbearing age must agree to use contraception.

What is being tested?

The trial tests Inotuzumab Ozogamicin, an antibody linked to a toxin targeting cancer cells, on younger patients with specific types of leukemia/lymphoma. It aims to see how well it treats those whose disease has returned or hasn't responded after standard treatments.

What are the potential side effects?

Possible side effects include liver problems like sinusoidal obstruction syndrome (SOS), infusion reactions similar to allergic responses, lowered blood counts increasing infection risk, and potential harm if pregnant including fertility issues.

Eligibility Criteria

Inclusion Criteria

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

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I had B-cell lymphoma and it has come back, with a current diagnosis of M2 or M3 marrow.

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I am between 1 and 21 years old.

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I have B-ALL or B-LL with a significant presence of cancer cells in my bone marrow.

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I have ALL and have tried two different TKIs.

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It's been over 2 weeks since my small area radiation, 3 months for major areas, or 6 weeks for bone marrow radiation.

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My liver enzyme (ALT) levels are within the acceptable range for the study.

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I can care for myself, but my daily activities might be limited.

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My kidney function, measured by creatinine clearance or GFR, is good.

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My kidney function, measured by creatinine levels, is within the normal range for my age and gender.

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My condition has worsened for the second time or more.

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My condition did not improve after at least one treatment attempt.

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My leukemia cells show CD22 on their surface.

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My leukemia has been confirmed with a specific test showing more than 5% cancer cells.

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My direct bilirubin levels are within the normal range for my age.

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My condition did not improve after trying 2 different initial treatments.

Exclusion Criteria

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

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I am currently taking or planning to take corticosteroids.

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I have been treated with inotuzumab ozogamicin before.

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I do not have active eye issues related to my condition.

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My cancer has returned in the brain, testicles, or another specific area outside of the bone marrow.

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I have had SOS before, regardless of how severe it was.

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I am not currently on medication to prevent organ rejection or GVHD after a transplant.

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I have a genetic condition like Bloom syndrome or Fanconi anemia.

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I am a woman able to have children and have a recent negative pregnancy test.

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

Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1)

Secondary study objectives

Duration of CR, CRi (Cohort 1)

Event free survival (EFS) (Cohort 1)

Immunogenicity (Cohort 1)

+7 more

Other study objectives

Change in CD22 site density (Cohorts 1 and 2)

Changes in CD22 surface expression (Cohorts 1 and 2)

Changes in peripheral blood absolute B cell numbers and maturation of developing B cell populations with inotuzumab ozogamicin therapy (Cohorts 1 and 2)

+7 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

Tremor

Disease progression

Conjunctival haemorrhage

Wheezing

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

2Treatment groups

Experimental Treatment

Group I: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)Experimental Treatment13 Interventions

See Detailed Description

Group II: Cohort I (inotuzumab ozogamicin)Experimental Treatment1 Intervention

Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. (COMPLETE)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3330

Leucovorin Calcium

2011

Completed Phase 3

~12500