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Monoclonal Antibodies

Inotuzumab Ozogamicin Post-Transplant for Leukemia and Lymphoma

Phase 1 & 2

Recruiting

Led By Leland Metheny, MD

Research Sponsored by Leland Metheny

Eligibility Criteria Checklist

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

Must have

Diagnosis of CD22-positive Acute Lymphoblastic Leukemia

Patients with Philadelphia-like ALL

Must not have

Patients with clinical evidence of disease progression prior to enrollment

History of GVHD grade III or IV or active acute or chronic GVHD of the liver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the safety of inotuzumab ozogamicin given after stem cell transplant to people with relapsed or refractory leukemia or lymphoma.

Who is the study for?

This trial is for individuals with CD22-positive Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma who've had a stem cell transplant. They should be in remission but have minimal residual disease, and must start treatment between T+40 and T+100 days post-transplant. Good organ function and performance status are required.

What is being tested?

The study tests the safety of varying doses of Inotuzumab Ozogamicin post-transplant (Phase I) and observes side effects after transplant (Phase II). This drug, which combines an antibody with chemotherapy, targets leukemia and lymphoma cells that have come back or resisted other treatments.

What are the potential side effects?

Potential side effects include reactions related to liver toxicity such as jaundice, abdominal pain, elevated liver enzymes; blood disorders like low platelet counts; fatigue; infection risk due to immune system suppression; nausea; fever; headache.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia is CD22-positive.

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My leukemia is Philadelphia-like ALL.

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I can do most of my daily activities without help.

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I have a specific type of B-cell Non-Hodgkin's Lymphoma.

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I have been diagnosed with Non-Hodgkin's Lymphoma.

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I had a stem cell transplant for acute lymphocytic leukemia.

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I received a milder form of treatment to prepare for a stem cell transplant.

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My lymphoma is CD22-positive B-cell Non-Hodgkin's.

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My body has accepted over 80% of the donor cells after a transplant.

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I have been diagnosed with Acute Lymphoblastic Leukemia.

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I had a bone marrow transplant from a donor between 40 and 100 days ago.

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My condition is a lymphoid blast crisis of chronic myeloid leukemia.

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My cancer did not respond or has returned after chemotherapy.

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I have ALL and my previous treatment with a TKI drug did not work.

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I have had a stem cell transplant using my own cells under specific conditions.

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I am between 16 and 75 years old.

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I am able to care for myself and perform daily activities.

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My white blood cell count is stable without transfusions.

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I had a transplant while my blood cancer was in early remission but still show minimal signs of the disease.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

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

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My condition has worsened before joining this study.

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I have had severe GVHD or currently have active GVHD affecting my liver.

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My blood tests show abnormal cell changes.

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I have a history of cancer.

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My lymphoma has spread to my brain or spinal cord.

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My ALL has spread to my brain or spinal cord.

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I do not have any unmanaged ongoing illnesses.

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I have had Veno-Occlusive Disease (VOD) before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I DLTs

Phase I MTD

Phase II Median DFS

Secondary study objectives

Phase I - Percent of participants with grade 3 + AE/SAEs

Phase I Incidence of myeloid toxicity

Phase I Incidence of secondary graft failure

+18 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

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: Inotuzumab OzogamicinExperimental Treatment1 Intervention

Phase I: A maximum of 4 cycles will be allowed and doses will be adjusted in 0.1mg/m2 increments using a dose escalation scale depending on tolerability. Total range of dose levels for participants is 0.1-0.6mg/m\^2. Phase II: Participants will be enrolled until all Phase I participants have been followed and assessed for toxicity for at least 4 weeks after the fourth treatment dose of inotuzumab ozogamicin or 4 weeks after the participant goes off treatment, whichever comes first. Doses to be administered will be determined in the phase I portion of the study. The recommended phase 2 dose is 0.3mg/m2. Repeat cycles every 28 days for up to 4 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inotuzumab Ozogamicin

2011

Completed Phase 2

~360

0 / 28Eligibility criteria met