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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I DLTs
Phase I MTD
Phase II Median DFS
Secondary outcome measures
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
8%
Tremor
8%
Wheezing
8%
Disease progression
8%
Skin exfoliation
8%
Conjunctival haemorrhage
8%
Tonsillar hypertrophy
8%
Encephalopathy
8%
Central nervous system neoplasm
8%
Lymph node pain
8%
Dyspnoea exertional
8%
Presyncope
8%
Asthenia
8%
Pain
8%
Insomnia
8%
Pruritus
8%
Rash
8%
Splenomegaly
8%
Catheter site erythema
8%
Sinusitis
8%
Hyperkeratosis
8%
Odynophagia
8%
Septic shock
8%
Pyrexia
8%
Oropharyngeal pain
8%
Rhinorrhoea
8%
Hypoaesthesia
8%
Weight decreased
8%
Influenza
8%
Alanine aminotransferase increased
8%
Bacteraemia
8%
Blood creatinine increased
8%
Anaemia
100%
80%
60%
40%
20%
0%
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

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

Find a Location

Who is running the clinical trial?

Leland MethenyLead Sponsor
4 Previous Clinical Trials
26 Total Patients Enrolled
Leland Metheny, MDPrincipal Investigator - University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
7 Previous Clinical Trials
102 Total Patients Enrolled

Media Library

Inotuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03104491 — Phase 1 & 2
Acute Lymphoblastic Leukemia Research Study Groups: Inotuzumab Ozogamicin
Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT03104491 — Phase 1 & 2
Inotuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03104491 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions regarding who can participate in this research project?

"This lymphoma study is looking for 44 individuals that are between 16 and 75 years old."

Answered by AI

How many test subjects are in this experiment?

"This study requires 44 people who match the pre-determined inclusion criteria. The trial is running at multiple sites, such as The University of Kansas Cancer Center in Westwood and University of Nebraska Medical Center in Omaha."

Answered by AI

How many different sites are coordinating this trial?

"The primary locations for this study are The University of Kansas Cancer Center in Westwood, Kansas, University of Nebraska Medical Center in Omaha, Nebraska, and The James Cancer Hospital and Solove Research Institute in Columbus, Ohio. There 7 other sites hosting patients as well."

Answered by AI

Can you please provide some context for Inotuzumab Ozogamicin's medical research history?

"Right now, there are a total of 17 studies being conducted that focus on Inotuzumab Ozogamicin. Out of those, 2 are large-scale Phase 3 trials. Most of the research is based in Boston, Massachusetts; however, 856 different locations across the globe are running clinical trials related to this medication."

Answered by AI

What are the main goals that we hope to achieve with this trial?

"The main goal of this clinical trial, which will be evaluated over a period of time after the first dose of inotuzumab ozogamicin is given, is to find the maximum tolerable dose (MTD) for patients. Secondary outcomes include the relapse-related mortality rate in each cohort and the median overall survival time for patients in each cohort. The difference in time-to-event endpoints between groups will be tested using a 1-sided log-rank test at a significance level of 0.10."

Answered by AI

Are new patients still being accepted into this research program?

"The study is seeking more participants and the information on clinicaltrials.gov reflects this as the trial was posted on 7/31/2017 and was most recently updated on 7/19/2022."

Answered by AI

Is the age limit for this research project set at 45 years or younger?

"This clinical trial requires that participants are between the ages of 16-75, as detailed in the inclusion criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Leland Metheny 2017. "Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03104491.
All > Acute Lymphocytic Leukemia > Kansas
~0 spots leftby May 2024
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