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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 Philadelphia chromosome (Ph)+ ALL can be enrolled in CR1 or CR2 and beyond. A tyrosine kinase inhibitor (TKI) will be added at the discretion of the treating physician. MRD for these patients will be defined by either 1.) a ratio of BCR-ABL1 to ABL1 by PCR of 0.01% according to the international scale for patients with p210 transcript or a ratio of BCR-ABL1 to ABL1 by PCR of 0.01% for patients with non-p210 transcripts, or 2.) detectable MRD at a level of at least 1x10^-4 (0.01%) by multicolor flow cytometry and/or by NGS.
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I have Philadelphia chromosome-positive ALL and am in my first or second complete remission.
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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.
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I have B-lineage ALL, in remission but with minimal disease after treatment, including after a stem cell transplant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse-free survival (RFS)
Secondary outcome measures
Incidence of adverse events
Minimal residual disease (MRD) negativity rate
Overall survival

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%
Tonsillar hypertrophy
8%
Disease progression
8%
Conjunctival haemorrhage
8%
Skin exfoliation
8%
Wheezing
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: 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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,325 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,307 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
988 Total Patients Enrolled

Media Library

Inotuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03441061 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (inotuzumab ozogamicin)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT03441061 — Phase 2
Inotuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03441061 — Phase 2

Frequently Asked Questions

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

What is the Inotuzumab Ozogamicin FDA rating?

"Inotuzumab Ozogamicin's safety is supported by some data, but because this is only a Phase 2 trial, there is no indication of efficacy yet. It received a score of 2 from our team."

Answered by AI

How many people can join this trial at most?

"That is correct. The listing on clinicaltrials.gov says that the study is still recruiting patients. It was first posted on February 15th, 2018 and was updated September 22nd, 2020. Currently, 40 people are needed for the trial taking place at 1 location."

Answered by AI

Is this the only time Inotuzumab Ozogamicin has been put through a clinical trial?

"There are currently 17 ongoing clinical trials researching Inotuzumab Ozogamicin. 2 of those are Phase 3 studies. The majority of these medical research projects are being conducted in Boston, Massachusetts; however, there 856 total sites running these sorts of tests."

Answered by AI

Are there any remaining vacancies for participants in this experiment?

"That is accurate. The clinicaltrials.gov website notes that this trial, which was initially publicized on February 15th 2018, is still recruiting patients. Currently, the plan is to enroll 40 people from a single location."

Answered by AI
~5 spots leftby Feb 2025