Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Lymphoblastic Leukemia+2 MoreInotuzumab Ozogamicin - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • B-Cell Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 4 years

Up to 4 years
Incidence of adverse events
Minimal residual disease (MRD) negativity rate
Overall survival
Relapse-free survival (RFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2
50%Fatigue
42%Constipation
42%Nausea
33%Vomiting
33%Thrombocytopenia
25%Aspartate aminotransferase increased
17%Neutropenia
17%Decreased appetite
17%Headache
8%Pain
8%Encephalopathy
8%Central nervous system neoplasm
8%Presyncope
8%Insomnia
8%Pruritus
8%Rash
8%Lymph node pain
8%Splenomegaly
8%Odynophagia
8%Catheter site erythema
8%Sinusitis
8%Dyspnoea exertional
8%Wheezing
8%Hyperkeratosis
8%Disease progression
8%Septic shock
8%Pyrexia
8%Oropharyngeal pain
8%Rhinorrhoea
8%Hypoaesthesia
8%Weight decreased
8%Tremor
8%Skin exfoliation
8%Influenza
8%Alanine aminotransferase increased
8%Bacteraemia
8%Blood creatinine increased
8%Anaemia
8%Conjunctival haemorrhage
8%Asthenia
8%Tonsillar hypertrophy
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01363297) in the Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 ARM group. Side effects include: Fatigue with 50%, Constipation with 42%, Nausea with 42%, Vomiting with 33%, Thrombocytopenia with 33%.

Trial Design

1 Treatment Group

Treatment (inotuzumab ozogamicin)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Inotuzumab Ozogamicin · No Placebo Group · Phase 2

Treatment (inotuzumab ozogamicin)
Biological
Experimental Group · 1 Intervention: Inotuzumab Ozogamicin · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inotuzumab ozogamicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,604 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,339 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
15 Previous Clinical Trials
1,030 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no active or co-existing malignancy with life expectancy less than 12 months.
Patients with B-lineage ALL in at least marrow CR in salvage 1 and beyond with MRD failure at any time point after 1 month of salvage therapy are allowed, including patients who received prior allogeneic stem cell transplantation.
You have no performance status of 0, 1, or 2.