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Alkylating agents

Inotuzumab Ozogamicin + Chemotherapy for Leukemia or Lymphoma

Phase 2
Recruiting
Led By Issa F Khouri
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
Performance status of 0 to 2.
CD22+ lymphoid malignancies including B acute lymphoblastic leukemia (B-ALL).
Must not have
Prior inotuzumab ozogamicin within 3 weeks of study entry.
Human immunodeficiency virus (HIV) positive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of a cancer drug called inotuzumab ozogamicin when given with other drugs before and after a stem cell transplant.

Who is the study for?
This trial is for adults aged 18-35 with CD22+ lymphoid malignancies, including B-ALL, who are eligible for a reduced-intensity stem cell transplant. Participants must have proper liver and kidney function, not be pregnant or breastfeeding, and have a compatible donor. Excluded are those with high peripheral blast counts, certain heart conditions, HIV, active hepatitis B or C, recent chemotherapy or radiation treatments (with some exceptions), prior inotuzumab ozogamicin treatment within 3 weeks of study entry.
What is being tested?
The trial tests the safety and effectiveness of inotuzumab ozogamicin combined with fludarabine and other chemotherapies before and after stem cell transplantation to treat leukemia or lymphoma. It aims to see if this combination can control cancer better than current methods while managing potential complications like graft-versus-host disease using tacrolimus and filgrastim.
What are the potential side effects?
Possible side effects include reactions related to the monoclonal antibody therapy such as infusion reactions; damage to organs from chemotherapy drugs; increased risk of infections due to immune suppression by medications like tacrolimus; blood disorders; fatigue; nausea; hair loss from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My cancer is a type of blood cancer that tests positive for CD22.
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I am 18-35 years old with ALL and cannot have a bone marrow transplant.
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My donor is a family member or unrelated but matches my HLA type.
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I am eligible for a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken inotuzumab ozogamicin in the last 3 weeks.
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I am HIV positive.
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My leukemia is Philadelphia chromosome positive.
Select...
I do not have any active or uncontrolled infections.
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I am unable or unwilling to sign the consent form.
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I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Incidence of grade 3 or higher renal, hepatic, cardiac, pulmonary, or neurologic toxicity
Secondary study objectives
Acute graft versus host disease (GVHD)
Chronic GVHD
Overall survival (OS)
+2 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%
Skin exfoliation
8%
Tonsillar hypertrophy
8%
Tremor
8%
Disease progression
8%
Conjunctival haemorrhage
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

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: Group II (inotuzumab ozogamicin, chemotherapy, transplant)Experimental Treatment8 Interventions
See Detailed Description.
Group II: Group I (inotuzumab ozogamicin, chemotherapy, transplant)Experimental Treatment8 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Melphalan
2008
Completed Phase 3
~1500
Bendamustine
2015
Completed Phase 3
~3230
Allogeneic Bone Marrow Transplantation
2009
Completed Phase 2
~530
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Fludarabine
2012
Completed Phase 4
~1860
Filgrastim-sndz
2017
Completed Phase 2
~100
Tacrolimus
2019
Completed Phase 4
~5510
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,204 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,421 Total Patients Enrolled
Issa F KhouriPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03856216 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03856216 — Phase 2
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03856216 — Phase 2
~3 spots leftby Mar 2025
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