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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and perform daily activities.
Select...
My cancer is a type of blood cancer that tests positive for CD22.
Select...
I am 18-35 years old with ALL and cannot have a bone marrow transplant.
Select...
My donor is a family member or unrelated but matches my HLA type.
Select...
I am eligible for a stem cell transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade 3 or higher renal, hepatic, cardiac, pulmonary, or neurologic toxicity
Secondary outcome measures
Acute graft versus host disease (GVHD)
Chronic GVHD
Overall survival (OS)
+3 moreSide effects data
From 2016 Phase 2 trial • 72 Patients • NCT0136329750%
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
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
Allogeneic Bone Marrow Transplantation
2009
Completed Phase 2
~470
Fludarabine
2012
Completed Phase 3
~1100
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Bendamustine
2015
Completed Phase 3
~2950
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Melphalan
2008
Completed Phase 3
~1500
Tacrolimus
2011
Completed Phase 4
~4740
Filgrastim-sndz
2017
Completed Phase 2
~40
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,302 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,810 Total Patients Enrolled
Issa F KhouriPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiation in the last 3 weeks, except for ibrutinib or venetoclax.I have not taken inotuzumab ozogamicin in the last 3 weeks.I am HIV positive.My leukemia is Philadelphia chromosome positive.I can take care of myself and perform daily activities.I do not have any active or uncontrolled infections.I am unable or unwilling to sign the consent form.My cancer is a type of blood cancer that tests positive for CD22.I do not have active liver or bile duct diseases, except for Gilbert's syndrome.I have active hepatitis B or C.I am 18-35 years old with ALL and cannot have a bone marrow transplant.My donor is a family member or unrelated but matches my HLA type.I am eligible for a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (inotuzumab ozogamicin, chemotherapy, transplant)
- Group 2: Group II (inotuzumab ozogamicin, chemotherapy, transplant)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the upper age limit for this research experiment 45 years or older?
"The age range for potential participants spans from eighteen to seventy, as reflected in the study's eligibility requirements."
Answered by AI
Could you please provide an estimate of the total participants involved in this trial?
"Affirmative. According to clinicaltrials.gov, this investigation is currently enrolling volunteers; it was originally announced on October 28th 2019 and the latest update happened on October 25th 2022. 44 people are expected to join from one medical centre."
Answered by AI
What pathologies is Inotuzumab Ozogamicin prescribed to address?
"Inotuzumab Ozogamicin is typically employed to combat small cell lung cancer (sclc). However, it has also been seen as a viable therapy for dermatitis, atopic issues, multiple sclerosis and b-cell lymphomas."
Answered by AI
Have any other trials been conducted to assess the efficacy of Inotuzumab Ozogamicin?
"At present, there is a large number of studies exploring the efficacy Inotuzumab Ozogamicin. Of those 1123 trials in progress, 208 have entered Phase 3 and are primarily based out of Philadelphia, Pennsylvania. However, clinical research sites across 27328 locations worldwide are examining this potential treatment option."
Answered by AI
What risks do patients face when taking Inotuzumab Ozogamicin?
"Inotuzumab Ozogamicin was assigned a safety rating of 2, as there is evidence pointing to its secure use in this Phase 2 trial but no data supporting efficacy."
Answered by AI
Is this research open to all interested individuals?
"To qualify, potential participants must have been diagnosed with lymphoma and be between 18-70 years of age. The study is aiming to recruit a total of 44 individuals."
Answered by AI
Are there any remaining vacancies for participants in this research endeavor?
"Clinicaltrials.gov reveals that this clinical trial is actively seeking participants; the study was first posted on October 28th 2019 and most recently updated on October 25th 2022."
Answered by AI
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