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Monoclonal Antibodies
Immunotherapy + Chemotherapy for Acute Lymphoblastic Leukemia
Phase 1 & 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new leukemia treatment combining immunotherapy and chemotherapy.
Who is the study for?
This trial is for patients aged 60+ with untreated acute lymphoblastic leukemia (ALL), including those unfit for intensive chemotherapy due to comorbidities like heart or kidney disease. It's also open to any age with refractory-relapsed ALL, certain high-grade B-cell lymphomas, and marrow involvement. Excluded are those with newly diagnosed Burkitt's Leukemia/Lymphoma, T-cell ALL/lymphoma, active heart disease, ejection fraction <40%, active hepatitis, or who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of inotuzumab ozogamicin combined with chemotherapy in treating ALL. Inotuzumab ozogamicin targets cancer cells by delivering a toxin directly to them. The study includes other drugs like blinatumomab that help the immune system fight cancer and various chemotherapies aimed at stopping cancer cell growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the monoclonal antibody therapy such as infusion reactions and organ inflammation; toxicity from the delivered toxin affecting liver function; common chemo side effects like nausea, fatigue, hair loss; increased risk of infections; and potential impact on blood cell counts leading to anemia or bleeding issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I)
Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II)
Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)
+1 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
3Treatment groups
Experimental Treatment
Group I: Arm III (inotuzumab ozogamicin, combination chemotherapy)Experimental Treatment8 Interventions
See Detailed Description Arm III
Group II: Arm II (inotuzumab ozogamicin, combination chemotherapy)Experimental Treatment11 Interventions
See Detailed Description Arm II
Group III: Arm I (inotuzumab ozogamicin, combination chemotherapy)Experimental Treatment11 Interventions
See Detailed Description Arm I
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3770
Methotrexate
2013
Completed Phase 4
~3800
Mercaptopurine
2012
Completed Phase 4
~12330
Blinatumomab
2014
Completed Phase 3
~1210
Dexamethasone
FDA approved
Prednisone
2014
Completed Phase 4
~2370
Vincristine
2003
Completed Phase 4
~2910
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,070 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,578 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
752 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart disease.I do not have active hepatitis.I am 60 or older with untreated ALL, and may have had minimal prior therapy.I am 18-59 years old with untreated ALL, have certain health issues, and may or may not have started treatment.I have been recently diagnosed with Burkitt's Leukemia, T-cell ALL, or lymphoblastic lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (inotuzumab ozogamicin, combination chemotherapy)
- Group 2: Arm I (inotuzumab ozogamicin, combination chemotherapy)
- Group 3: Arm II (inotuzumab ozogamicin, combination chemotherapy)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
What is the scope of this research project in terms of participants?
"Affirmative. Clinicaltrials.gov states that this clinical trial, which initially went live on August 26th 2011, is now actively recruiting patients. A total of 276 participants are required across a single medical facility."
Answered by AI
Could you please detail the precedent research conducted on Inotuzumab Ozogamicin?
"Presently, 1633 clinical trials for Inotuzumab Ozogamicin are ongoing; 353 of those being Phase 3. The primary location is Bethesda, Maryland though there thousands more sites worldwide running these studies."
Answered by AI
What medical condition is Inotuzumab Ozogamicin generally prescribed for?
"Primarily used to treat pheochromocytomas, inotuzumab ozogamicin can also be utilized for ulcerative colitis management and viral conditions such as varicella-zoster virus acute retinal necrosis and multiple myeloma."
Answered by AI
Are there any vacancies available for enrolment in this experiment?
"As registered with clinicaltrials.gov, this research is currently open to participants, having first been posted on August 26th 2011 and most recently revised on October 11th 2022."
Answered by AI
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