Your session is about to expire
← Back to Search
Monoclonal Antibodies
Blinatumomab + Inotuzumab Ozogamicin + Chemotherapy for 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
Performance status of 0-3
No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial studies different therapies to treat B acute lymphoblastic leukemia, which may work better than chemotherapy alone.
Who is the study for?
This trial is for patients with newly diagnosed B acute lymphoblastic leukemia or those who've achieved remission after one chemotherapy course. Eligible participants must have a performance status of 0-3, creatinine ≤2.0 mg/dL, bilirubin ≤2.0 mg/dL, and adequate cardiac function. Exclusions include HIV-positive individuals, active uncontrolled diseases/infections, CNS pathology like epilepsy or stroke, current autoimmune disease with potential CNS involvement, pregnant/nursing women, Philadelphia chromosome-positive ALL.Check my eligibility
What is being tested?
The study tests blinatumomab and inotuzumab ozogamicin combined with chemotherapy drugs (cyclophosphamide to prednisone) as initial treatment for B acute lymphoblastic leukemia. Blinatumomab modifies the immune system to target cancer cells; inotuzumab ozogamicin delivers toxins directly to cancer cells via CD22 binding.See study design
What are the potential side effects?
Potential side effects may include immune system changes leading to inflammation in various organs; reactions at infusion sites; general fatigue; digestive issues such as nausea and vomiting; blood disorders including low counts of different types of blood cells which can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do heavy physical work.
Select...
I don't have another cancer that could shorten my life within a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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 negativity rate
Overall response rate
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (blinatumomab, inotuzumab, combination chemotherapy)Experimental Treatment13 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Doxorubicin
FDA approved
Inotuzumab ozogamicin
FDA approved
Mercaptopurine
FDA approved
Methopterin
Not yet FDA approved
Ofatumumab
FDA approved
Prednisone
FDA approved
Rituximab
FDA approved
Sulfate ion
Not yet FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,977 Previous Clinical Trials
1,789,458 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,930,476 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
948 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 45 kg.I do not have active liver or bile duct disease, except for Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease.I have an autoimmune disease that affects my brain or nervous system.I have B-lineage ALL or lymphoblastic lymphoma, untreated or in complete remission after one chemotherapy course.I can care for myself but may not be able to do heavy physical work.I do not have any uncontrolled infections or diseases.You are pregnant or currently breastfeeding.I have had one chemotherapy course that didn't work and may be taking certain medications for my symptoms.I do not have significant brain-related health issues like epilepsy, stroke, or Parkinson's.My heart is healthy based on recent exams.My leukemia is Philadelphia chromosome positive.I don't have another cancer that could shorten my life within a year.I am HIV-positive.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (blinatumomab, inotuzumab, combination chemotherapy)
Awards:
This trial has 2 awards, including:- 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.
Which maladies are blinatumomab, inotuzumab and combination chemotherapy typically prescribed for?
"Blinatumomab, inotuzumab, and combination chemotherapy are all potential treatments for macular edema, pheochromocytomas, and eye-related issues."
Answered by AI
Have the treatments of blinatumomab, inotuzumab, and combination chemotherapy been endorsed by the FDA?
"Our Power team gave a safety rating of 2 to Treatment (blinatumomab, inotuzumab and combination chemotherapy) as it is only at Phase 2: there are some studies indicating its security but none that prove its efficacy."
Answered by AI
How many individuals are contributing to the clinical research?
"Affirmative. Clinicaltrials.gov data suggests that this trial is currently seeking participants, with an initial posting date of November 1st 2016 and a most recent update on December 19th 2022. This study intends to recruit 80 patients from single medical centre."
Answered by AI
Have any other investigations explored the effects of blinatumomab, inotuzumab or combination chemotherapy?
"Currently, there are 2172 clinical studies on-going that investigate blinatumomab, inotuzumab and combination chemotherapy. Of these trials, 484 have reached Phase 3; with the majority taking place in Ascoli Piceno Province. Nonetheless, globally 73497 sites are running experiments related to this treatment."
Answered by AI
Are there any available openings in this clinical trial for participants?
"Yes, the clinicaltrials.gov database confirms that this medical trial is still recruiting participants. It was initially posted on November 1st 2016 and last modified on December 19th 2022. 80 patients are needed from a single site to complete the study."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger