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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
Must not have
Patient with active heart disease (NYHA class > 3 as assessed by history and physical examination)
Patients with active hepatitis are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial tests a new treatment combining inotuzumab ozogamicin and chemotherapy for elderly patients with acute lymphoblastic leukemia. The drug targets and kills cancer cells, aiming to improve outcomes for those who can't undergo intensive therapy or have had a recurrence. The study will determine the appropriate dose and evaluate the treatment's effectiveness and side effects.
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe heart disease.
Select...
I do not have active hepatitis.
Select...
I have been recently diagnosed with Burkitt's Leukemia, T-cell ALL, or lymphoblastic lymphoma.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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%
Tonsillar hypertrophy
8%
Skin exfoliation
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
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
Blinatumomab
2014
Completed Phase 3
~1230
Dexamethasone
FDA approved
Mercaptopurine
2012
Completed Phase 4
~12550
Prednisone
2014
Completed Phase 4
~2500
Cytarabine
2016
Completed Phase 3
~3330
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Rituximab
1999
Completed Phase 4
~2200
Cyclophosphamide
2010
Completed Phase 4
~2320
Methotrexate
2019
Completed Phase 4
~4400
Vincristine
2003
Completed Phase 4
~2970
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Acute Lymphoblastic Leukemia (ALL) often involve monoclonal antibodies and immunotherapies that target specific antigens on cancer cells. Inotuzumab Ozogamicin, for example, is a monoclonal antibody linked to a toxic agent (CalichDMH) that specifically targets CD22 positive cancer cells, delivering the toxin directly to the cancer cells and minimizing damage to healthy cells.
This targeted approach is crucial for ALL patients as it increases the efficacy of the treatment while reducing side effects, leading to better outcomes and improved quality of life. Other similar treatments include blinatumomab, which engages T-cells to attack cancer cells, and CAR-T cell therapies, which modify a patient's own T-cells to better recognize and kill leukemia cells.
Successful Salvage of Very Early Relapse in Pediatric Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin and HLA-haploidentical Peripheral Blood Stem Cell Transplantation With Posttransplant Cyclophosphamide.
Successful Salvage of Very Early Relapse in Pediatric Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin and HLA-haploidentical Peripheral Blood Stem Cell Transplantation With Posttransplant Cyclophosphamide.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,048 Previous Clinical Trials
1,799,665 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,872 Previous Clinical Trials
41,010,501 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
760 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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.
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