Inotuzumab Ozogamicin + Chemotherapy for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining inotuzumab ozogamicin with chemotherapy for young adults newly diagnosed with B acute lymphoblastic leukemia (ALL). Researchers aim to determine if adding inotuzumab ozogamicin, which targets specific cancer cells, to standard chemotherapy can improve treatment outcomes. Patients recently diagnosed with CD-22 positive B-cell ALL and without significant prior treatment may be suitable candidates. The study includes two groups: one receiving standard chemotherapy and the other receiving the same chemotherapy plus inotuzumab ozogamicin. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients should not have had prior therapy for acute leukemia, except for limited emergency treatments. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that inotuzumab ozogamicin, the treatment under study in this trial, has generally been well-tolerated in past studies. However, some patients experienced serious side effects. Common side effects include infections, fever, and tiredness. More severe issues can arise, such as liver problems, specifically hepatic veno-occlusive disease (VOD), which affects blood flow in the liver. Additionally, some patients may experience low blood cell counts, increasing the risk of infection and bleeding.
While these side effects are serious, they do not occur in everyone. It's important to weigh these risks against the potential benefits when considering participation in a clinical trial. Consulting healthcare professionals is crucial to understand what these risks might mean personally.12345Why do researchers think this study treatment might be promising?
Researchers are excited about inotuzumab ozogamicin for treating B Acute Lymphoblastic Leukemia (ALL) because it offers a targeted approach that differs from standard chemotherapy. Unlike traditional treatments that broadly attack rapidly dividing cells, inotuzumab ozogamicin is an antibody-drug conjugate. This means it specifically targets cancerous B cells, delivering a potent chemotherapy agent directly to them, which could potentially reduce damage to healthy cells and improve treatment outcomes. This precision targeting helps to minimize side effects and enhances the effectiveness of the treatment against leukemia cells.
What evidence suggests that this trial's treatments could be effective for B acute lymphoblastic leukemia?
Research has shown that inotuzumab ozogamicin can effectively treat B acute lymphoblastic leukemia. One study found that about 80.7% of patients receiving this treatment achieved complete or nearly complete remission, compared to only 29.4% of those who did not receive it. In this trial, participants in Arm II will receive inotuzumab ozogamicin alongside chemotherapy. This treatment targets cancer cells and delivers a toxic substance to them, stopping their growth. This targeted approach has led to better response rates and may improve survival for patients. Overall, inotuzumab ozogamicin shows promise when combined with chemotherapy for better outcomes in young adults with this type of leukemia.46789
Who Is on the Research Team?
daniel_deangelo@dfci.harvard.edu J. DeAngelo, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for young adults newly diagnosed with B-cell acute lymphoblastic leukemia that tests positive for CD22. Participants must not have Burkitt type ALL, certain genetic changes (like BCR-ABL), or Down syndrome. Only limited prior treatment is allowed, and women must not be pregnant or nursing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Remission Induction Therapy
Patients receive a combination of chemotherapy drugs including allopurinol, cytarabine, daunorubicin, vincristine, dexamethasone, pegylated L-aspiraginase, and methotrexate to induce remission.
Remission Consolidation Chemotherapy
Patients receive cyclophosphamide, cytarabine, mercaptopurine, vincristine, pegylated L-aspiraginase, and methotrexate to consolidate remission.
Interim Maintenance Chemotherapy
Patients receive vincristine, methotrexate, and pegylated L-aspiraginase to maintain remission.
Delayed Intensification
Patients receive a more intensive chemotherapy regimen to further reduce leukemia cells.
Maintenance Therapy
Patients receive ongoing chemotherapy to maintain remission over a long period.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Allopurinol
- Bone Marrow Aspiration and Biopsy
- Cyclophosphamide
- Cytarabine
- Daunorubicin Hydrochloride
- Dexamethasone
- Doxorubicin
- Inotuzumab Ozogamicin
- Mercaptopurine
- Methotrexate
- Pegylated L-Asparaginase
- Rituximab
- Thioguanine
- Vincristine Sulfate
Trial Overview
The study compares standard chemotherapy with or without the addition of inotuzumab ozogamicin, a targeted antibody drug. Patients are partly randomized to receive either just chemo or chemo plus this new drug to see if outcomes improve.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.
See detailed description.
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Efficacy and safety of inotuzumab ozogamicin and its ... - PMC
The primary outcomes were overall response (OR), complete remission (CR), minimal residual disease (MRD) negativity, overall survival (OS), and ...
2.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/1567/552963/The-addition-of-inotuzumab-ozogamicin-to-frontlineThe addition of inotuzumab ozogamicin to frontline hyper ...
The addition of inotuzumab ozogamicin to frontline hyper-CVAD and sequential blinatumomab leads to durable survival outcomes in adults with ...
Besponsa (Inotuzumab Ozogamicin) Approved for Adults ...
Overall, 80.7% in the inotuzumab ozogamicin arm achieved complete remission or complete remission with incomplete hematologic recovery versus 29.4% of patients ...
4.
hematologyadvisor.com
hematologyadvisor.com/reports/inotuzumab-ozogamicin-blinatumomab-may-be-superior-chemotherapy-some-elderly-patients-b-cell-all/Inotuzumab Ozogamicin, Blinatumomab May Be Superior ...
The most common grade 3 or worse AEs were neutrophil count decrease (87.9%), platelet count decrease (72.7%), and anemia (42.4%). There was 1 ...
BESPONSA® (inotuzumab ozogamicin) CR/CRi | Safety Info
In the remission analysis population of 109 patients randomized to receive BESPONSA, 73% (n=64/88) responded in Cycle 1 and 24% (n=21/88) responded in Cycle 2.
BESPONSA® (inotuzumab ozogamicin) Safety Information
The most common (≥2%) serious adverse reactions (ARs) were infection, febrile neutropenia, hemorrhage, abdominal pain, pyrexia, VOD, and fatigue ; References.
7.
pfe-pfizercom-prod.s3.amazonaws.com
pfe-pfizercom-prod.s3.amazonaws.com/products/material_safety_data/BESPONSA_Inotuzumab_ozogamicin_20-march-2019.pdfSAFETY DATA SHEET
Precautionary Statements: P201 - Obtain special instructions before use. P260 - Do not breathe dust/fume/gas/mist/vapors/spray.
Besponsa™ Inotuzumab ozogamicin Powder for ...
There is limited safety information available in patients with total bilirubin greater than 1.5 × ULN and/or AST/ALT greater than 2.5 × ULN prior to dosing.
Safety evaluation of inotuzumab ozogamicin - PMC - NIH
Clinical trial data indicate that patients treated with InO often experience myelosuppression, particularly neutropenia and thrombocytopenia, which may lead to ...
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