Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Monoclonal antibodies
Disqualifiers: Pregnancy, HIV, CNS disease, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial studies how well inotuzumab ozogamicin works in treating patients with B-cell acute lymphocytic leukemia with positive minimal residual disease. Inotuzumab ozogamicin is a monoclonal antibody called inotuzumab linked to a toxic agent called ozogamicin. Inotuzumab ozogamicin attaches to B cell-specific CD22 cancer cells in a targeted way and kills them.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had monoclonal antibody therapy, radiotherapy, or certain cancer chemotherapies within 2 weeks before starting the study.
What data supports the effectiveness of the drug Inotuzumab Ozogamicin for treating acute lymphoblastic leukemia?
Inotuzumab Ozogamicin has shown better results than standard chemotherapy for patients with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia, improving remission rates and survival chances. It also helps more patients become eligible for stem cell transplants, which can be a crucial step in treatment.
12345Is Inotuzumab Ozogamicin safe for humans?
Inotuzumab Ozogamicin has been shown to be generally well-tolerated in patients with acute lymphoblastic leukemia, but some common side effects include blood-related issues and a condition called sinusoidal obstruction syndrome (a liver problem). It has been studied in various trials, and while it shows promise, patients should be aware of these potential risks.
12567What makes the drug Inotuzumab Ozogamicin unique for treating acute lymphoblastic leukemia?
Inotuzumab Ozogamicin is unique because it is a targeted therapy that combines an antibody specifically designed to attach to a protein called CD22 on leukemia cells with a powerful toxin, calicheamicin, to kill the cancer cells. This approach is different from standard chemotherapy and has shown better results in patients with relapsed or refractory acute lymphoblastic leukemia, including higher remission rates and improved survival.
12456Eligibility Criteria
This trial is for patients with B-cell acute lymphocytic leukemia showing minimal residual disease after initial treatment. Eligible participants must be in remission but still have detectable cancer cells, have a performance status of 0-2, adequate kidney and liver function, and can include those who've had stem cell transplants. It's not open to pregnant women, HIV+ individuals or those with active infections or other malignancies.Inclusion Criteria
My ALL is in remission but still shows signs of cancer cells.
I have Philadelphia chromosome-positive ALL and am in my first or second complete remission.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 X ULN
+5 more
Exclusion Criteria
Pregnant or nursing women
I haven't had monoclonal antibody therapy in the last 2 weeks.
I haven't had major cancer treatment or experimental drugs in the last 2 weeks.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive inotuzumab ozogamicin intravenously over 1 hour on days 1 and 8. Treatment repeats every 21-28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
18-24 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 years
1 visit at 30 days, then every 6 months
Participant Groups
The study tests Inotuzumab Ozogamicin, an antibody-drug conjugate targeting CD22 on B-cells. This phase II trial aims to see how well it works against leukemia cells that remain after primary therapy. Some patients may also receive tyrosine kinase inhibitors if they have a specific chromosome abnormality.
1Treatment groups
Experimental Treatment
Group I: Treatment (inotuzumab ozogamicin)Experimental Treatment1 Intervention
Patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 8. Treatment repeats every 21-28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Inotuzumab Ozogamicin is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Besponsa for:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
🇺🇸 Approved in United States as Besponsa for:
- Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Inotuzumab ozogamicin in the treatment of B-cell acute lymphoblastic leukemia. [2022]Inotuzumab ozogamicin (CMC-544) is a humanized anti-CD22 monoclonal antibody conjugated with calicheamicin. Preclinical data indicate activity against B-cell tumors and early results from clinical trials indicate activity against B-cell lineage acute lymphoblastic leukemia (ALL).
Patient-reported outcomes from a phase 3 randomized controlled trial of inotuzumab ozogamicin versus standard therapy for relapsed/refractory acute lymphoblastic leukemia. [2019]Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior clinical activity versus standard-of-care (SOC) chemotherapies for relapsed/refractory B-cell acute lymphoblastic leukemia in the phase 3 randomized controlled INO-VATE trial. The authors assessed patient-reported outcomes (PROs) from that study.
Inotuzumab Ozogamicin in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. [2020]Despite initial complete remission rates of up to 90%, long-term, disease-free survival remains poor in patients with newly diagnosed acute lymphoblastic leukemia (ALL). Response to salvage chemotherapy is suboptimal; therefore, novel therapeutic agents are being investigated in order to improve outcomes in these patients. Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate recently approved by the US Food and Drug Administration for the treatment of adults with relapsed or refractory B-cell precursor ALL. Inotuzumab ozogamicin improves response rate, minimal residual disease negativity, and survival compared to standard chemotherapy in this population. In addition, it offers more opportunities to proceed to an allogeneic stem cell transplant in patients who otherwise may not be candidates.
Inotuzumab ozogamicin: a CD22 mAb-drug conjugate for adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia. [2019]Despite improved rates of remission and cure in newly diagnosed adult acute lymphoblastic leukemia (ALL), the prognosis for patients with relapsed or refractory disease remains poor and the 5-year overall survival rate after relapse is under 10%. A recent paradigm shift has focused on the promise of targeted immunotherapy rather than standard chemotherapy, as ALL blast cells express a variety of antigens, and monoclonal antibodies may be developed to identify and destroy the leukemic cells. Inotuzumab ozogamicin is a CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin. CD22 expression is detected on leukemic blasts in over 90% of patients with ALL. Based on promising results from preclinical studies, inotuzumab ozogamicin was tested in Phase 1/2 and Phase 3 clinical trials and it demonstrated improved complete remission rates, progression-free survival and overall survival in relapsed or refractory adult ALL compared to standard therapy. Ongoing studies are evaluating the value of inotuzumab ozogamicin when given in combination with chemotherapy as part of upfront treatment. This review discusses the drug's biochemical properties and mechanism of action, preclinical research outcomes, clinical trial results, adverse events and toxicities, drug approval and ongoing investigations.
Role of inotuzumab ozogamicin in the treatment of relapsed/refractory acute lymphoblastic leukemia. [2019]Inotuzumab ozogamicin is a humanized anti-CD22 monoclonal antibody bound to a toxic natural calicheamicin, which is under investigation for the treatment of relapsed/refractory acute lymphoblastic leukemia. CD22 is commonly expressed in 90-100% of malignant mature B-lymphocyte lineage. The first Phase II study with inotuzumab ozogamicin conducted by Kantarjian et al. gave the opportunity for heavily pretreated patients with acute lymphoblastic leukemia to go for allogeneic stem cell transplant. Inotuzumab is well-tolerated with the exception of veno-occlusive disease. Overall inotuzumab ozogamicin is potentially an encouraging and promising therapy for patients.
Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. [2022]Inotuzumab ozogamicin (InO) is a targeted treatment for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). InO was previously studied in INO-VATE, an international, open-label, randomized phase 3 trial comparing InO against standard of care (SoC). In the present subgroup analysis, we evaluated outcomes in the 55 Asian patients who were randomized in INO-VATE (31 InO and 24 SoC). Complete remission (CR) or CR with incomplete hematologic recovery (CRi) was achieved in 22/31 patients treated with InO versus 5/24 treated with SoC. In the InO arm, more of the patients achieving CR/CRi were minimal residual disease (MRD)-negative (17/22 versus 1/5), and more patients proceeded directly to hematopoietic stem cell transplantation (15/31 versus 3/24). Median overall survival for the respective arms was 5.8 versus 3.9 months (hazard ratio 0.67; 97.5% CI 0.28, 1.62). In the safety analysis (n = 51), the most common adverse events were hematologic. Sinusoidal obstruction syndrome was reported in five InO patients and one SoC patient. In conclusion, Asian patients with relapsed or refractory B-cell ALL experienced improved efficacy with InO versus SoC, with an efficacy and safety profile consistent with results of the overall INO-VATE population.Clinical trial registration: ClinicalTrials.gov identifier: NCT01564784.
Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. [2019]Inotuzumab ozogamicin (InO) has demonstrated efficacy and tolerability in patients aged 18 to 78 years with relapsed/refractory acute lymphoblastic leukemia (ALL) in the INO-VATE trial. This subset analysis compared the efficacy and safety of InO in younger and older patients.