Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Ch… (NCT05303792) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma
United States68 participantsStarted 2023-06-09
Plain-language summary
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
* Research bone marrow or peripheral blood submission
\* This bone marrow or peripheral blood submission is mandatory prior to registration/randomization as baseline for real-time MRD analysis. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible
* REGISTRATION INCLUSION CRITERIA (STEP 1)
* Diagnosis of B-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) per World Health Organization (WHO) 2016 criteria. Patients must have \>= 5% blasts in the bone marrow or blood. Patients with lymphoblastic lymphoma (LBL) without measurable marrow involvement (\>= 5% blasts) are not eligible
\* T-cell ALL/LBL, Philadelphia-chromosome positive B-cell (as determined by fluorescence in situ hybridization \[FISH\], cytogenetics, or reverse transcriptase polymerase chain reaction \[RT-PCR\]), and Burkitt's like leukemia/lymphoma (mature B-ALL) are not eligible
* Must be CD22 positive by local assessment (\>= 20% by immunohistochemistry or flow cytometry). Patients are eligible regardless of CD20 status but CD20 expression should be assessed at diagnosis by flow cytometry or immunohistochemistry
* Patients must have \>= 5% blasts in the bone marrow or blood. Patients with lymphoblastic lymphoma (LBL) without marrow involvemen…
What they're measuring
1
Event-free survival
Timeframe: From randomization to failure to achieve measurable residual disease (MRD)-negative complete response (CR) after two cycles of chemotherapy, relapse, or death from any causes, assessed at 2 months (after 2 cycles of treatment)