At a glance
ClinicalIndex Comparison Record- ✓Age ≥60 years with previously untreated ALL pre-B, Ph- or Ph+ ALL
- ✓Age 18-<60 years unfit with previously untreated ALL pre-B, Ph- or Ph+ ALL, including those who received 1-2 cycles of prior chemotherapy
- ✓Age ≥60 years unfit for intensive chemotherapy with comorbidities and PS ≥1
- ✓Refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma NOS with marrow involvement, any age
- ✕Newly diagnosed Burkitt's leukemia or lymphoma
- ✕T-cell ALL or lymphoblastic lymphoma
- ✕Active heart disease NYHA class >3
- ✕Cardiac ejection fraction <40%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)
In Brief
A Phase 1 clinical trial evaluating Blinatumomab, Cyclophosphamide, and 9 other interventions for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 and 8 related conditions. Currently recruiting, targeting 276 participants across 1 site.
Detailed Summary
This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy 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 together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
Study Details
Timeline
Arms & Interventions
See Detailed Description Arm I
See Detailed Description Arm II
See Detailed Description Arm III
Interventions
Given CIVI
Given IV
Given IT and IV
Given IV or PO
Given IV
Correlative studies
Given PO
Given IT, IV, and PO
Given PO
Given IV
Given IV