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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03488225
Other study ID # 2015-0922
Secondary ID NCI-2018-0076020
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 28, 2018
Est. completion date April 2, 2020

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event-Free Survival Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse. Start of treatment up to 2 years
Secondary Overall Survival Time from date of treatment start until date of death due to any cause or last Follow-up. Start of treatment up to 2 years
Secondary Participants to Achieve Complete Remission (CR): Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts Start of treatment up to 2 years
Secondary Number of Participants With Minimal Residual Disease (MRD) Negativity MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle. Start of treatment up to 2 years
Secondary Number of Participants With Adverse Events For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting. Start of treatment up to 30 days after last dose received.
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