Phase I Study to Assess the Tolerability and Efficacy of Nivolumab in Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02985554|
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: Nivolumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study to Assess the Tolerability and Efficacy of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Patients With Hematologic Malignancies After Allogeneic Stem Cell Transplantation|
|Actual Study Start Date :||March 20, 2017|
|Estimated Primary Completion Date :||March 20, 2020|
|Estimated Study Completion Date :||March 20, 2022|
Nivolumab will be administrated intravenously. Standard dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses.
Nivolumab dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses.
Other Name: Opdivo
- Maximum tolerated dose of Nivolumab [ Time Frame: 24 months ]The maximum tolerated dose (MTD) of Nivolumab in patients with hematologic malignancies after allo-SCT.
- Number of type of adverse events [ Time Frame: 24 months ]To evaluate the toxicities of Nivolumab as maintenance treatment after allogeneic stem cell transplantation (allo-SCT).
- Incidence of non-relapse mortality [ Time Frame: From the date of therapy to the date of non-relapse death, whichever came first, assessed up to 100 months ]
- Time until progression free survival [ Time Frame: From start date of therapy to the first documented disease relapse or death from any cause, whichever may come first, assessed up to 100 months ]
- Time until overall survival [ Time Frame: From start date of therapy to death from any cause, whichever may come first, assessed up to 100 months ]
- Differences in pre- and post treatment levels of T cell subsets and T cell activation status [ Time Frame: 24 months ]To perform an exploratory analysis on the frequencies, absolute numbers and subsets of T cells (including regulatory T cells) in Nivolumab treated patients.
- Differences in pre- and post treatment levels for inspection of changes in "clonality" of T cell repertoire between blood samples [ Time Frame: 24 months ]To perform deep sequencing of TCR-alpha and TCR-beta chains on polyclonal T cells at baseline and at subsequent time points during nivolumab treatment. Changes in levels of responders versus nonresponders will be analyzed using a non-parametric Wilcoxon rank-sum test.
- Quantitative RT-PCR (qPCR) results in peripheral blood and bone marrow samples [ Time Frame: 24 months ]To monitor MRD by WT1 PCR during Nivolumab treatment in AML/MDS patients. The differences will be assessed using a conventional T-test or Wilcoxon rank-sum test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985554
|Contact: Alexis Smallfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Alexis Small 773-702-9440 email@example.com|
|Principal Investigator: Hongtao Liu, MD|
|Principal Investigator:||Hongtao Liu, MD||University of Chicago|