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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02011945
Other study ID # CA180-373
Secondary ID 2013-002156-33
Status Completed
Phase Phase 1
First received
Last updated
Start date February 7, 2014
Est. completion date December 26, 2018

Study information

Verified date February 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 26, 2018
Est. primary completion date December 26, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

- Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :

- With historically documented Ph+ cells

- =2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML

- Currently progressing, resistance to or with a suboptimal response to their most recent therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1

Exclusion Criteria:

- Blast phase CML

- Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dasatinib

Nivolumab


Locations

Country Name City State
Australia Local Institution Adelaide South Australia
Australia Local Institution Parkville Victoria
Australia Local Institution St Leonards New South Wales
Canada QEII Health Sciences Centre-VG Site Halifax Nova Scotia
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
France Local Institution Bordeaux
Germany Campus Virchow Klinikum Der Charite Berlin
Germany Universitaetsklinikum Bonn Bonn
Germany Universitaetsklinikum Carl Gustav Carus Dresden
Germany Universitaetsklinik Frankfurt Frankfurt am Main
Italy Local Institution Napoli
Italy Local Institution Orbassano
Italy Local Institution Roma
Spain Local Institution Madrid
Spain Local Institution Valencia
United States Winship Cancer Institute Atlanta Georgia
United States Dana Farber Cancer Institute. Boston Massachusetts
United States Ut Southwestern Medical Center At Dallas Dallas Texas
United States The University Of Texas MD Anderson Cancer Center Houston Texas
United States Froedtert Hospital & Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Dose Limiting Toxicities (DLT) DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs:
Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below;
Grade 3 or Grade 4 nonhematologic AE irrespective of duration;
Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention);
Any toxicity managed by discontinuation of nivolumab;
Grade = 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days;
Grade = 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
Week 3 to week 6
Primary Incidence of Adverse Events (AEs) Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
Primary Incidence of Serious Adverse Events (SAEs) Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results. Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
Primary Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology Up to 40 Months
Primary Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests The number of participants with an abnormal Liver function test.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Up to 40 Months
Primary Incidence of Laboratory Abnormalities in Specific Thyroid Tests Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN) Up to 40 Months
Secondary Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as = 3-log reduction in BCR-ABL transcripts or a ratio of = 0.1% on the International Scale (IS).
upto 36 Months
Secondary Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as = 3-log reduction in BCR-ABL transcripts or a ratio of = 0.1% on the International Scale (IS).
upto 36 Months
Secondary Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as = 3-log reduction in BCR-ABL transcripts or a ratio of = 0.1% on the International Scale (IS).
upto 36 Months
Secondary Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as = 4.5-log reduction in BCR-ABL transcripts or a ratio of = 0.00316% on the International Scale (IS).
upto 36 Months
Secondary Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as = 4.5-log reduction in BCR-ABL transcripts or a ratio of = 0.00316% on the International Scale (IS).
upto 36 Months
Secondary Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as = 4.5-log reduction in BCR-ABL transcripts or a ratio of = 0.00316% on the International Scale (IS).
upto 36 Months
Secondary Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. Up to 36 Months
Secondary Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. Up to 36 Months
Secondary Time to Major Molecular Response (MMR) - CML-AP Participants measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. Up to 36 Months
Secondary Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment Up to 36 Months
Secondary Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment Up to 36 Months
Secondary Duration of Major Molecular Response (MMR) - CML-AP Participants will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment Up to 36 Months
Secondary Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. Up to 36 Months
Secondary Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. Up to 36 Months
Secondary Time to Molecular Response 4.5(MR4.5) - CML-AP Participants measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. Up to 36 Months
Secondary Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment Up to 36 Months
Secondary Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment Up to 36 Months
Secondary Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment Up to 36 Months
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