B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1Phase 1NCT02819804
Nivolumab and Dasatinib in Treating Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
A Phase 1 study testing Dasatinib, Laboratory Biomarker Analysis and Nivolumab in people with B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 and Recurrent Adult Acute Lymphoblastic Leukemia, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the acceptable upper limit dose of nivolumab in combination with dasatinib that may be given to patients with relapsed/refractory philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- Dasatinib, Laboratory Biomarker Analysis and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2017to 30 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis of Ph+ ALL
- Detection of one of the following must be present:
- t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics
- Breakpoint cluster region (BCR)-Abelson (ABL) positive status by molecular analysis with qualitative polymerase chain reaction (PCR) or fluorescence in situ hybridization (FISH)
- Patients must have primary refractory ALL based on failure to achieve a hematologic or molecular remission after induction therapy with dasatinib and steroids or dasatinib and chemotherapy, or have relapsed after treatment with a tyrosine kinase inhibitor with or without chemotherapy
- Note: Prior course of dasatinib and steroid induction therapy should have included dasatinib 140mg PO daily on days 1-84 and prednisone 60mg/m^2 (capped at 120mg, or equivalent steroid dose) on days 1-28; if patients were unable to tolerate full steroid dose during induction therapy they will still be eligible
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- Note: Patients with refractory or relapsed disease in the central nervous system will be eligible
- Prior chemotherapy or tyrosine kinase inhibitor (TKI) treatment, aside from dasatinib, must be >= 7 days before first investigational agent dose
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients must have adequate organ and bone marrow function prior to registration, as defined below:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x institutional upper limit of normal (IULN)
- Total bilirubin < 2.0 x IULN (unless Gilbert syndrome has been diagnosed); if leukemia infiltration of the liver is suspected to be causing liver function abnormalities the patient will still be eligible with principal investigator (PI) approval
- Creatinine < 2 x IULN
- Creatinine clearance > 40 mL/min (measured by Cockroft-Gault)
- Females of child-bearing potential (FOCBP) must have a negative pregnancy test within 7 days of registration
- Note: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- Women must not be breastfeeding at the time of study registration
- Women and men of reproductive potential should agree to use two effective means of birth control
- For women, contraception should continue for 23 weeks after the last dose of nivolumab and 12 weeks after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body
- For men, contraception should continue for 31 weeks after nivolumab and 12 weeks after dasatinib
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Who cannot join
- Patients may not be receiving any other investigational agents within 5 half-lives of the drug (if known); if the half-life is not known, investigational agents should not be taken within two weeks
- Patients are not eligible if they have an intolerance to most recent prior TKI (other than dasatinib) at the lowest possible effective dose, defined as a grade >= 3 toxicity considered at least possibly related to that TKI; patients are also excluded if they are intolerant or allergic to dasatinib and discontinued prior therapy due to a >= grade 2 treatment related adverse event
- Patients must not have a history of a grade 4 anaphylactic reaction to monoclonal antibody therapy or known hypersensitivity reactions to drugs formulated with polysorbate 90
- Patients must not have had any prior therapy with an anti-PD-1, anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-cluster of differentiation (CD)137 or anti-cytotoxic t-lymphocyte-associated protein 4 ligand (CTLA-4) antibody (or any antibody or drug specifically targeting T-cell costimulation or checkpoint pathways; for questions or uncertainties, please contact the PI or quality assurance manager (QAM)
- Patients who have had allogeneic hematopoietic stem cell transplant (HSCT) are not eligible if they meet any of the following:
- transplant is within 2 months from cycle 1, day 1 (C1D1)
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- Has clinically significant graft-versus-host disease requiring treatment
- Has >= grade 3 persistent non-hematological toxicity related to the transplant
- Concomitant use of strong inhibitors of the cytochrome p450, family 3, subfamily a, polypeptide 4 (CYP3A4) isoenzyme is not permitted; must have wash-out period of 5 times the half-life of the compound before first dasatinib dose
- Concomitant use of QT prolonging agents strongly associated with torsades de pointes is not permitted
- Patients who have a known dasatinib-resistant ABL-kinase mutation such as T315I are not eligible; for confirmation, please contact PI
- Patients who have any serious or uncontrolled medical disorder that would impair the ability of the subject to receive protocol therapy are not eligible; these include, but are not limited to:
- Active infection that is not well controlled
- Known pleural or pericardial effusion at baseline
- Clinically significant gastrointestinal disease or digestive dysfunction compromising absorption of dasatinib
- Pulmonary arterial hypertension
- Uncontrolled or significant cardiovascular disease, including:
- Myocardial infarction within 6 months of enrollment date
- Uncontrolled angina or congestive heart failure within 3 months of enrollment date
- Left ventricular ejection fraction (LVEF) < 40%
- Significant cardiac conduction abnormality, including:
- History of clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- History of second or third degree heart block (except for second degree type 1)
- Corrected QT (QTc) interval > 500 msec, unless a cardiac pacemaker is present
- Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancers, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast
- Subjects with active, known or suspected autoimmune disease; (Note: Subjects with vitiligo, type I diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll)
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Female patients who are pregnant or nursing are not eligible
- Patients are not eligible if they have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute infection; Note: Patients with evidence of chronic hepatitis B infection will be allowed to enroll if on appropriate suppressive medications under the direction of a hepatologist and with PI approval
- Patients who are known to be positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are not eligible
- Patients must not have live vaccine therapies for prevention of infectious diseases within 28 days of first nivolumab dose
- Patients who are unable to swallow oral medication are not eligible
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:
- Immune related neurologic disease
- Multiple sclerosis
- Autoimmune (demyelinating) neuropathy
- Guillain-Barre syndrome
- Myasthenia gravis
- Systemic autoimmune disease such as systemic lupus erythematosus (SLE)
- Connective tissue diseases
- Scleroderma
- Inflammatory bowel disease (IBD)
- Crohn's
- Ulcerative colitis
- Patients with a history of toxic epidermal necrolysis (TEN)
- Stevens-Johnson syndrome
- Anti-phospholipid syndrome NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Study of Nivolumab and Dasatinib in Patients With Relapsed/Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
The purpose of this research study is to determine the acceptable upper limit dose of nivolumab in combination with dasatinib that may be given to patients with relapsed/refractory philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has not yet been investigated in Ph+ ALL. Dasatinib is currently FDA approved for the treatment of Ph+ ALL, but has not yet been investigated in combination with nivolumab for this disease. There is evidence that dasatinib not only blocks the Philadelphia chromosome or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) mutation, but also increases the activity of cells in your immune system. Nivolumab increases T cells in your immune system, which allows your immune system to attack the cancer. We think the combination of these drugs will be more effective against your leukemia than either drug used alone.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib in patients with relapsed/refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
SECONDARY OBJECTIVES:
- To evaluate the toxicities and safety profile of nivolumab and dasatinib in patients with relapsed/refractory Ph+ ALL.
II. To determine the rate of complete hematologic remission (CR) after three cycles of nivolumab and dasatinib.
III. To determine the rate of molecular remission after three cycles of nivolumab and dasatinib.
IV. To study the pharmacokinetics of nivolumab and dasatinib. V. To evaluate programmed cell death 1 (PD1) expression levels and saturation in the peripheral blood and bone marrow.
VI. To measure peripheral T-cell levels and activation in response to treatment.
TERTIARY OBJECTIVES:
- To evaluate the 30 day mortality rate, overall survival (OS), progression free survival (PFS), and duration of remission (DOR) one year after treatment with nivolumab when given in combination with dasatinib in patients with relapsed/refractory Ph+ ALL.
II. To compare the OS between patients who receive a hematopoietic stem cell transplant and those who receive no further therapy following remission.
III. To evaluate for resistance mutations at the time of disease progression.
OUTLINE:
Patients receive dasatinib orally (PO) once daily (QD ) on days 1-28 and nivolumab intravenously (IV) over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or withdrawal from the study for other reasons.
After completion of study treatment, patients are followed up at 30 days and then monthly for up to 1 year.
- Conditions
- B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Adult Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia
- Being tested
- Dasatinib, Laboratory Biomarker Analysis, Nivolumab, Pharmacological Study
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called BMS-354825, Sprycel
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
NivolumabBiological
Also called BMS-936558, MDX-1106, NIVO, ONO-4538
Given IV
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (dasatinib, nivolumab) | Experimental | Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Dasatinib; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
Determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib, the MTD will be defined as the highest dose level at which ≤ 1 DLT occurs and will be assessed by the Common Terminology Criteria for Adverse Events version 4.03.
Measured: Up to 28 days
Secondary outcomes (8)
Incidence of Adverse Events
To evaluate the toxicity and safety of nivolumab and dasatinib in patients with relapsed/refractory Ph+ ALL. Adverse events will be assessed by number, frequency, and severity and will be graded according to the NCI's common terminology criteria, version 4.03.
Measured: Up to 28-days after the last dose
Rate of Complete Hematologic Remission (CR)
Determine the rate of complete hematologic remission (CR) after three cycles of nivolumab and dasatinib
Measured: At 84 days (3 cycles)
Rate of Molecular Remission
Determine the rate of molecular remission after three cycles of nivolumab and dasatinib.
Measured: At 84 days (3 cycles)
Serum Level of Dasatinib
The serum level of dasatinib will be measured at 24 hours after the start of cycle 1 and on days 8, 15, and 22 prior to treatment during cycle 1.
Measured: 24 hours after the start of cycle 1 and days 8, 15, and 22 prior to treatment during cycle 1
Serum Level of Nivolumab
The serum level of nivolumab will be measured on days 8, 15, and 22 prior to treatment during cycle 1.
Measured: Days 8, 15, and 22 prior to treatment during cycle 1
PD1 Expression Levels and Saturation Assessed in the Peripheral Blood
Peripheral blood will be evaluated to measure PD1 expression levels and saturation.
Measured: Baseline to 28-days after the last dose
PD1 Expression Levels and Saturation in Bone Marrow
Bone marrow will be assessed to measure PD1 expression levels and saturation.
Measured: Baseline to 28-days after the last dose
Peripheral T-cell Levels and Activation in Response to Treatment
T-cell levels and activation will be measured in the peripheral blood after treatment.
Measured: At cycle 1 days: 1, 2, 8, 15, & 22 prior to dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start17 Aug 2017
- Primary completion27 Aug 2017
- Study completion30 Aug 2018
Why it stopped: Due to funding and accrual issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shira Dinner, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819804
- Sponsor's protocol ID
- NU 15H13
- Other IDs
- STU00202846, NU 15H13, P30CA060553, NCI-2016-00711
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 2016
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Nivolumab and Dasatinib in Patients With Relapsed/Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
- ClinicalTrials.gov ID
- NCT02819804
- Acronym / sponsor ID
- NU 15H13
- Conditions
- B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Adult Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to funding and accrual issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 27 Aug 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the acceptable upper limit dose of nivolumab in combination with dasatinib that may be given to patients with relapsed/refractory philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has not yet been investigated in Ph+ ALL. Dasatinib is currently FDA approved for the treatment of Ph+ ALL, but has not yet been investigated in combination with nivolumab for this disease. There is evidence that dasatinib not only blocks the Philadelphia chromosome or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) mutation, but also increases the activity of cells in your immune system. Nivolumab increases T cells in your immune system, which allows your immune system to attack the cancer. We think the combination of these drugs will be more effective against your leukemia than either drug used alone.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib in patients with relapsed/refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
SECONDARY OBJECTIVES:
- To evaluate the toxicities and safety profile of nivolumab and dasatinib in patients with relapsed/refractory Ph+ ALL.
II. To determine the rate of complete hematologic remission (CR) after three cycles of nivolumab and dasatinib.
III. To determine the rate of molecular remission after three cycles of nivolumab and dasatinib.
IV. To study the pharmacokinetics of nivolumab and dasatinib. V. To evaluate programmed cell death 1 (PD1) expression levels and saturation in the peripheral blood and bone marrow.
VI. To measure peripheral T-cell levels and activation in response to treatment.
TERTIARY OBJECTIVES:
- To evaluate the 30 day mortality rate, overall survival (OS), progression free survival (PFS), and duration of remission (DOR) one year after treatment with nivolumab when given in combination with dasatinib in patients with relapsed/refractory Ph+ ALL.
II. To compare the OS between patients who receive a hematopoietic stem cell transplant and those who receive no further therapy following remission.
III. To evaluate for resistance mutations at the time of disease progression.
OUTLINE:
Patients receive dasatinib orally (PO) once daily (QD ) on days 1-28 and nivolumab intravenously (IV) over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or withdrawal from the study for other reasons.
After completion of study treatment, patients are followed up at 30 days and then monthly for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (dasatinib, nivolumab) | Experimental | Drug: Dasatinib, Other: Laboratory Biomarker Analysis, Biological: Nivolumab, Other: Pharmacological StudyPatients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients must have a histologically confirmed diagnosis of Ph+ ALL
- Detection of one of the following must be present:
- Patients must have primary refractory ALL based on failure to achieve a hematologic or molecular remission after induction therapy with dasatinib and steroids or dasatinib and chemotherapy, or have relapsed after treatment with a tyrosine kinase inhibitor with or without chemotherapy
- Prior chemotherapy or tyrosine kinase inhibitor (TKI) treatment, aside from dasatinib, must be >= 7 days before first investigational agent dose
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (48 listed)
- Patients may not be receiving any other investigational agents within 5 half-lives of the drug (if known); if the half-life is not known, investigational agents should not be taken within two weeks
- Patients are not eligible if they have an intolerance to most recent prior TKI (other than dasatinib) at the lowest possible effective dose, defined as a grade >= 3 toxicity considered at least possibly related to that TKI; patients are also excluded if they are intolerant or allergic to dasatinib and discontinued prior therapy due to a >= grade 2 treatment related adverse event
- Patients must not have a history of a grade 4 anaphylactic reaction to monoclonal antibody therapy or known hypersensitivity reactions to drugs formulated with polysorbate 90
- Patients must not have had any prior therapy with an anti-PD-1, anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-cluster of differentiation (CD)137 or anti-cytotoxic t-lymphocyte-associated protein 4 ligand (CTLA-4) antibody (or any antibody or drug specifically targeting T-cell costimulation or checkpoint pathways; for questions or uncertainties, please contact the PI or quality assurance manager (QAM)
- Patients who have had allogeneic hematopoietic stem cell transplant (HSCT) are not eligible if they meet any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: BMS-354825, SprycelGiven PO | Drug | Treatment (dasatinib, nivolumab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (dasatinib, nivolumab) |
| NivolumabAlso: BMS-936558, MDX-1106, NIVO, ONO-4538Given IV | Biological | Treatment (dasatinib, nivolumab) |
| Pharmacological StudyCorrelative studies | Other | Treatment (dasatinib, nivolumab) |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: Up to 28 days
Determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib, the MTD will be defined as the highest dose level at which ≤ 1 DLT occurs and will be assessed by the Common Terminology Criteria for Adverse Events version 4.03.
8 secondary outcomes
Incidence of Adverse Events
Time frame: Up to 28-days after the last dose
Rate of Complete Hematologic Remission (CR)
Time frame: At 84 days (3 cycles)
Rate of Molecular Remission
Time frame: At 84 days (3 cycles)
Serum Level of Dasatinib
Time frame: 24 hours after the start of cycle 1 and days 8, 15, and 22 prior to treatment during cycle 1
Serum Level of Nivolumab
Time frame: Days 8, 15, and 22 prior to treatment during cycle 1
PD1 Expression Levels and Saturation Assessed in the Peripheral Blood
Time frame: Baseline to 28-days after the last dose
PD1 Expression Levels and Saturation in Bone Marrow
Time frame: Baseline to 28-days after the last dose
Peripheral T-cell Levels and Activation in Response to Treatment
Time frame: At cycle 1 days: 1, 2, 8, 15, & 22 prior to dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shira Dinner, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib, Laboratory Biomarker Analysis and Nivolumab in people with B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 and Recurrent Adult Acute Lymphoblastic Leukemia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.