Acute Myeloid Leukemia (AML)Phase 2NCT02351037
Study of Ibrutinib in Subjects With Acute Myeloid Leukemia
A Phase 2 study testing Ibrutinib, Ibrutinib + LD-AraC and Ibrutinib+Azacitidine in people with Acute Myeloid Leukemia (AML), run by Pharmacyclics LLC. at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Ibrutinib, Ibrutinib + LD-AraC and Ibrutinib+Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2015to Apr 2017
- Phase
- Phase 2
- 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
- Male and female ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Subjects with pathologically documented AML that has failed standard treatment, or subjects without prior therapy who refuse standard treatment options
- Bone marrow aspirate/biopsy results showing >5% blasts
- WBC count <25,000 cells/mm3 (25 x 109/L)
- Platelet count >10,000 cells/mm3 (10 x 109/L)
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- Adequate hepatic and renal function defined as:
- For Cohorts 1 and 2: serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤3.0 x upper limit of normal (ULN); for Cohort 3: ALT ≤2.5 or AST ≤2.5 ULN.
- Serum creatinine ≤2 mg/dL or Estimated Creatinine Clearance ≥30 mL/min (Cockcroft-Gault).
- Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).
- PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN (When treated with warfarin or other vitamin K antagonists, then INR ≤3.0).
- Female subjects who are of non-reproductive potential (Female subjects of reproductive potential must have a negative serum pregnancy test upon study entry).
- Male and female subjects of reproductive potential agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug.
Who cannot join
- Acute promyelocytic leukemia (French-American-British Class M3 AML).
- Known active central nervous system (CNS) leukemia.
- Known active systemic infection (Grade ≥2).
- Active bleeding disorders or clinical signs of bleeding (Grade ≥2).
- Prior bone marrow transplant that requires immunosuppressant therapy or presents with graft vs host disease (GVHD).
- History of other malignancies, except:
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- Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and with low risk of recurrence by treating physician.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Prior treatment with a BTK inhibitor.
- For Cohort 3 subjects, prior treatment with hypomethylating agents (eg, azacitidine, decitabine)
- Anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug.
- Subject has received a monoclonal antibody for anticancer intent within 8 weeks prior to the first dose of study drug.
- Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
- Recent infection requiring intravenous (IV) systemic treatment that was completed ≤14 days before the first dose of study drug.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), Grade 0 or 1, unless otherwise defined in the inclusion/exclusion criteria with the exception of alopecia.
- Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
- Major surgery within 4 weeks of first dose of study drug.
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
- Concomitant use of warfarin or other Vitamin K antagonists.
- Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
- Currently active, clinically significant hepatic impairment (≥ moderate hepatic impairment according to the Child Pugh classification).
- Lactating or pregnant.
- Unwilling or unable to participate in all required study evaluations and procedures.
- Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Roswell Park Cancer Institute
Buffalo, New York, 14263
The University of Chicago Medical Center
Chicago, Illinois, 60637
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
UC Davis Medical Center
Sacramento, California, 95817
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Montefiore Einstein Center for Cancer Research
The Bronx, New York, 10461
About this study
Official title: A Multicenter Open-Label Phase 2a Study of Ibrutinib Monotherapy or in Combination With Either Cytarabine or Azacitidine in Subjects With Acute Myeloid Leukemia
The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Ibrutinib, Ibrutinib + LD-AraC, Ibrutinib+Azacitidine
- Keywords
- Acute Myeloid Leukemia, AML, Ibrutinib, Cytarabine, LD-AraC, Azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called Cohort 1
Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
Ibrutinib + LD-AraCDrug
Also called Cohort 2
Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Ibrutinib+AzacitidineDrug
Also called Cohort 3
Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib Monotherapy Cohort | Experimental | Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis. Receives: Drug: Ibrutinib |
| Ibrutinib + LD-AraC Combination Cohort | Experimental | Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle. Receives: Drug: Ibrutinib + LD-AraC |
| Ibrutinib+Azacitidine Combination Cohort | Experimental | Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles). Receives: Drug: Ibrutinib+Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines
Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/µL]) or thrombocytopenia (<100 x 109/L [100 000/µL]) ; Morphologic leukemia-free state, Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts > 5%; or reappearance of blasts in the blood; or development of extramedullary disease.
Measured: When the last subject enrolled completes approximately 12 months of treatment.
Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine
Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings.
Measured: Up to 30 days following the last dose of study drug.
Secondary outcomes (2)
Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS)
To evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).
Measured: When the last subject enrolled completes approximately 12 months of treatment
Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR)
To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).
Measured: When the last subject enrolled completes approximately 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Study data do not support development in AML.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Cortes, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351037
- Sponsor's protocol ID
- PCYC-1131-CA
- Status last verified
- Jul 2018
- First submitted
- 16 Jan 2015
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wilken R, Li CS, Sharon VR, Kim K, Patel FB, Patel F, Maverakis E. Topical clobetasol for the treatment of toxic epidermal necrolysis: study protocol for a randomized controlled trial. Trials. 2015 Aug 22;16:374. doi: 10.1186/s13063-015-0879-7.
PubMed 26297574
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Phase 2a Study of Ibrutinib Monotherapy or in Combination With Either Cytarabine or Azacitidine in Subjects With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02351037
- Acronym / sponsor ID
- PCYC-1131-CA
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia, AML, Ibrutinib, Cytarabine, LD-AraC, Azacitidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study data do not support development in AML.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 14 Aug 2018
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 study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib Monotherapy Cohort | Experimental | Drug: IbrutinibUp to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis. |
| Ibrutinib + LD-AraC Combination Cohort | Experimental | Drug: Ibrutinib + LD-AraCUp to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle. |
| Ibrutinib+Azacitidine Combination Cohort | Experimental | Drug: Ibrutinib+AzacitidineUp to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Subjects with pathologically documented AML that has failed standard treatment, or subjects without prior therapy who refuse standard treatment options
- Bone marrow aspirate/biopsy results showing >5% blasts
- WBC count <25,000 cells/mm3 (25 x 109/L)
Key exclusion criteria (29 listed)
- Acute promyelocytic leukemia (French-American-British Class M3 AML).
- Known active central nervous system (CNS) leukemia.
- Known active systemic infection (Grade ≥2).
- Active bleeding disorders or clinical signs of bleeding (Grade ≥2).
- Prior bone marrow transplant that requires immunosuppressant therapy or presents with graft vs host disease (GVHD).
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 |
|---|---|---|
| IbrutinibAlso: Cohort 1Subjects will receive ibrutinib 560 mg once daily on a continuing basis. | Drug | Ibrutinib Monotherapy Cohort |
| Ibrutinib + LD-AraCAlso: Cohort 2Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle. | Drug | Ibrutinib + LD-AraC Combination Cohort |
| Ibrutinib+AzacitidineAlso: Cohort 3Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles). | Drug | Ibrutinib+Azacitidine Combination Cohort |
Primary outcome
Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines
Time frame: When the last subject enrolled completes approximately 12 months of treatment.
Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/µL]) or thrombocytopenia (<100 x 109/L [100 000/µL]) ; Morphologic leukemia-free state, Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts > 5%; or reappearance of blasts in the blood; or development of extramedullary disease.
Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine
Time frame: Up to 30 days following the last dose of study drug.
Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings.
2 secondary outcomes
Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS)
Time frame: When the last subject enrolled completes approximately 12 months of treatment
Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR)
Time frame: When the last subject enrolled completes approximately 12 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26297574Wilken R, Li CS, Sharon VR, Kim K, Patel FB, Patel F, Maverakis E. Topical clobetasol for the treatment of toxic epidermal necrolysis: study protocol for a randomized controlled trial. Trials. 2015 Aug 22;16:374. doi: 10.1186/s13063-015-0879-7.
- Individual participant dataSharing planned: No
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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.
Jorge Cortes, MD principal investigator
M.D. Anderson Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib, Ibrutinib + LD-AraC and Ibrutinib+Azacitidine in people with Acute Myeloid Leukemia (AML), run by Pharmacyclics LLC. at 9 sites 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 13 inclusion and 29 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Aug 2018). 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?
Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines (time frame: When the last subject enrolled completes approximately 12 months of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351037, which also lists 1 linked publication.
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 14 Aug 2018.