Chronic Myeloid LeukemiaNCT01169753
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients
A study testing Armodafinil in people with Chronic Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2013
- Phase
- Interventional
- 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 with CML on imatinib, dasatinib or nilotinib (or any other FDA approved tyrosine kinase inhibitor (TKI) for CML)
- Must be >/= 18 years of age
- Must have "fatigue worst" on The Brief Fatigue Inventory > or = 4
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception (refer to protocol for acceptable methods of contraception). Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control. Both men and women must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- Informed consent must be signed
- Patient should have at least a complete cytogenetic response (CCyR) sustained for the last 6 months
Show all 9Show fewer
- Patient should be receiving stable dose of TKI for at least 3 months (i.e. no increase or decrease in dose during this period) and should not have treatment interruptions for more than 7 consecutive days during this time period unless this was exclusively because of fatigue.
- Females must have a negative serum pregnancy test within 48 hours prior to beginning treatment on this trial
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at baseline
Who cannot join
- History of hypersensitivity or allergy to armodafinil, modafinil or any component of the formulation of armodafinil.
- History of or current seizures, glaucoma, major psychiatric diagnosis (psychiatric illness that required hospitalization), narcolepsy or Tourette's syndrome
- History of severe headaches or increased agitation within the last 90 days prior to enrollment
- History of clinically significant uncontrolled pulmonary or cardiac disease (uncontrolled is defined as patients requiring changes in dose and/or start of a new course of treatment in the last 30 days). This may include disease states as congestive heart failure, cardiac arrhythmias, coronary artery disease, chronic obstructive pulmonary disease and asthma)
- Uncontrolled hypertension. Patients that have not been on a stable treatment dose for the past month or have a systolic blood pressure consistently (consistently is defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg
- History of fibromyalgia
Show all 25Show fewer
- History or current abuse of alcohol or drugs
- Moderate to severe depression as measured on the Depression Anxiety Stress Scale (DASS-21)
- If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days
- Currently taking psychostimulants (including appetite suppressants), L-Monoamine oxidases (MAO) inhibitors, anticoagulant therapy, anticonvulsant therapy or current consumption of alcohol within 8 hours of enrollment.
- Current use of corticosteroids, stimulants, or other medications used to improve fatigue symptoms. Topical corticosteroids or occasional, intermittent doses of systemic steroids (e.g., for pre-medications, etc) are allowed
- On clinical trials listing Armodafinil as a prohibited medication within the last 30 days of enrollment
- Use of the following herbals or supplements for fatigue relief within the last 30 days (including dehydroepiandrosterone (DHEA), SAMe, ginkgo, ginseng, green, black or Chinese tea, ephedra (aka-ma-huang), popotillo and Mormon tea
- Any coexisting medical condition or taking any concomitant medication that is likely to interfere with the safe administration of armodafinil
- Hemoglobin < 8 gm/dl at time of enrollment
- Albumin value 50% lower than the lower limit of normal
- Evidence of hepatic impairment (total bilirubin > or = 2.5 times Upper limits of normal (ULN), serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)
- Evidence of renal impairment (serum creatinine > 2.5 times ULN)
- If taking opioids, anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days
- Patients who were ever in blast phase of CML
- Female patients who are pregnant or breastfeeding
- History of mitral valve prolapse documented by cardiac study.
- Patients with history or current suicidal ideation
- Currently taking strong cytochrome P450 3A4 (CYP3A4) inducers (including but not limited to phenobarbital, phenytoin, rifampin,and troglitazone); strong CYP3A4 inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin and grapefruit juice)
- Patients who have been transplanted and are on immunosuppressive therapies that may interfere with TKI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML)
The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
Armodafinil is designed to help promote wakefulness in patients suffering from fatigue.
Study Groups:
If you are found to be eligible to take part in this study, you will take 3 tablets each day during Weeks 1, 2, 4, and 5. You will not take any tablets during Week 3.
You will be randomly assigned (as in the flip of a coin) to a study group. The tablets you receive will depend on which study group you are in. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will take armodafinil during Weeks 1 and 2 and a placebo during Weeks 4 and 5. A placebo is a tablet that looks like the study drug but has no active ingredients.
- If you are in Group 2, you will take a placebo during Weeks 1 and 2 and armodafinil during Weeks 4 and 5.
Neither you nor the study staff will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving at any time.
You will be given a fatigue diary and a drug diary. You will fill out the fatigue diary every day by answering 2 questions about fatigue. You will fill out the drug diary every day by writing when you take the study drug/placebo. You will return any unused drug/placebo at the end of Weeks 2 and 5.
At Week 5, you will be asked if you preferred the first period (Weeks 1 and 2 of the study) or the second period (Weeks 4 and 5 of the study). If your doctor thinks it is in your best interest and you are benefitting at this point, you will be able to continue taking the study drug and you will have additional study visits.
If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. If you take the study drug after Week 5, you will take 3 tablets every day for the rest of the time that you take the study drug.
Study Visits:
At the end of Weeks 1, 3, and 4:
- You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
- You will complete 2 questionnaires about fatigue and activity. It will take about 10 minutes to complete these questionnaires.
- Your blood pressure will be measured (Weeks 1 and 4 only).
At the end of Weeks 2 and 5:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will complete the same questionnaires you completed at screening.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If you were selected for PK testing during screening, you will also have PK blood samples drawn at the end of Week 2 and Week 5.
- You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.
At Weeks 10, 15, 20, and 25:
- You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
- You will complete the 2 questionnaires about fatigue and activity.
- Your blood pressure will be measured.
If you are not scheduled to come to MD Anderson at Weeks 1, 3, 4, 10, 15, 20, and 25, the procedures to be performed at these times can be performed at home. You will be called and asked the questions described in these visits. You will take 2 separate blood pressure measurements 5 minutes apart for each day and report results to the research staff over the telephone. If you choose to take your blood pressure measurements at home, you will be provided with a home blood pressure monitor at screening and taught how to use it. The monitor will be returned to study staff at the end of the study.
Length of Study:
You may continue taking the study drug as part of this study for up to 24 weeks. If you are benefiting after 24 weeks, you may continue taking the study drug off study. If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. You will be taken off study at any time if you have intolerable side effects or if the study doctor thinks it is in your best interest.
End of Treatment:
About 6 months after the end of Week 5, the following tests and procedures will be performed:
- You will complete the same questionnaires you completed at screening.
- You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam, including measurement of your weight and vital signs.
Follow-Up:
The study staff will call you about 30 days after your last dose of study drug and ask about any symptoms or complaints you may have had, as well as about any other drugs you may be taking. This call will last about 10 minutes.
This is an investigational study. Armodafinil is FDA approved and commercially available to help improve wakefulness in adults who experience excessive sleepiness. Its use in cancer-related fatigue is investigational.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Placebo, Armodafinil
- Keywords
- Chronic Myeloid Leukemia, CML, Nuvigil, Armodafinil, Fatigue
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral tablet every morning for 2 weeks
ArmodafinilDrug
Also called Nuvigil
Three 50 mg tablets orally every morning for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients randomized to nonintervention will take a placebo every morning for 2 weeks. Receives: Drug: Placebo |
| Armodafinil | Experimental | Three 50 mg tablets orally every morning for 2 weeks. Receives: Drug: Armodafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With "Fatigue Worst" BFI Score
Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.
Measured: After each 2 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Slow Enrollment
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 Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Carmen Escalante, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169753
- Sponsor's protocol ID
- 2009-0638
- Other IDs
- NCI-2011-00895
- Status last verified
- Nov 2015
- First submitted
- 23 Jul 2010
- Last updated
- 8 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML)
- ClinicalTrials.gov ID
- NCT01169753
- Acronym / sponsor ID
- 2009-0638
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic Myeloid Leukemia, CML, Nuvigil, Armodafinil, Fatigue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Posted 8 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.
Detailed description
The Study Drug:
Armodafinil is designed to help promote wakefulness in patients suffering from fatigue.
Study Groups:
If you are found to be eligible to take part in this study, you will take 3 tablets each day during Weeks 1, 2, 4, and 5. You will not take any tablets during Week 3.
You will be randomly assigned (as in the flip of a coin) to a study group. The tablets you receive will depend on which study group you are in. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will take armodafinil during Weeks 1 and 2 and a placebo during Weeks 4 and 5. A placebo is a tablet that looks like the study drug but has no active ingredients.
- If you are in Group 2, you will take a placebo during Weeks 1 and 2 and armodafinil during Weeks 4 and 5.
Neither you nor the study staff will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving at any time.
You will be given a fatigue diary and a drug diary. You will fill out the fatigue diary every day by answering 2 questions about fatigue. You will fill out the drug diary every day by writing when you take the study drug/placebo. You will return any unused drug/placebo at the end of Weeks 2 and 5.
At Week 5, you will be asked if you preferred the first period (Weeks 1 and 2 of the study) or the second period (Weeks 4 and 5 of the study). If your doctor thinks it is in your best interest and you are benefitting at this point, you will be able to continue taking the study drug and you will have additional study visits.
If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. If you take the study drug after Week 5, you will take 3 tablets every day for the rest of the time that you take the study drug.
Study Visits:
At the end of Weeks 1, 3, and 4:
- You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
- You will complete 2 questionnaires about fatigue and activity. It will take about 10 minutes to complete these questionnaires.
- Your blood pressure will be measured (Weeks 1 and 4 only).
At the end of Weeks 2 and 5:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will complete the same questionnaires you completed at screening.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If you were selected for PK testing during screening, you will also have PK blood samples drawn at the end of Week 2 and Week 5.
- You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.
At Weeks 10, 15, 20, and 25:
- You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
- You will complete the 2 questionnaires about fatigue and activity.
- Your blood pressure will be measured.
If you are not scheduled to come to MD Anderson at Weeks 1, 3, 4, 10, 15, 20, and 25, the procedures to be performed at these times can be performed at home. You will be called and asked the questions described in these visits. You will take 2 separate blood pressure measurements 5 minutes apart for each day and report results to the research staff over the telephone. If you choose to take your blood pressure measurements at home, you will be provided with a home blood pressure monitor at screening and taught how to use it. The monitor will be returned to study staff at the end of the study.
Length of Study:
You may continue taking the study drug as part of this study for up to 24 weeks. If you are benefiting after 24 weeks, you may continue taking the study drug off study. If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. You will be taken off study at any time if you have intolerable side effects or if the study doctor thinks it is in your best interest.
End of Treatment:
About 6 months after the end of Week 5, the following tests and procedures will be performed:
- You will complete the same questionnaires you completed at screening.
- You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam, including measurement of your weight and vital signs.
Follow-Up:
The study staff will call you about 30 days after your last dose of study drug and ask about any symptoms or complaints you may have had, as well as about any other drugs you may be taking. This call will last about 10 minutes.
This is an investigational study. Armodafinil is FDA approved and commercially available to help improve wakefulness in adults who experience excessive sleepiness. Its use in cancer-related fatigue is investigational.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to nonintervention will take a placebo every morning for 2 weeks. |
| Armodafinil | Experimental | Drug: ArmodafinilThree 50 mg tablets orally every morning for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with CML on imatinib, dasatinib or nilotinib (or any other FDA approved tyrosine kinase inhibitor (TKI) for CML)
- Must be >/= 18 years of age
- Must have "fatigue worst" on The Brief Fatigue Inventory > or = 4
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception (refer to protocol for acceptable methods of contraception). Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control. Both men and women must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- Informed consent must be signed
Key exclusion criteria (25 listed)
- History of hypersensitivity or allergy to armodafinil, modafinil or any component of the formulation of armodafinil.
- History of or current seizures, glaucoma, major psychiatric diagnosis (psychiatric illness that required hospitalization), narcolepsy or Tourette's syndrome
- History of severe headaches or increased agitation within the last 90 days prior to enrollment
- History of clinically significant uncontrolled pulmonary or cardiac disease (uncontrolled is defined as patients requiring changes in dose and/or start of a new course of treatment in the last 30 days). This may include disease states as congestive heart failure, cardiac arrhythmias, coronary artery disease, chronic obstructive pulmonary disease and asthma)
- Uncontrolled hypertension. Patients that have not been on a stable treatment dose for the past month or have a systolic blood pressure consistently (consistently is defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg
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 |
|---|---|---|
| PlaceboOral tablet every morning for 2 weeks | Drug | Placebo |
| ArmodafinilAlso: NuvigilThree 50 mg tablets orally every morning for 2 weeks. | Drug | Armodafinil |
Primary outcome
Number of Participants With "Fatigue Worst" BFI Score
Time frame: After each 2 week treatment
Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Chronic Myeloid Leukemia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Carmen Escalante, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armodafinil in people with Chronic Myeloid Leukemia, run by M.D. Anderson Cancer Center 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 9 inclusion and 25 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 8 Dec 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2015). 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?
Number of Participants With "Fatigue Worst" BFI Score (time frame: After each 2 week treatment). 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 8 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.