LeukemiaPhase 2NCT01392170
Pegasys in Patients With Chronic Myeloid Leukemia (CML)
A Phase 2 study testing PEG-IFNá-2a in people with 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 adding pegylated interferon-alfa 2a (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of this treatment combination will also be studied. Pegasys is a form of the drug interferon. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- PEG-IFNá-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
- Patients are receiving an FDA-approved TKI for the management of CML.
- Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.
- Patients must be in complete cytogenetic remission.
- Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria: 1. The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. The patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
- Patients must not have had a known continuous interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
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- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatinine </= 1.5x ULN, and serum glutamate pyruvate transaminase (sGPT) or serum glutamate oxaloacetate transaminase (sGOT) </= 2.5x ULN.
- Men and women of childbearing potential should practice effective methods of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment.
Who cannot join
- Patients receiving any non-FDA approved TKI.
- Patients who are pregnant or breast-feeding.
- Patients with clinically significant heart disease (NYHA Class III or IV).
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: Phase II Study of Pegylated Ifná-2a (Pegasys) in Patients With Chronic Myeloid Leukemia Who Have Minimal Residual Disease While Receiving Therapy With Tyrosine Kinase Inhibitors
The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of this treatment combination will also be studied.
Pegasys is a form of the drug interferon. It is designed to help the body's immune system to fight infections. It may also affect the body's response to cancer.
Read more
A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from growing, and may cause them to die.
You are already receiving a TKI. This consent form will describe the administration of Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys, and any risks/benefits there may be from receiving Pegasys.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive Pegasys through a needle under the skin 1 time each week while you are on study. You will be taught how to use the study drug at the first visit and will administer it to yourself at all future doses.
You will continue receiving the TKI you are already taking at the dose and frequency you have been receiving it when you began taking part in this study.
Study Visits:
At every study visit, you will be asked about any side effects you may have had and to list any drugs you may be taking.
Every 1-2 weeks for 8 weeks, then every 6-8 weeks after that, blood (about 1-2 teaspoons) will be drawn for routine tests.
Every 3 months for 6 months, then every 6-12 months after that, you will have a complete physical exam, including measurement of your vital signs.
Every 3-6 months for 1 year, you will have a bone marrow aspirate to check the status of the disease and to check for changes in your chromosomes.
Every 3-6 months for 1 year, then every 6-12 months after that, blood (about 1 teaspoon) will be drawn to check the levels of leukemia in the blood.
Length of Study:
You may continue taking Pegasys for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Pegasys is FDA approved and commercially available for the treatment of CML. TKIs (imatinib, nilotinib, and dasatinib) are FDA approved and commercially available for the treatment of CML. The combination of these drugs to treat CML is investigational.
Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- PEG-IFNá-2a
- Keywords
- Leukemia, Chronic Myeloid Leukemia, CML, Tyrosine Kinase Inhibitors, TKI, Complete cytogenetic remission, CCyR, Minimal residual disease, MRD, PEG-IFNa-2a, Pegasys, Peginterferon Alpha-2a, Philadelphia chromosome (Ph)-positive, BCR-ABL1-positive
- Medical subject headings
- Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasm, Residual, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFNá-2aDrug
Also called Pegasys, Peginterferon Alpha-2a
45 mcg given subcutaneously as a single weekly dose for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFNá-2a | Experimental | PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose. Receives: Drug: PEG-IFNá-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)
Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).
Measured: 12 months from start of treatment with PEG-IFNá-2a
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Slow Accrual
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfonso Quintas-Cardama, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392170
- Sponsor's protocol ID
- 2011-0184
- Other IDs
- NCI-2011-01465
- Status last verified
- Apr 2015
- First submitted
- 8 Jul 2011
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pegylated Ifná-2a (Pegasys) in Patients With Chronic Myeloid Leukemia Who Have Minimal Residual Disease While Receiving Therapy With Tyrosine Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT01392170
- Acronym / sponsor ID
- 2011-0184
- Conditions
- Leukemia
- Keywords
- Leukemia, Chronic Myeloid Leukemia, CML, Tyrosine Kinase Inhibitors, TKI, Complete cytogenetic remission, CCyR, Minimal residual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Posted 14 Apr 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 adding pegylated interferon-alfa 2a (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of this treatment combination will also be studied.
Pegasys is a form of the drug interferon. It is designed to help the body's immune system to fight infections. It may also affect the body's response to cancer.
A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from growing, and may cause them to die.
You are already receiving a TKI. This consent form will describe the administration of Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys, and any risks/benefits there may be from receiving Pegasys.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive Pegasys through a needle under the skin 1 time each week while you are on study. You will be taught how to use the study drug at the first visit and will administer it to yourself at all future doses.
You will continue receiving the TKI you are already taking at the dose and frequency you have been receiving it when you began taking part in this study.
Study Visits:
At every study visit, you will be asked about any side effects you may have had and to list any drugs you may be taking.
Every 1-2 weeks for 8 weeks, then every 6-8 weeks after that, blood (about 1-2 teaspoons) will be drawn for routine tests.
Every 3 months for 6 months, then every 6-12 months after that, you will have a complete physical exam, including measurement of your vital signs.
Every 3-6 months for 1 year, you will have a bone marrow aspirate to check the status of the disease and to check for changes in your chromosomes.
Every 3-6 months for 1 year, then every 6-12 months after that, blood (about 1 teaspoon) will be drawn to check the levels of leukemia in the blood.
Length of Study:
You may continue taking Pegasys for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Pegasys is FDA approved and commercially available for the treatment of CML. TKIs (imatinib, nilotinib, and dasatinib) are FDA approved and commercially available for the treatment of CML. The combination of these drugs to treat CML is investigational.
Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-IFNá-2a | Experimental | Drug: PEG-IFNá-2aPEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
- Patients are receiving an FDA-approved TKI for the management of CML.
- Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.
- Patients must be in complete cytogenetic remission.
- Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria: 1. The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. The patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
Key exclusion criteria (3 listed)
- Patients receiving any non-FDA approved TKI.
- Patients who are pregnant or breast-feeding.
- Patients with clinically significant heart disease (NYHA Class III or IV).
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 |
|---|---|---|
| PEG-IFNá-2aAlso: Pegasys, Peginterferon Alpha-2a45 mcg given subcutaneously as a single weekly dose for 24 months. | Drug | PEG-IFNá-2a |
Primary outcome
Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)
Time frame: 12 months from start of treatment with PEG-IFNá-2a
Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Alfonso Quintas-Cardama, MD principal investigator
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 Phase 2 study testing PEG-IFNá-2a in people with 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 10 inclusion and 3 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 4 May 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. 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 Apr 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 Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR) (time frame: 12 months from start of treatment with PEG-IFNá-2a). 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 4 May 2015.