Chronic Myeloid LeukemiaPhase 2NCT00573378
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
A Phase 2 study testing PEG-IFN-a2b in people with Chronic Myeloid Leukemia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, [IFN]) for 2 years, subsequently… 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?
- PEG-IFN-a2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2015
- 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
- Patients must have a diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase by having met all of the following criteria at the time of their initial diagnosis:
- Cytogenetic confirmation of Philadelphia chromosome or variants of the t(9;22) translocations. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
- Peripheral blood or bone marrow blast count < 10%.
- Peripheral blood basophil count < 20%.
- Platelet count ≥ 100,000 x 109/L.
- If the peripheral blood counts are unavailable from the time of their original diagnosis, but there is no evidence of accelerated- or blast-phase disease from prior clinical or other medical records, then they will be allowed to participate.
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- Patients must be eighteen years of age or older.
- Patients must be actively receiving treatment for their CML with a a tyrosine kinase inhibitor, either imatinib or nilotinib.
- Patients may be receiving imatinib mesylate. Patients must be on imatinib mesylate for a minimum of 2 years, and be on a stable dose for at least one consecutive year leading up to enrollment.
- Patients may be receiving nilotinib (Tasigna) as frontline therapy or as second line therapy if the reason for the switch from imatinib to nilotinib was intolerance to imatinib. Patients cannot have been switched from imatinib to nilotinib because of a concern or demonstration for resistance to frontline imatinib. Patients must be on nilotinib for a minimum of 2 years, and be on a stable does for at least one consecutive year leading up to enrollment.
- Patients must have an ongoing complete hematologic response (CHR) on a a TKI (imatinib or nilotinib), defined as follows:
- WBC ≤ 10 x 109/L.
- Platelet count < 450,000 x 109/L.
- No blasts or promyelocytes in peripheral blood.
- No evidence of disease-related symptoms and extramedullary disease, including the liver and spleen.
- Patients must have a complete cytogenetic response (CCyR) on a TKI (imatinib or nilotinib) for a minimum of 1 year leading up to enrollment. Complete cytogenetic response is defined as 0% Ph+ cells in metaphase, in the bone marrow and/or a negative peripheral blood FISH analysis for the Bcr-Abl gene fusion, and an ongoing CCyR must be confirmed by bone marrow aspirate cytogenetics and/or peripheral blood FISH for Bcr-Abl within 4 weeks of starting treatment.
- Patients may have a negative quantitative RT-PCR (qPCR) for BCR-ABL at the time of enrollment, but if the qPCR is positive, patients cannot have greater than 1% bcr-ABl / Abl /ABL transcript, present in 2 consecutive qPCR analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment.
- Patients must have an ECOG performance status of 0-2 (Appendix 13.1).
- All patients must be informed of the investigational nature of this study and standard alternative therapy. All patients must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Patients who have had prior progression of their CML to accelerated phase or blast crisis.
- Patients who have previously undergone hematopoietic stem cell transplantation.
- Patients who have previously been treated with interferon-α.
- Patients with an absolute neutrophil count (ANC) < 1500/mm3 and/or a platelet count < 100,000/mm3.
- Patients with serum bilirubin, SGOT[AST], SGPT[ALT], or serum creatinine > 1.5 x the upper limit of normal (ULN).
- Patients with an INR or PTT > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants.
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- Patients with uncontrolled medical diseases such as diabetes mellitus, neuropsychiatric disorders, infection, angina, severe hypertension, pulmonary disease (chronic obstructive pulmonary disease [COPD] with hypoxemia), major organ malfunction (liver, kidney) or class III or IV cardiac disease as defined by the New York Heart Association Criteria.
- Patients who are (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Patients with a history of another active malignancy within the last five years, which required treatment with chemotherapy, hormonal therapy, or radiation therapy. Exceptions to this rule include basal cell and squamous cell skin carcinomas or cervical carcinoma in situ.
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combination of Imatinib or Nilotinib Together With Pegylated Interferon-α2b in Chronic-Phase Chronic Myeloid Leukemia: A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, [IFN]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- PEG-IFN-a2b
- Keywords
- CML
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFN-a2bDrug
Also called Pegintron®
Patients will receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week. Patients and/or caregivers identified by the patient will be taught how to perform subcutaneous injections of the PEG-IFN-α2b by trained nurses in the chemotherapy infusion center at the University of Michigan Comprehensive Cancer Center. Those patients who do not feel comfortable receiving the injections outside of the cancer center, or are deemed unreliable in administering injections per the training nurse, will return to the cancer center infusion room on a weekly basis to receive subsequent injections.
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN-a2b | Experimental | Not described Receives: Drug: PEG-IFN-a2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free Survival (RFS) Rate 1 Year After Discontinuation of the TKI and IFN
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, [IFN]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
Measured: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
Secondary outcomes (1)
Quantitative Reverse Transcriptase-polymerase Chain Reaction (qRT-PCR) for the Bcr-Abl Transcript.
To determine whether the addition of PEG-IFN-a2b to a TKI (imatinib or nilotinib) improves upon the quality of the molecular remission seen with TKI alone, as measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) for the Bcr-Abl transcript.
Measured: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2010
- Study completionDec 2015
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 University of Michigan Rogel 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale L. Bixby, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573378
- Sponsor's protocol ID
- UMCC 2006.128
- Other IDs
- HUM9600
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2007
- Last updated
- 25 Jan 2023
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Imatinib or Nilotinib Together With Pegylated Interferon-α2b in Chronic-Phase Chronic Myeloid Leukemia: A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations
- ClinicalTrials.gov ID
- NCT00573378
- Acronym / sponsor ID
- UMCC 2006.128
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- CML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, [IFN]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN-a2b | Experimental | Drug: PEG-IFN-a2b |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have a diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase by having met all of the following criteria at the time of their initial diagnosis:
- Cytogenetic confirmation of Philadelphia chromosome or variants of the t(9;22) translocations. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
- Peripheral blood or bone marrow blast count < 10%.
- Peripheral blood basophil count < 20%.
- Platelet count ≥ 100,000 x 109/L.
Key exclusion criteria (10 listed)
- Patients who have had prior progression of their CML to accelerated phase or blast crisis.
- Patients who have previously undergone hematopoietic stem cell transplantation.
- Patients who have previously been treated with interferon-α.
- Patients with an absolute neutrophil count (ANC) < 1500/mm3 and/or a platelet count < 100,000/mm3.
- Patients with serum bilirubin, SGOT[AST], SGPT[ALT], or serum creatinine > 1.5 x the upper limit of normal (ULN).
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-IFN-a2bAlso: Pegintron®Patients will receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week. Patients and/or caregivers identified by the patient will be taught how to perform subcutaneous injections of the PEG-IFN-α2b by trained nurses in the chemotherapy infusion center at the University of Michigan Comprehensive Cancer Center. Those patients who do not feel comfortable receiving the injections outside of the cancer center, or are deemed unreliable in administering injections per the training nurse, will return to the cancer center infusion room on a weekly basis to receive subsequent injections. | Drug | PEG-IFN-a2b |
Primary outcome
Relapse-free Survival (RFS) Rate 1 Year After Discontinuation of the TKI and IFN
Time frame: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, [IFN]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
1 secondary outcome
Quantitative Reverse Transcriptase-polymerase Chain Reaction (qRT-PCR) for the Bcr-Abl Transcript.
Time frame: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dale L. Bixby, M.D. principal investigator
University of Michigan
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-IFN-a2b in people with Chronic Myeloid Leukemia, run by University of Michigan Rogel 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 19 inclusion and 10 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 25 Jan 2023. 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 25 Jan 2023). 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?
Relapse-free Survival (RFS) Rate 1 Year After Discontinuation of the TKI and IFN (time frame: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)). 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 25 Jan 2023.