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LeukemiaPhase 2NCT00015847

Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

A Phase 2 study testing recombinant interferon alfa and imatinib mesylate in people with Leukemia, run by OHSU Knight Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Leukemia
What is being tested?
recombinant interferon alfa and imatinib mesylate
How many people
25 participants
Where
2 sitesUnited States
Study dates
Apr 2001to May 2011
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Cytogenetically confirmed chronic myelogenous leukemia (CML)
  • Less than 15% blasts in peripheral blood or bone marrow
  • Less than 30% blasts and promyelocytes in peripheral blood or bone marrow
  • Less than 20% basophils in blood or bone marrow
  • Platelet count at least 100,000/mm^3
  • No leukemia beyond bone marrow, blood, liver, or spleen
  • No chloroma
  • Phase I (closed to accrual as of 7/9/03):
  • Philadelphia (Ph) chromosome-positive CML in chronic phase
  • Phase II:
  • Newly diagnosed Ph chromosome-positive CML in chronic phase
  • Initial diagnosis within 6 months of study
  • No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride
  • Phase I (closed to accrual as of 7/9/03) and II:
  • No identified sibling donors where allogeneic stem cell transplantation is elected as first-line therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective barrier contraception during and for at least 3 months after study participation
  • No other serious uncontrolled medical condition
  • No autoimmune disease
  • No prior noncompliance to medical regimens or potential unreliability
  • No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I [closed to accrual as of 7/9/03])

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior bone marrow or peripheral blood stem cell transplantation
  • At least 2 weeks since prior interferon alfa (phase I [closed to accrual as of 7/9/03])

Chemotherapy:

  • See Disease Characteristics
  • At least 6 weeks since prior busulfan (phase I [closed to accrual as of 7/9/03] )
  • At least 2 weeks since prior cytarabine (phase I [closed to accrual as of 7/9/03])
  • No concurrent chemotherapy
  • Concurrent hydroxyurea allowed during the first 3 months of study

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior investigational agents other than imatinib mesylate (phase I [closed to accrual as of 7/9/03])
  • No concurrent grapefruit juice
  • Concurrent anagrelide hydrochloride allowed during the first 3 months of study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase I/II Dose-Finding Study to Determine the Safety, Tolerability, and Anti-Leukemic Effects of STI571 (NSC 716051) in Combination With Interferon-alpha in Patients With Chronic Myelogenous Leukemia in Chronic Phase

RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of interferon alfa administered with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia. (Phase I closed to accrual as of 7/9/03.)
  • Determine the safety and tolerability of this regimen in this patient population.
  • Determine the complete, major, and minor cytogenetic response rates and complete hematologic response rate in patients after 6 and 12 months of treatment with this regimen.
  • Determine the molecular response (reverse transcriptase-polymerase chain reaction for bcr-abl) rate in patients who have a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

  • Phase I (closed to accrual as of 7/9/03): Patients receive oral imatinib mesylate once daily beginning on day 1 and interferon alfa (IFN-A) subcutaneously once daily or 3 times weekly beginning on day 14. Courses repeat every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of 1 year of therapy, patients may receive additional therapy, provided that the patient is benefiting from imatinib mesylate. IFN-A is discontinued in patients who achieve a molecular remission that is confirmed on 2 successive bone marrow samples. Imatinib mesylate is discontinued in patients who achieve and maintain a molecular remission for 2 years.

Sequential dose escalation of IFN-A is followed by sequential dose escalation of imatinib mesylate. Cohorts of 3-6 patients receive escalating doses of IFN-A and then imatinib mesylate until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive imatinib mesylate and IFN-A as in phase I at the established MTD.

Patients are followed for 30 days.

PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for the phase I portion of this study. (Phase I closed to accrual as of 7/9/03.) A total of 40 patients will be accrued for the phase II portion of the study within 3-4 months.

Conditions
Leukemia
Being tested
recombinant interferon alfa, imatinib mesylate
Keywords
relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myeloid, Chronic-Phase, 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.

  • recombinant interferon alfaBiological

    IFN-α will be given at a dose ranging up to 5 MIU daily via subcutaneous injection.

  • imatinib mesylateDrug

    Also called STI571

    Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Cytogenetic Response at 6 and 12 Months (Phase II)

    Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:

    Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%).

    Measured: At 6 and 12 months during phase II

  2. Minor Cytogenetic Response at 6 and 12 Months (Phase II)

    Measured: At 6 and 12 months during phase II

  3. Complete Hematologic Response at 6 and 12 Months (Phase II)

    Measured: At 6 and 12 months during phase II

  4. Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)

    Measured: At 6 and 12 months during phase II

  5. Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)

    1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death

    Measured: 12 Months

  6. Major Cytogenetic Response After 6 and 12 Months of Treatment.

    Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:

    Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%).

    *Major cytogenetic response includes complete and partial cytogenetic response.

    Measured: 6 and 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

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
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015847
Sponsor's protocol ID
CDR0000068443
Other IDs
OHSU-6263, OHSU-409, NCI-2794, OHSU-HEM-00072-LX
Status last verified
Aug 2025
First submitted
6 May 2001
Last updated
22 Aug 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant interferon alfa and imatinib mesylate in people with Leukemia, run by OHSU Knight Cancer Institute at 2 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?

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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 20 Aug 2012). 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?

Complete Cytogenetic Response at 6 and 12 Months (Phase II) (time frame: At 6 and 12 months during phase II). The study lists 6 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 NCT00015847.

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 22 Aug 2025.

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