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Childhood Chronic Myelogenous LeukemiaPhase 2NCT00030394

Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

A Phase 2 study testing imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Childhood Chronic Myelogenous Leukemia and Chronic Myelogenous Leukemia, BCR-ABL1 Positive, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
imatinib mesylate, laboratory biomarker analysis and pharmacological study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
Sep 2002to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of Philadelphia chromosome positive (Ph+) chronic phase chronic myelogenous leukemia (CML)
  • Stratum I (closed to accrual as of 12/05/03):
  • CML in first chronic phase with resistance to interferon alfa (IFN-A) therapy defined as one of the following:
  • WBC count at least 20,000/mm^3 after at least 3 months of treatment with an IFN-A-containing regimen
  • Rising WBC count (at least 100% increase to a level of at least 20,000/mm^3) by two samples at least two weeks apart while receiving treatment with an IFN-A-containing regimen
  • At least 66% Ph+ cells in bone marrow after 1 year of IFN-A therapy
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  • At least 30% increase in Ph+ cells in bone marrow after IFN-A-induced cytogenetic response while continuing to receive IFN-A therapy
  • Intolerance to interferon therapy defined as more than two grade 2 toxic effects or any grade 3 toxic effect related to interferon therapy, except grade 3 fever, that is persistent beyond the first 28-day course of therapy and unresponsive to standard supportive care interventions
  • Stratum II (closed to accrual as of 7/29/05): CML recurring after stem cell transplantation or in second or subsequent chronic phase
  • No molecular relapse (only evidence is detection of bcr-abl rearrangement with normal bone marrow and blood morphology and normal standard cytogenetic analysis)
  • Stratum III (closed to accrual as of 7/29/05): Newly diagnosed CML in first chronic phase with no prior treatment except hydroxyurea
  • Stratum IV: Newly diagnosed CML in first chronic phase with no prior treatment except hydroxyurea
  • No accelerated or blast phase defined as one or more of the following:
  • WBC doubling time less than 5 days
  • Chloroma
  • Medullary fibrosis
  • More than 10% blasts in peripheral blood or bone marrow
  • More than 20% promyelocytes in peripheral blood or bone marrow
  • More than 20% basophils and eosinophils in peripheral blood
  • Performance status - ECOG 0-2
  • At least 8 weeks
  • See Disease Characteristics
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
  • Bilirubin no greater than 1.5 times normal
  • ALT less than 3.0 times normal
  • Albumin greater than 2 g/dL
  • Creatinine no greater than 1.5 times normal
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No CNS toxicity greater than grade 2
  • See Disease Characteristics
  • No prior immunotherapy (for patients in stratum III [closed to accrual as of 7/29/05] and stratum IV only)
  • At least 3 months since prior stem cell transplantation (SCT) (patients with allogeneic SCT must have no active graft-versus-host disease [GVHD] and have stable use of steroids) (for patients in stratum II only )
  • At least 1 week since prior growth factors
  • At least 1 week since prior biologic therapy, including interferon alfa (for patients in stratum I [closed to accrual as of 12/05/03] and stratum II only)
  • Recovered from prior immunotherapy
  • No concurrent immunomodulating agents
  • See Disease Characteristics
  • No prior chemotherapy (for patients in stratum III [closed to accrual as of 7/29/05] and stratum IV only)
  • At least 6 weeks since prior busulfan or nitrosoureas
  • At least 7 days since prior hydroxyurea
  • At least 7 days since prior low-dose cytarabine (less than 30 mg/m^2 every 12 to 24 hours)
  • At least 14 days since prior moderate-dose cytarabine (100-200 mg/m^2 for 5 to 7 days)
  • At least 28 days since prior high-dose cytarabine (1-3 g/m^2 every 12 to 24 hours for 6 to 12 doses)
  • At least 21 days since all other cytotoxic chemotherapy
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy
  • No concurrent steroids other than for controlled GVHD in patients with prior allogeneic SCT
  • No prior radiotherapy (for patients in stratum III [closed to accrual as of 7/29/05] and stratum IV only)
  • At least 2 weeks since prior local palliative (small port) radiotherapy*
  • At least 3 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of pelvis*
  • At least 6 weeks since prior substantial bone marrow radiotherapy*
  • Recovered from prior radiotherapy
  • No prior imatinib mesylate
  • No concurrent enzyme-activating anticonvulsants
  • No concurrent warfarin
  • No concurrent naturopathic agents or herbal medicines
  • No other concurrent investigational agents
  • Concurrent low-molecular weight heparin allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Oncology Group

    Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase II Study of Gleevec in Ph+ Chronic Phase Chronic Myelogenous Leukemia

This phase II trial is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth

Read the detailed description

OBJECTIVES:

  1. Determine the response rate in patients with Philadelphia chromosome positive chronic phase chronic myelogenous leukemia treated with imatinib mesylate.

II. Determine the disease-free survival of patients treated with this drug. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the toxic effects of this drug in these patients. V. Determine the rates of hematological, cytogenetic, and molecular response and time to response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia [CML] in first chronic phase after failing interferon therapy or demonstrating intolerance to interferon [closed to accrual as of 12/05/03] vs CML relapsing after stem cell transplantation or in second or subsequent chronic phase [closed to accrual as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior treatment [closed to accrual as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior treatment).

Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve a complete hematologic response after 3 courses or a partial or complete cytogenic response after 6 courses are removed from the study.

PROJECTED ACCRUAL: A total of 109 patients (30 for stratum I [closed to accrual as of 12/05/03] and stratum II [closed to accrual as of 7/29/05], 34 for stratum III [closed to accrual as of 7/29/05], and 45 for stratum IV) will be accrued for this study within 2 years.

Being tested
imatinib mesylate, laboratory biomarker analysis, pharmacological study
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called CGP 57148, Gleevec, Glivec

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00030394
Study groupRoleWhat they receive
Treatment (imatinib mesylate)ExperimentalPatients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve a complete hematologic response after 3 courses or a partial or complete cytogenic response after 6 courses are removed from the study.
Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. Response rate

    Measured: Up to 5 years

  2. Disease-free survival

    Measured: Up to 5 years

  3. Toxicities graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Time to achieve hematological cytogenetic and molecular response

    Studied in a multivariate model using a Cox proportional hazards regression model.

    Measured: Up to 12 months

  2. Event free survival

    Measured: Up to 5 years

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 startSep 2002
  3. Primary completionOct 2007

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030394
Sponsor's protocol ID
NCI-2012-01867
Other IDs
AAML0123, U10CA098543, CDR0000069161
Status last verified
Jan 2013
First submitted
14 Feb 2002
Last updated
17 Jan 2013
Results posted
No

Publications

  • Champagne MA, Fu CH, Chang M, Chen H, Gerbing RB, Alonzo TA, Cooley LD, Heerema NA, Oehler V, Wood C, French ME, Arceci RJ, Smith FO, Bernstein ML. Higher dose imatinib for children with de novo chronic phase chronic myelogenous leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 15;57(1):56-62. doi: 10.1002/pbc.23031. Epub 2011 Apr 4.

    PubMed 21465636

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Childhood Chronic Myelogenous Leukemia and Chronic Myelogenous Leukemia, BCR-ABL1 Positive, run by National Cancer Institute (NCI) 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 62 inclusion and 0 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: finished, as of the sponsor's last update on 17 Jan 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate (time frame: Up to 5 years). The study lists 3 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 NCT00030394, 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 17 Jan 2013.

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