Accelerated Phase Chronic Myelogenous LeukemiaPhase 2NCT00054431
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
A Phase 2 study testing imatinib mesylate, decitabine and laboratory biomarker analysis in people with Accelerated Phase Chronic Myelogenous Leukemia and Blastic Phase Chronic Myelogenous Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase 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?
- Any age
- Conditions the study is for
- Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia
- What is being tested?
- imatinib mesylate, decitabine and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2007
- Phase
- Phase 2
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed chronic myelogenous leukemia
- Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
- Accelerated or non-lymphoid blastic phase
- Performance status - ECOG 0-2
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 2 times ULN
Show all 18Show fewer
- Creatinine less than 2.0 mg/dL
- Normal cardiac function
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior decitabine
- At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
- Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
- Prior imatinib mesylate allowed
- Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
- No concurrent grapefruit or grapefruit juice
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells
Read the detailed description
OBJECTIVES:
- Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.
OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
- Being tested
- imatinib mesylate, decitabine, laboratory biomarker analysis
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Blast Crisis, 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.
imatinib mesylateDrug
Also called CGP 57148, Gleevec, Glivec
Given orally
decitabineDrug
Also called 5-aza-dCyd, 5AZA, DAC
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (imatinib mesylate, decitabine) | Experimental | Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: imatinib mesylate; Drug: decitabine; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and partial response
Measured: 6 months
Hematologic improvement
Measured: Up to 1 year
Duration of response
Measured: Date of documented response until relapse, assessed up to 4 years
Secondary outcomes (1)
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startJan 2003
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Issa, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054431
- Sponsor's protocol ID
- NCI-2012-02516
- Other IDs
- MDA-ID-02205, N01CM62202, CDR0000270678
- Status last verified
- Jan 2013
- First submitted
- 5 Feb 2003
- Last updated
- 23 Jan 2013
- Results posted
- No