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A PHASE II STUDY OF G3139 (GENASENSE™, NSC # 683428 IND # 58842) + IMATINIB MESYLATE (GLEEVEC®, STI571) IN PATIENTS WITH IMATINIB-RESISTANT CHRONIC MYELOID LEUKEMIA


Phase 2
15 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, Relapsing Chronic Myelogenous Leukemia

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Trial Information

A PHASE II STUDY OF G3139 (GENASENSE™, NSC # 683428 IND # 58842) + IMATINIB MESYLATE (GLEEVEC®, STI571) IN PATIENTS WITH IMATINIB-RESISTANT CHRONIC MYELOID LEUKEMIA


PRIMARY OBJECTIVES:

I. To estimate the cytogenetic response rate of patients with CML who have had less than a
complete hematologic response or less than major cytogenetic response to imatinib mesylate
and who have been treated after two cycles of imatinib mesylate + G3139.

SECONDARY OBJECTIVES:

I. To estimate the hematologic, cytogenetic and molecular response rate and duration in
patients diagnosed with CML who have been treated after two and four cycles of imatinib
mesylate + G3139.

II. To estimate the toxicity of these two drugs given in combination in a cooperative group
setting.

OUTLINE:

Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or
twice daily. Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Patients without a hematologic response after 2
courses go off study. Patients with complete or partial response after 4 courses may
continue to receive oral imatinib mesylate daily.

Patients in cohort 2 receive an escalated dose of oblimersen; if well tolerated, subsequent
cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate.
If oblimersen is not well tolerated in cohort 2, subsequent cohorts receive the original
dose of oblimersen with an escalated dose of imatinib mesylate. The first 6 patients accrued
continue to receive the original dose (dose taken prior to study) of imatinib mesylate
throughout the study.

Patients are followed monthly for 3 months and then every 3 months for 5 years.


Inclusion Criteria:



- Diagnosis of chronic myeloid leukemia (CML) in chronic phase; clonal cytogenetic
evolution alone does not exclude patients

- Patients in whom a Philadelphia chromosome [t(9;22)] or a variant translocation is
not detectable by cytogenetic studies are eligible if they meet one of the following
criteria:

- Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL;

- BCR/ABL translocation present by fluorescence in situ hybridization (FISH)

- Patients must have received prior therapy with imatinib mesylate (>= 400 mg/day for >
8 weeks without a complete hematologic response or >= 400 mg/day for > 6 months
without a major cytogenetic response) and must not have evidence of progressive
disease (accelerated or blast phases)

- Patients must have received a stable dose of imatinib mesylate >= 600 mg/day for at
least 4 weeks without > grade 1 toxicities; the first six patients enrolled will be
restricted to receiving an imatinib mesylate dose of 600 mg/day while on study

- No prior therapy with hydroxyurea, cytarabine, interferon, anagrelide,
homoharringtonine, or any other investigational agent within 4 weeks of study
enrollment

- Patients may not have received other antineoplastic medications (e.g., busulfan)

- No prior stem cell transplantation

- Patients must not require oral anticoagulant therapy

- Non-pregnant and non-nursing; treatment under this protocol would expose an unborn
child to significant risks. Women and men of reproductive potential should agree to
use an effective means of birth control throughout the duration of protocol treatment
and for at least three months after the last dose of imatinib mesylate

- No other serious illnesses which would limit survival to < 2 years, or a psychiatric
condition which would prevent compliance with treatment or informed consent

- No uncontrolled cardiovascular disease, diabetes, pulmonary disease, or infection,
which in the opinion of the treating physician, would make this protocol treatment
unreasonably hazardous for the patient

- Patients with a "currently active" second malignancy other than non-melanoma skin
cancers are not eligible; patients are not considered to have a "currently active"
malignancy if they have completed therapy and are considered by their physician to be
at less than 30% risk of relapse within one year

- Bilirubin =< 2 mg/dL

- Creatinine =< 2 mg/dL

- AST =< 1.5 x Upper Limit of Normal

- PTT =< 1.5 x Upper limit of Normal

- BHCG Negative (if patient of childbearing potential)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cytogenetic response rate in bone marrow

Outcome Time Frame:

42 days

Safety Issue:

No

Principal Investigator

Meir Wetzler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02790

NCT ID:

NCT00049192

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Phase Chronic Myelogenous Leukemia
  • Relapsing Chronic Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606