Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 11/4/2018 |
| Start Date: | October 2016 |
| End Date: | July 2018 |
First-Line Dasatinib or Nilotinib Followed by Response Guided Switch to Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in
treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in
which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature
blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth
of cancer cells by blocking some of the enzymes needed for cell growth.
treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in
which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature
blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth
of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE:
I. To assess incidence of major molecular response (MMR) at 12 months.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 12 and 24 months.
II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12
and 24 months.
III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.
IV. To assess safety.
V. To assess patient reported outcomes (PRO).
TERTIARY OBJECTIVES:
I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on
diagnostic bone marrow.
II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine
kinase inhibitors (TKIs) discontinuation trials.
OUTLINE:
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at
the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3
months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine
leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib
mesylate PO QD.
After completion of study treatment, patients are followed up at 2 weeks and then up to 60
months.
I. To assess incidence of major molecular response (MMR) at 12 months.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 12 and 24 months.
II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12
and 24 months.
III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.
IV. To assess safety.
V. To assess patient reported outcomes (PRO).
TERTIARY OBJECTIVES:
I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on
diagnostic bone marrow.
II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine
kinase inhibitors (TKIs) discontinuation trials.
OUTLINE:
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at
the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3
months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine
leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib
mesylate PO QD.
After completion of study treatment, patients are followed up at 2 weeks and then up to 60
months.
Inclusion Criteria:
- Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML)
(by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days
prior to enrollment)
- Clinically significant gastrointestinal disease, digestive dysfunction, or surgery
that would compromise absorption of oral administration of medications
- Able to give written informed consent and comply with all study visits and procedures
Exclusion Criteria:
- Chronic myeloid leukemia (CML) in AP or BP
- Unable to receive TKI for insurance reasons (uninsurable)
- Refuse or unable to perform telephone or video conferences with research coordinator
- Subjects who are pregnant, breast feeding or sexually active and unwilling to use
effective birth control while on treatment with TKI
- Any medical or psychological condition that, in the opinion of the investigator, might
interfere with the subject's participation in the trial, poses any additional risk for
the subject, or confounds the assessment of the subject
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