Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

PHASE2TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

March 31, 2009

Conditions
Myeloid Leukemia, ChronicMyeloid Leukemia, Chronic, Accelerated-PhaseBlast PhaseMyeloid Leukemia, Chronic, Chronic-Phase
Interventions
DRUG

Homoharringtonine

"Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles.~Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m\^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule."

DRUG

Imatinib Mesylate

Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.

Trial Locations (1)

77030

Univ. of Texas M.D. Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

ChemGenex Pharmaceuticals

INDUSTRY

NCT00114959 - Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML) | Biotech Hunter | Biotech Hunter