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SWOG S0325 - "A Phase IIB Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase"
Treatment Plan (Supplied Drug: Dasatinib)
All Tx Arms - Continue x 12 mos or until other protocol criterion met. Arms 1 & 3 may continue protocol therapy past 12 mos at investigator's discretion, until 5 yrs from initial regist.
Arm 1
Imatinib: 400mg, PO, QD w/food (x 12 mos or other protocol criterion met)
Arm 2 (Closed effective 1/10/07)
Imatinib: 400mg, PO, BID w/food
Arm 3
Dasatinib: 100mg, PO, QD
Eligibility
Must have CML in chronic phase based on BM aspir & bx and perip blood counts w/i 28 days pre-regist.
Must be registered w/i 180 days after date of first being diagnosed w/CML, based on cytogenetic or molecular analysis demonstrating presence of Philadelphia chromosome or variants of the (9;22) translocation or testing positive for BCR-ABL by RT-PCR. May have secondary chromosomal abnormalities in addition to Philadelphia chromosome.
Age >18.
Zubrod 0-2.
No prior tx for CML w/exception of hydroxyurea &/or anagrelide.
No prior chemo regimen for perip blood stem cell mobilization. Prior collection of unmobilized perip blood stem cells is permitted.
Serum bili and SGOT or SGPT all <2.0x IULN w/i 14 days pre-regist.
Must be registered to SWOG 9007, "Cytogenetic Studies in Leukemia Pts". Collect pre-tx BM specimen w/i 28 days pre-regist and submit to an approved SWOG Cytogenetics Lab (Children's Mercy Hospital is approved). An aliquot of BM (or perip blood if marrow aspir is a dry tap) must be submitted for FISH analysis. SWOG 9007 also requires submission of BM at time of progression to accelerated or blastic phase of CML or loss of complete hematologic response and q 6 mos while pt is on this study.
Must be registered to SWOG S9910, "Leukemia Centralized Reference Labs & Tissue Repositories". Collect pre-tx perip blood and BM w/i 28 days pre-regist and submit to Lab #93 (SWOG ALL/CLL/CML Repository - Fred Hutchinson Cancer Research Center). SWOG S9910 also requires submission of perip blood and BM at various times after study entry.
No major surgery w/i 28 days after regist. Fully recovered from any other prior major surgery.
No pregnant or nursing women. Women/Men of reproductive potential must use effective contraception.
No other prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, adequately treated Stg I or II cancer currently in complete remission, or other cancer disease-free > 5 yrs.
ECG w/i 42 days pre-regist & none of following pre-study entry: uncontrolled angina, CHF, or MI w/i 6 mos of study entry; diagnosed or suspected congenital long QT syndrome; hx of clinically significant ventricular arrhythmias; prolonged QTc interval on pre-entry EKG (>450 msec); uncontrolled HTN.
No hx of significant bleeding disorder unrelated to cancer, including congenital bleeding disorders and acquired bleeding disorders w/i 1 yr.
PRESTUDY REQUIREMENTS:
H&P, wt, perf status
CBC/diff/platelets
Bili, SGPT, SGOT
Serum creat (for good medical practice; results do not determine eligibility)
Mg (Dasatinib arm - for good medical practice; results do not determine eligibility)
INR, PTT (for good medical practice; results do not determine eligibility)
PBL specimen for PCR*
BM aspir/bx
BM (or PBL) specimen for FISH**
BM specimen for cytogenetics (see SWOG 9007)
PBL or BM specimen for GEP*
ECG (w/i 42 days pre-regist)
* 20ml perip blood and 5ml BM. Collect in heparinized tubes and ship at room temp by overnight mail to: Lab #93 (SWOG ALL/CLL/CML Repository - FHCRC).
** 2ml aliquot of BM (or perip blood only if aspir is a dry tap). Collect in sodium heparin and send by overnight mail w/i 1-5 hrs of drawing to: Lab #31 (Cytogenetics Lab - City of Hope). Include ice pack, but isolate specimen from ice pack.
Signed informed consent.