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A Phase III Study of Interferon-Refractory Patients With BCR/ABL(+) Chronic Myelogenous Leukemia (CML) Treated With Homoharringtonine (NSC #141633) vs. Hydroxyurea


Phase 3
16 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase III Study of Interferon-Refractory Patients With BCR/ABL(+) Chronic Myelogenous Leukemia (CML) Treated With Homoharringtonine (NSC #141633) vs. Hydroxyurea


OBJECTIVES: I. Compare the overall survival of interferon alfa refractory chronic
myelogenous leukemia patients treated with homoharringtonine to those treated with
hydroxyurea. II. Compare the time to progression of these patients treated with these two
drugs. III. Estimate the complete and major cytogenetic response and describe the serial
cytogenetics of these patients treated with these two drugs.

OUTLINE: This is a randomized study. Patients are randomized to receive one of two
treatments. Arm I: Induction: Patients receive homoharringtonine IV continuously over 24
hours daily for 14 days. Induction continues every 28 days for a maximum of 6 courses or
until hematopoietic recovery. Maintenance: Patients receive homoharringtonine IV
continuously over 24 hours daily for 5 days. Treatment repeats every 28 days. Arm II:
Induction: Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts
are achieved. Maintenance: Patients receive oral hydroxyurea daily every 28 days to maintain
acceptable blood counts. Treatment in both arms continues for a minimum of 6 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 6
months for a maximum of 10 years.

PROJECTED ACCRUAL: A total of 480 patients (240 per arm) will be accrued for this study
within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Cytologically proven chronic phase chronic myelogenous leukemia
Philadelphia chromosome detectable by cytogenetic studies OR 1 of the following: BCR/ABL
protein detectable by immunoblotting BCR/ABL rearrangement detectable by Southern blot
analysis Polymerase chain reaction positive fusion transcripts for BCR/ABL BCR/ABL
translocation present by fluorescence in situ hybridization No prior intolerance or
failure to respond to hydroxyurea Must have failed adequate trial (5M units/m2/day) of
interferon alfa (IFN) or the combination of IFN and cytarabine as defined by 1 of the
following: Failure to achieve complete hematologic response after 6 months of IFN Failure
to achieve any cytogenetic response (i.e., still 100% Philadelphia chromosome positive)
after 12 months of IFN Intolerable adverse effects of IFN after at least 1 month of IFN
Significant documented toxicity of grade 3 or greater due to IFN required Loss of a prior
hematologic remission or cytogenetic response to IFN Two-fold increase in WBC count
compared to WBC count when IFN initiated

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not
specified Renal: Not specified Cardiovascular: No uncontrolled tachyarrhythmias (e.g.,
atrial fibrillation, paroxysmal superventricular tachycardia, or ventricular tachycardias
not adequately controlled) Other: Not pregnant or nursing Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior interferon alfa
Chemotherapy: See Disease Characteristics No prior homoharringtonine Less than 180 days
cumulative prior hydroxyurea No more than 60 days hydroxyurea after failing interferon
Endocrine therapy: No concurrent hormones except for nondisease related conditions (e.g.,
insulin for diabetes, estrogen for osteopenia) Concurrent steroids for adrenal failure
allowed Radiotherapy: No concurrent palliative radiotherapy Surgery: No concurrent
splenectomy except for emergency management

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Meir Wetzler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067617

NCT ID:

NCT00004933

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Rhode Island HospitalProvidence, Rhode Island  02903
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Loyola University Medical CenterMaywood, Illinois  60153
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705