Know Cancer

or
forgot password

TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FIRST COMPLETE REMISSION


Phase 2
15 Years
65 Years
Not Enrolling
Both
Leukemia, Neutropenia, Thrombocytopenia

Thank you

Trial Information

TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FIRST COMPLETE REMISSION


OBJECTIVES: I. Evaluate if front line induction therapy with daunorubicin, vincristine,
prednisone, and asparaginase is sufficiently effective to warrant a phase III trial in
patients with acute lymphocytic leukemia (ALL). II. Assess the toxicity of this regimen in
this patient population. III. Assess disease free and overall survival and toxicity
associated with allogeneic bone marrow transplantation for ALL patients in first remission
following induction and consolidation therapy. IV. Assess disease free and overall survival
and toxicity associated with sequential regimens of mercaptopurine, methotrexate and
vincristine, doxorubicin, dexamethasone, and cyclophosphamide, thioguanine, and cytarabine
in ALL patients in first remission who are ineligible for allogeneic bone marrow
transplantation. V. Evaluate the prognostic significance of cell surface immunophenotype,
Philadelphia chromosome, and polymerase chain reaction detected BCR/abl fusion in this
patient population.

OUTLINE: Patients are stratified according to age (15 to 29 vs 30 to 49 vs 50 to 65),
performance status (0-1 vs 2-3), participating center, and candidate for allogeneic bone
marrow transplantation (yes vs no). Patients receive induction chemotherapy consisting of
daunorubicin IV on days 1-3, vincristine IV on days 1, 8, 15, and 22, oral prednisone on
days 1-28, and asparaginase IV or intramuscularly (IM) on days 15-24. Patients with
persistent leukemia on day 21, receive additional induction therapy consisting of
daunorubicin IV on days 22 and 23, vincristine IV on days 29 and 36, and oral prednisone
continuing to day 42. Patients with CNS leukemia receive additional therapy beginning on day
1 of induction chemotherapy consisting of methotrexate intrathecally (IT) or
intraventricularly twice weekly until blasts are absent in spinal fluid. Patients receive
oral leucovorin calcium every 6 hours for a total of 4 doses following each IT dose in the
absence of blood count recovery. Following absence of spinal fluid blasts, patients receive
methotrexate IT or intraventricularly weekly for 4 weeks then monthly for 1 year. Patients
also receive cranial radiotherapy during consolidation therapy 5 days a week for 2.5 weeks.
Patients with A1 bone marrow receive consolidation therapy following completion of induction
therapy and blood count recovery. Patients receive consolidation therapy consisting of
cyclophosphamide IV on days 1, 15, and 29, cytarabine IV on days 2-5, 9-12, 16-19, and
23-26, oral mercaptopurine on days 1-28, and methotrexate IT on days 2, 9, 16, and 23.
Following completion of consolidation therapy, patients eligible for allogeneic bone marrow
transplantation receive total body radiotherapy 3 times a day on days -7, -6, -5, and twice
on day -4, and eptoposide IV over 4 hours on day -3. Patients undergo allogeneic bone marrow
transplantation on day 0. Following completion of consolidation therapy, patients ineligible
for allogeneic bone marrow transplantation receive maintenance therapy consisting of oral
mercaptopurine on days 1-63, and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, and
57. Patients receive subsequent courses of maintenance therapy when blood counts recover.
Patients receive a second course of maintenance therapy consisting of vincristine IV on days
1, 8, 15, and 22, doxorubicin IV on days 1, 8, 15, and 22, and oral dexamethasone on days
1-28. Patients receive a third course consisting of cyclophosphamide IV on day 1, oral
thioguanine on days 1-14, and cytarabine IV on days 3-6 and 10-13. Patients receive a fourth
course consisting of oral mercaptopurine and oral methotrexate daily for 2 years. Patients
are followed monthly for 6 months and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia FAB class
L1-L2 Mixed immunophenotypic markers with no cytochemical myeloid markers allowed No
non-Hodgkin's lymphoma No chronic myelogenous leukemia in blast crisis Concurrent
registration on the cytogenetics protocol SWOG-9007 required

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: SWOG 0-3 Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 2 times normal (unless elevation due to
leukemia) AST no greater than 3 times normal (unless elevation due to leukemia) No chronic
liver disease Renal: Creatinine no greater than 2 times normal Cardiovascular: Left
ventricular ejection fraction at least 50% by MUGA or echocardiogram No symptomatic
congestive heart failure No symptomatic coronary artery disease No cardiomyopathy No
uncontrolled arrhythmia Other: Not pregnant or nursing Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: No prior remission induction chemotherapy for acute lymphocytic
leukemia

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response

Safety Issue:

No

Principal Investigator

Stephen J. Forman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064250

NCT ID:

NCT00002665

Start Date:

July 1995

Completion Date:

December 2003

Related Keywords:

  • Leukemia
  • Neutropenia
  • Thrombocytopenia
  • untreated adult acute lymphoblastic leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • neutropenia
  • thrombocytopenia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neutropenia
  • Thrombocytopenia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
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
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
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
Swedish Cancer InstituteSeattle, Washington  98104
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
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 - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
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
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Louisiana State University Hospital - ShreveportShreveport, Louisiana  71130-3932