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A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy


Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy


OBJECTIVES:

Primary

- Determine the probability of 1-year continuous complete remission in patients with
newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy
comprising daunorubicin, vincristine, prednisone, and pegaspargase; and second
induction chemotherapy comprising high-dose cytarabine and mitoxantrone.

Secondary

- Determine the frequency and severity of toxic effects of these induction regimens
followed by consolidation therapy comprising cyclophosphamide, cytarabine,
mercaptopurine, and methotrexate and maintenance chemotherapy comprising
mercaptopurine, methotrexate, vincristine, doxorubicin, dexamethasone,
cyclophosphamide, thioguanine, and cytarabine in these patients.

Other objectives (if funding allows):

- To evaluate in a preliminary manner the significance of detecting minimal residual
disease as a prognostic factor for survival and relapse-free survival of patients
receiving chemotherapy

- To evaluate in a preliminary manner the pattern of gene expression of patients entered
onto the trial and its relationship to cytogenetics/FISH risk classification, overall
survival, and relapse-free survival

OUTLINE: This is a multicenter study.

- First induction chemotherapy: Patients receive daunorubicin IV on days 1-3; vincristine
IV on days 1, 8, 15, and 22; prednisone IV or orally on days 1-28, followed by a taper
to day 35; and pegaspargase IV or subcutaneously (SC) on day 15. Patients with CNS
leukemia also receive methotrexate intrathecally (IT) or intraventricularly twice
weekly and oral leucovorin calcium four times daily for 4 doses after each
administration of methotrexate. When blasts are no longer present in the spinal fluid,
patients receive methotrexate IT or intraventricularly once weekly for 4 weeks and then
once monthly for 1 year.

Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1
peripheral blood status or those with resistant disease proceed to second induction therapy.

- Second induction chemotherapy: Patients receive high-dose cytarabine IV on days 1-5;
mitoxantrone IV on day 3; and filgrastim (G-CSF) SC or IV beginning on day 7 and
continuing until blood counts recover. Patients with CNS leukemia also receive
methotrexate and leucovorin calcium as in first induction chemotherapy.

Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1
peripheral blood status with no extramedullary disease (other than CNS involvement) proceed
to consolidation chemotherapy. Patients with resistant disease OR Philadelphia chromosome-
or BCR/ABL-positive disease are removed from the study after receiving double induction
chemotherapy.

- Consolidation chemotherapy: Patients receive cyclophosphamide IV on days 1, 15, and 29;
cytarabine IV on days 2-5 and 16-19; oral mercaptopurine on days 1-28; and methotrexate
IT or intraventricularly on days 2, 9, 16, and 23. Patients with CNS leukemia also
undergo cranial radiotherapy once daily, 5 days a week, for 2 weeks.

Patients in complete remission proceed to maintenance chemotherapy.

- Maintenance chemotherapy:

- Course 1: Patients receive oral mercaptopurine on days 1-63 and oral methotrexate
on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients proceed to course 2 after
blood counts recover.

- Course 2: Patients receive vincristine IV and doxorubicin IV on days 1, 8, 15, and
22 and oral dexamethasone on days 1-28. Patients proceed to course 3 after blood
counts recover.

- Course 3: Patients receive cyclophosphamide IV on day 1; oral thioguanine on days
1-14; and cytarabine IV on days 3-6 and 10-13. Patients proceed to course 4 after
blood counts recover.

- Course 4: Patients receive oral mercaptopurine once daily for 2 years and oral
methotrexate once weekly for 2 years.

Treatment continues in the absence of disease relapse or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, every 6
months for 1 year, and then annually for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Morphologically confirmed acute lymphoblastic leukemia (ALL), meeting any of the
following criteria:

- FAB class L1 or L2 disease

- Mixed lineage ALL

- Ph-negative/BCR/ABL-negative

- Newly diagnosed disease

- Patients with the following diagnoses are not eligible:

- FAB class L3 ALL

- Non-Hodgkin's lymphoma

- Chronic myelogenous leukemia in lymphoid blast crisis

- Mixed lineage acute myeloid leukemia

- Acute minimally differentiated myeloid leukemia (M0)

- Must be registered on protocols SWOG-9007 AND SWOG-S9910

PATIENT CHARACTERISTICS:

Age

- 18 to 64

Performance status

- Zubrod 0-3

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No chronic liver disease

- Hepatitis panel, including hepatitis B and C, negative

- History of hepatitis A with positive antibody allowed

Renal

- Creatinine ≤ 1.5 times upper limit of normal OR

- Creatinine clearance > 60 mL/min

Cardiovascular

- Left ventricular function normal

- Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram

- No symptomatic congestive heart failure

- No coronary artery disease

- No cardiomyopathy

- No uncontrolled arrhythmia

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior remission induction chemotherapy for ALL

- Prior hydroxyurea to control WBC count allowed

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No other prior treatment for ALL

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Continuous Complete Remission at 1 Year

Outcome Description:

A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.

Outcome Time Frame:

After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year

Safety Issue:

No

Principal Investigator

Jerry Radich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000426447

NCT ID:

NCT00109837

Start Date:

April 2005

Completion Date:

November 2014

Related Keywords:

  • Leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • untreated adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neoplasm, Residual

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Wesley Medical CenterWichita, Kansas  67214
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Menorah Medical CenterOverland Park, Kansas  66209
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Rocky Mountain OncologyCasper, Wyoming  82609
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
McLeod Regional Medical CenterFlorence, South Carolina  29501
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Independence Regional Health CenterIndependence, Missouri  64050
Parvin Radiation OncologyKansas City, Missouri  64116
AnMed Cancer CenterAnderson, South Carolina  29621
Frontier Cancer CenterGreat Falls, Montana  59405