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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)

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



- 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.


- 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

- 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


- 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



- 18 to 64

Performance status

- Zubrod 0-3

Life expectancy

- Not specified


- Not specified


- No chronic liver disease

- Hepatitis panel, including hepatitis B and C, negative

- History of hepatitis A with positive antibody allowed


- Creatinine ≤ 1.5 times upper limit of normal OR

- Creatinine clearance > 60 mL/min


- 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


- 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


Biologic therapy

- Not specified


- No prior remission induction chemotherapy for ALL

- Prior hydroxyurea to control WBC count allowed

Endocrine therapy

- Not specified


- Not specified


- Not specified


- No other prior treatment for ALL

Type of Study:


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:


Principal Investigator

Jerry Radich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




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



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Kansas City Kansas City, Missouri  64131
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Montana Cancer Consortium Billings, Montana  59101
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Wesley Medical Center Wichita, Kansas  67214
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Rocky Mountain Oncology Casper, Wyoming  82609
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
McLeod Regional Medical Center Florence, South Carolina  29501
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Independence Regional Health Center Independence, Missouri  64050
Parvin Radiation Oncology Kansas City, Missouri  64116
AnMed Cancer Center Anderson, South Carolina  29621
Frontier Cancer Center Great Falls, Montana  59405