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Spots Global Cancer Trial Database for S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Official Title: 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

Study ID: NCT00109837

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), and giving the drugs in different combinations may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Menorah Medical Center, Overland Park, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Wesley Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States

Independence Regional Health Center, Independence, Missouri, United States

Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States

Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri, United States

St. Joseph Medical Center, Kansas City, Missouri, United States

North Kansas City Hospital, Kansas City, Missouri, United States

Parvin Radiation Oncology, Kansas City, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

Research Medical Center, Kansas City, Missouri, United States

Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States

Liberty Hospital, Liberty, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States

Billings Clinic - Downtown, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

St. James Healthcare Cancer Care, Butte, Montana, United States

Big Sky Oncology, Great Falls, Montana, United States

Frontier Cancer Center, Great Falls, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

Northern Montana Hospital, Havre, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Glacier Oncology, PLLC, Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Community Medical Center, Missoula, Montana, United States

Guardian Oncology and Center for Wellness, Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Rutherford Hospital, Rutherfordton, North Carolina, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

AnMed Cancer Center, Anderson, South Carolina, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

McLeod Regional Medical Center, Florence, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States

Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States

St. Joseph Cancer Center, Bellingham, Washington, United States

Olympic Hematology and Oncology, Bremerton, Washington, United States

Columbia Basin Hematology, Kennewick, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Harborview Medical Center, Seattle, Washington, United States

Minor and James Medical, PLLC, Seattle, Washington, United States

Group Health Central Hospital, Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States

Polyclinic First Hill, Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States

Cancer Care Northwest - Spokane South, Spokane, Washington, United States

Rocky Mountain Oncology, Casper, Wyoming, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States

Contact Details

Name: Jerry Radich, MD

Affiliation: Fred Hutchinson Cancer Center

Role: STUDY_CHAIR

Name: Frederick R. Appelbaum, MD

Affiliation: Fred Hutchinson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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