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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Medical Research Council |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002514 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Biological: sargramostim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission |
| Estimated Enrollment: | 590 |
| Study Start Date: | April 1993 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute lymphoblastic leukemia (ALL)
More than 25% lymphoblasts in bone marrow
Philadelphia (Ph) chromosome status determined by cytogenetics, fluorescence in situ hybridization (FISH), and/or RNA analysis
Patients age 50 and under must be HLA typed during induction therapy of study treatment OR provide a written explanation for not undergoing HLA typing
Allogeneic stem cell transplantation patients must meet the following criteria:
Appropriate HLA histocompatible donor available
Postinduction therapy:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Induction therapy:
Postinduction therapy:
Life expectancy:
Hematopoietic:
Hepatic:
Induction therapy:
Postinduction therapy:
Renal:
Induction therapy:
Postinduction therapy:
Cardiovascular:
Induction and postinduction therapy:
Postinduction therapy:
Pulmonary:
Induction therapy:
Postinduction therapy:
Other:
Induction and postinduction therapy:
Postinduction therapy:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Induction and postinduction therapy:
Postinduction therapy:
Contacts and Locations
Hide Study Locations| United States, Colorado | |
| Aurora Presbyterian Hospital | |
| Aurora, Colorado, United States, 80012 | |
| Boulder Community Hospital | |
| Boulder, Colorado, United States, 80301-9019 | |
| CCOP - Colorado Cancer Research Program | |
| Denver, Colorado, United States, 80224-2522 | |
| Hope Cancer Care Center at Longmont United Hospital | |
| Longmont, Colorado, United States, 80502 | |
| North Suburban Medical Center | |
| Thornton, Colorado, United States, 80229 | |
| St. Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| Sky Ridge Medical Center | |
| Lone Tree, Colorado, United States, 80124 | |
| Penrose Cancer Center at Penrose Hospital | |
| Colorado Springs, Colorado, United States, 80933 | |
| St. Mary - Corwin Regional Medical Center | |
| Pueblo, Colorado, United States, 81004 | |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | |
| Grand Junction, Colorado, United States, 81502 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-2875 | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Illinois | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Evanston Northwestern Healthcare - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| United States, Indiana | |
| Methodist Cancer Center at Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Iowa | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01199 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Tufts-NEMC Cancer Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48912-1811 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Duluth Clinic Cancer Center - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| HealthEast Cancer Care at St. Joseph's Hospital | |
| St Paul, Minnesota, United States, 55102 | |
| HealthEast Cancer Care at Woodwinds Health Campus | |
| Woodbury, Minnesota, United States, 55125 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| MeritCare Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Meeker County Memorial Hospital | |
| Lichfield, Minnesota, United States, 55355 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Miller - Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Minnesota Oncology Hematology, PA - Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| Park Nicollet Cancer Center | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| St. Francis Cancer Center at St. Francis Medical Center | |
| Shakopee, Minnesota, United States, 55379 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Aultman Cancer Center at Aultman Hospital | |
| Canton, Ohio, United States, 44710-1799 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Jewish Hospital Cancer Center | |
| Cincinnati, Ohio, United States, 45236 | |
| Mercy Cancer Center at Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| St. Rita's Medical Center | |
| Lima, Ohio, United States, 45801 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Drexel University College of Medicine - Center City Hahnemann Campus | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Wisconsin | |
| Dean Medical Center - Madison | |
| Madison, Wisconsin, United States, 53717 | |
| Froedtert Hospital and Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Marshfield Clinic - Indianhead Center | |
| Rice Lake, Wisconsin, United States, 54868 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Study Chair: | Jacob M. Rowe, MD | Rambam Health Care Campus |
| Investigator: | Mark R. Litzow, MD | Mayo Clinic |
| Study Chair: | Antony H. Goldstone, FRCP | University College London Hospitals |
More Information
| Study ID Numbers: | CDR0000078099, ECOG-2993, MRC-LEUK-UKALL-XII, EST-4491 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002514 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult acute lymphoblastic leukemia in remission |
|
Anti-Inflammatory Agents Dexamethasone Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Protein Kinase Inhibitors Hormones Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Etoposide Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Imatinib Neoplasms Mitoxantrone |