Leukemia Clinical Trial
Official title:
Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission
NCT number | NCT00002514 |
Other study ID # | CDR0000078099 |
Secondary ID | E2993MRC-LEUK-UK |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 7, 1993 |
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1929 |
Est. completion date | |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed acute lymphoblastic leukemia (ALL) - More than 25% lymphoblasts in bone marrow - Patients with myeloid antigen expression AND unequivocal lymphoid immunophenotype are eligible - Philadelphia (Ph) chromosome status determined by cytogenetics, fluorescence in situ hybridization (FISH), and/or RNA analysis - Patients determined to be Ph chromosome negative by cytogenetics, but positive for BCR-ABL by FISH or polymerase chain reaction are considered Ph chromosome positive - Patients with Ph chromosome-positive disease may be up to age 65 - No myelodysplasia or other antecedent hematologic disorder - 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 - A and B typing required - C and DR typing done if feasible - Allogeneic stem cell transplantation patients must meet the following criteria: - Appropriate HLA histocompatible donor available - Ph chromosome-negative patients must have HLA identical sibling - Ph chromosome-positive patients must have HLA identical, HLA-matched unrelated, or haploidentical related donor - Postinduction therapy: - CSF negative for leukemia - No occult or overt leukemic meningitis - Documented complete remission PATIENT CHARACTERISTICS: Age: - 15 to 65 Performance status: - Induction therapy: - Not specified - Postinduction therapy: - 0-1 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Induction therapy: - Direct bilirubin = 2.0 mg/dL - Postinduction therapy: - Direct bilirubin < 2.0 mg/dL - SGPT or SGOT < 3 times normal Renal: - Induction therapy: - Creatinine < 2 mg/dL - Postinduction therapy: - Creatinine = 2 mg/dL - Creatinine clearance = 60 mL/min Cardiovascular: - Induction and postinduction therapy: - No significant cardiac disease requiring digoxin and/or diuretics - No major ventricular dysrhythmia requiring medication - No ischemic heart disease requiring medication - Postinduction therapy: - Cardiac ejection fraction = 50% for patients under consideration for transplantation Pulmonary: - Induction therapy: - Not specified - Postinduction therapy: - FEV_1 = 60% of predicted for patients under consideration for transplantation - DLCO = 50% of predicted for patients under consideration for transplantation Other: - Induction and postinduction therapy: - HIV negative - No concurrent organ damage or other medical problem (e.g., psychiatric disorder or drug abuse) that would preclude study therapy - Not pregnant - Postinduction therapy: - No persistent infection PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent umbilical cord allogeneic transplantation Chemotherapy: - Not specified Endocrine therapy: - Prior corticosteroids for ALL allowed Radiotherapy: - Not specified Surgery: - Not specified Other: - Induction and postinduction therapy: - No other prior therapy for ALL - Postinduction therapy: - No concurrent antibiotics |
Country | Name | City | State |
---|---|---|---|
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Tufts-NEMC Cancer Center | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Aultman Cancer Center at Aultman Hospital | Canton | Ohio |
United States | Mercy Cancer Center at Mercy Medical Center | Canton | Ohio |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Jewish Hospital Cancer Center | Cincinnati | Ohio |
United States | Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | CCOP - Colorado Cancer Research Program | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | St. Joseph Hospital | Denver | Colorado |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Hinsdale Hematology Oncology Associates | Hinsdale | Illinois |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana |
United States | Foote Hospital | Jackson | Michigan |
United States | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Meeker County Memorial Hospital | Litchfield | Minnesota |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado |
United States | Dean Medical Center - Madison | Madison | Wisconsin |
United States | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin |
United States | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota |
United States | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain | Connecticut |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia | Pennsylvania |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Seton Cancer Institute - Saginaw | Saginaw | Michigan |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Park Nicollet Cancer Center | Saint Louis Park | Minnesota |
United States | HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota |
United States | Regions Hospital Cancer Care Center | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Medical X-Ray Center, PC | Sioux Falls | South Dakota |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield | Massachusetts |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota |
United States | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | Medical Research Council, National Cancer Institute (NCI) |
United States,
Ferrando AA, Neuberg D, Dodge RK, et al.: Adult T-cell ALL patients whose lymphoblasts express the HOX11 oncogene have an excellent prognosis when treated with chemotherapy and are not candidates for allogeneic bone marrow transplantaton in first remissio
Ferrando AA, Neuberg D, Dodge RK, et al.: Adult T-cell ALL patients whose lymphoblasts express the HOX11 oncogene have an excellent prognosis when treated with chemotherapy and are not candidates for allogeneic bone marrow transplantaton in first remission. [Abstract] Blood 100 (11 pt 1): A-578, 2002.
Fielding AK, Richards SM, Chopra R, Lazarus HM, Litzow MR, Buck G, Durrant IJ, Luger SM, Marks DI, Franklin IM, McMillan AK, Tallman MS, Rowe JM, Goldstone AH; Medical Research Council of the United Kingdom Adult ALL Working Party; Eastern Cooperative Onc — View Citation
Fielding AK, Richards SM, Lazarus HM, et al.: Does imatinib change the outcome in Philapdelphia chromosome positive acute lymphoblastic leukaemia in adults? Data from the UKALLXII/ECOG2993 study. [Abstract] Blood 110 (11): A-8, 2007.
Fielding AK, Rowe JM, Richards SM, Buck G, Moorman AV, Durrant IJ, Marks DI, McMillan AK, Litzow MR, Lazarus HM, Foroni L, Dewald G, Franklin IM, Luger SM, Paietta E, Wiernik PH, Tallman MS, Goldstone AH. Prospective outcome data on 267 unselected adult p — View Citation
Goldstone AH, Chopra R, Buck G, et al.: The outcome of 267 Philadelphia positive adults in the international UKALL12/ECOG E 2993 study. Final analysis and the role of allogeneic transplant in those under 50 years. [Abstract] Blood 102 (11 Pt 1): A-268, 20
Goldstone AH, Lazarus HJ, Richards SM, et al.: The outcome of 551 1st CR transplants in adult ALL from the UKALL XII/ECOG 2993 study. [Abstract] Blood 104 (11): A-615, 2004.
Goldstone AH, Prentice HG, Durrant J, et al.: Allogeneic transplant (related or unrelated donor) Is the preferred treatment for adult Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL). Results from the international ALL trial (MRC
Goldstone AH, Richards S, Wiernik PH, et al.: Philadelphia chromosome positive patients with adult acute lymphoblastic leukemia (ALL). Early results from the international ALL trial. [Abstract] Blood 94 (suppl 1): 3071a, 1999.
Goldstone AH, Richards SM, Lazarus HM, Tallman MS, Buck G, Fielding AK, Burnett AK, Chopra R, Wiernik PH, Foroni L, Paietta E, Litzow MR, Marks DI, Durrant J, McMillan A, Franklin IM, Luger S, Ciobanu N, Rowe JM. In adults with standard-risk acute lymphob — View Citation
Goldstone AH. Transplants in Adult ALL--? Allo for everyone. Biol Blood Marrow Transplant. 2009 Jan;15(1 Suppl):7-10. doi: 10.1016/j.bbmt.2008.11.017. — View Citation
Juric D, Lacayo NJ, Ramsey MC, Racevskis J, Wiernik PH, Rowe JM, Goldstone AH, O'Dwyer PJ, Paietta E, Sikic BI. Differential gene expression patterns and interaction networks in BCR-ABL-positive and -negative adult acute lymphoblastic leukemias. J Clin On — View Citation
Lazarus HM, Richards SM, Chopra R, et al.: Adult patients with acute lymphoblastic leukemia (ALL) and central nervous system (CNS) leukemia at diagnosis may attain durable complete remissions (CR). Results from the International ALL Trial (MRC UKALL-XII/E
Lazarus HM, Richards SM, Chopra R, Litzow MR, Burnett AK, Wiernik PH, Franklin IM, Tallman MS, Cook L, Buck G, Durrant IJ, Rowe JM, Goldstone AH; Medical Research Council (MRC)/National Cancer Research Institute (NCRI) Adult Leukaemia Working Party of the — View Citation
Mansour MR, Sulis ML, Duke V, Foroni L, Jenkinson S, Koo K, Allen CG, Gale RE, Buck G, Richards S, Paietta E, Rowe JM, Tallman MS, Goldstone AH, Ferrando AA, Linch DC. Prognostic implications of NOTCH1 and FBXW7 mutations in adults with T-cell acute lymph — View Citation
Marks DI, Paietta EM, Moorman AV, Richards SM, Buck G, DeWald G, Ferrando A, Fielding AK, Goldstone AH, Ketterling RP, Litzow MR, Luger SM, McMillan AK, Mansour MR, Rowe JM, Tallman MS, Lazarus HM. T-cell acute lymphoblastic leukemia in adults: clinical f — View Citation
Moorman AV, Harrison CJ, Buck GA, Richards SM, Secker-Walker LM, Martineau M, Vance GH, Cherry AM, Higgins RR, Fielding AK, Foroni L, Paietta E, Tallman MS, Litzow MR, Wiernik PH, Rowe JM, Goldstone AH, Dewald GW; Adult Leukaemia Working Party, Medical Re — View Citation
Moorman AV, Schwab C, Ensor HM, Russell LJ, Morrison H, Jones L, Masic D, Patel B, Rowe JM, Tallman M, Goldstone AH, Fielding AK, Harrison CJ. IGH@ translocations, CRLF2 deregulation, and microdeletions in adolescents and adults with acute lymphoblastic l — View Citation
Paietta E, Ferrando AA, Neuberg D, Bennett JM, Racevskis J, Lazarus H, Dewald G, Rowe JM, Wiernik PH, Tallman MS, Look AT. Activating FLT3 mutations in CD117/KIT(+) T-cell acute lymphoblastic leukemias. Blood. 2004 Jul 15;104(2):558-60. doi: 10.1182/blood-2004-01-0168. Epub 2004 Mar 25. — View Citation
Paietta E, Kim H, Racevskis J, et al.: Immunophenotypic characteristics, but not age or secondary cytogenetic changes, affect response and survival of BCR/ABL positive adult acute lymphoblastic leukemia (ALL): ECOG/MRC Intergroup trial, E2993. [Abstract]
Paietta E, Kim H, Rowe JM, et al.: Prognostic significance of immunophenotyping and cytogenetics in adult acute lymphoblastic leukemia (ALL): interim analysis of ECOG/MRC phase III intergroup trial, E2993. [Abstract] Blood 98 (11 Pt 1): A-3494, 2001.
Paietta E, Li X, Richards S, et al.: Implications for the use of monoclonal antibodies in future adult ALL trials: analysis of antigen expression in 505 B-lineage (B-Lin) ALL patients (pts) on the MRC UKALLXII/ECOG2993 Intergroup trial. [Abstract] Blood 1
Paietta E, Racevskis J, Neuberg D, Rowe JM, Goldstone AH, Wiernik PH. Expression of CD25 (interleukin-2 receptor alpha chain) in adult acute lymphoblastic leukemia predicts for the presence of BCR/ABL fusion transcripts: results of a preliminary laborator — View Citation
Patel B, Rai L, Buck G, Richards SM, Mortuza Y, Mitchell W, Gerrard G, Moorman AV, Duke V, Hoffbrand AV, Fielding AK, Goldstone AH, Foroni L. Minimal residual disease is a significant predictor of treatment failure in non T-lineage adult acute lymphoblast — View Citation
Patel B, Richards SM, Rowe JM, Goldstone AH, Fielding AK. High incidence of avascular necrosis in adolescents with acute lymphoblastic leukaemia: a UKALL XII analysis. Leukemia. 2008 Feb;22(2):308-12. doi: 10.1038/sj.leu.2405032. Epub 2007 Nov 8. — View Citation
Ramanujachar R, Richards S, Hann I, Goldstone A, Mitchell C, Vora A, Rowe J, Webb D. Adolescents with acute lymphoblastic leukaemia: outcome on UK national paediatric (ALL97) and adult (UKALLXII/E2993) trials. Pediatr Blood Cancer. 2007 Mar;48(3):254-61. doi: 10.1002/pbc.20749. — View Citation
Rowe JM, Buck G, Burnett AK, Chopra R, Wiernik PH, Richards SM, Lazarus HM, Franklin IM, Litzow MR, Ciobanu N, Prentice HG, Durrant J, Tallman MS, Goldstone AH; ECOG; MRC/NCRI Adult Leukemia Working Party. Induction therapy for adults with acute lymphobla — View Citation
Rowe JM, Buck G, Moorman AV, et al.: Standard consolidation/maintenance chemotherapy is consistently superior to a single autologous transplant for adult patients with acute lymphoblastic leukemia: results of the international ALL trial (MRC UKALL XII/ECO
Rowe JM, Richards S, Wiernik PH, et al.: Allogenic bone marrow transplantation (BMT) for adults with acute lymphoblastic leukemia (ALL) in first complete remission (CR): early results from the international ALL trial. [Abstract] Blood 94 (suppl 1): 732a,
Rowe JM, Richards SM, Burnett AK, et al.: Favorable results of allogeneic bone marrow transplantation (BMT) for adults with Philadelphia (Ph)-chromosome-negative acute lymphoblastic leukemia (ALL) in first complete remission (CR): results from the interna
Sive JI, Buck G, Fielding A, Lazarus HM, Litzow MR, Luger S, Marks DI, McMillan A, Moorman AV, Richards SM, Rowe JM, Tallman MS, Goldstone AH. Outcomes in older adults with acute lymphoblastic leukaemia (ALL): results from the international MRC UKALL XII/ — View Citation
Wang H, Chen XQ, Geng QR, Liu PP, Lin GN, Xia ZJ, Lu Y. Induction therapy using the MRC UKALLXII/ECOG E2993 protocol in Chinese adults with acute lymphoblastic leukemia. Int J Hematol. 2011 Aug;94(2):163-168. doi: 10.1007/s12185-011-0891-y. Epub 2011 Jul 6. — View Citation
* Note: There are 32 references in all — Click here to view all references
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