- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00003545
506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)
Panoramica dello studio
Descrizione dettagliata
OBJECTIVES:
I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5).
II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.
OUTLINE:
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Mobile, Alabama, Stati Uniti, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Stati Uniti, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Stati Uniti, 85724
- Arizona Cancer Center
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Tucson, Arizona, Stati Uniti, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Stati Uniti, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Stati Uniti, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Long Beach, California, Stati Uniti, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stati Uniti, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Stati Uniti, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Stati Uniti, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Stati Uniti, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Stati Uniti, 95403
- CCOP - Santa Rosa Memorial Hospital
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Stanford, California, Stati Uniti, 94305
- Stanford University
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Travis Air Force Base, California, Stati Uniti, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Stati Uniti, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Stati Uniti, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Stati Uniti, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, Stati Uniti, 62526
- CCOP - Central Illinois
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Hines, Illinois, Stati Uniti, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Stati Uniti, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Stati Uniti, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Stati Uniti, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Stati Uniti, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Stati Uniti, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Stati Uniti, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
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Detroit, Michigan, Stati Uniti, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Stati Uniti, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Stati Uniti, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Stati Uniti, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Stati Uniti, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Stati Uniti, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Stati Uniti, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Stati Uniti, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Stati Uniti, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Stati Uniti, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Stati Uniti, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stati Uniti, 43206
- CCOP - Columbus
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Dayton, Ohio, Stati Uniti, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Stati Uniti, 45429
- CCOP - Dayton
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Toledo, Ohio, Stati Uniti, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oklahoma City, Oklahoma, Stati Uniti, 73190
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Stati Uniti, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Stati Uniti, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Stati Uniti, 97201-3098
- Oregon Cancer Center
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, Stati Uniti, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Sam Houston, Texas, Stati Uniti, 78234
- Brooke Army Medical Center
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Galveston, Texas, Stati Uniti, 77555-0209
- University of Texas Medical Branch
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Lubbock, Texas, Stati Uniti, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Stati Uniti, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Stati Uniti, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Stati Uniti, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Stati Uniti, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Stati Uniti, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Stati Uniti, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Stati Uniti, 98104
- Swedish Cancer Institute
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Seattle, Washington, Stati Uniti, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Stati Uniti, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Stati Uniti, 98405-0986
- CCOP - Northwest
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
- Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8
- Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13
- Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission
- No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy
PATIENT CHARACTERISTICS:
- Age: 16 and over
- Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
- Creatinine clearance at least 50 mL/min (unless due to leukemia)
- No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL
- No preexisting neuropathy of grade 2 or greater regardless of causality
- No history of seizure disorder
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No concurrent erythropoietin
- No other concurrent chemotherapy
- No concurrent dexamethasone or other steroidal antiemetics
- No concurrent hormone therapy, except for non-disease-related conditions
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Arm I
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5.
If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78.
If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response.
For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days.
Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Steven E. Coutre, MD, Stanford University
- Cattedra di studio: Daniel DeAngelo, MD, PhD, Dana-Farber Cancer Institute
Pubblicazioni e link utili
Pubblicazioni generali
- DeAngelo DJ, Yu D, Johnson JL, Coutre SE, Stone RM, Stopeck AT, Gockerman JP, Mitchell BS, Appelbaum FR, Larson RA. Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801. Blood. 2007 Jun 15;109(12):5136-42. doi: 10.1182/blood-2006-11-056754. Epub 2007 Mar 7.
- De Angelo DJ, Yu D, Dodge RK, et al.: A phase II study of 2-amino-9-b-D-arabinosyl-6-methoxy-9H-purine (506U78) in patients with relapsed or refractory T-Lineage acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL): CALGB study 19801. [Abstract] Blood 100 (11 Pt 1): A-743, 2002.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- linfoma linfoblastico ricorrente dell'adulto
- leucemia/linfoma a cellule T dell'adulto ricorrente
- leucemia linfoblastica acuta ricorrente dell'adulto
- leucemia linfoblastica acuta infantile ricorrente
- linfoma linfoblastico infantile ricorrente
- Leucemia linfoblastica acuta infantile a cellule T
- Leucemia linfoblastica acuta dell'adulto a cellule T
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCI-2012-01840
- CLB-19801
- SWOG-C19801
- CDR0000066600 (Altro numero di sovvenzione/finanziamento: PDQ (Physician Data Query))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .