- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00077558
3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
A Phase I Trial Of Sequential Administration Of Triapine (3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone) Followed By Fludarabine In Adults With Relapsed And Refractory Leukemias And Myelodysplasias
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given together with 3-AP in treating patients with relapsed or refractory acute leukemia, chronic leukemia, or high-risk myelodysplastic syndrome.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Determine the feasibility and tolerability of 3-AP (Triapine^® ) followed by fludarabine in patients with relapsed or refractory acute or chronic leukemia or high-risk myelodysplastic syndromes.
- Determine the toxic effects of this regimen in these patients.
- Determine the maximum tolerated dose of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of fludarabine. Patients are stratified according to disease (acute leukemias and myelodysplastic syndromes [MDS] vs chronic lymphocytic leukemia and prolymphocytic leukemia). Patients are assigned to 1 of 2 treatment groups.
- Group 1 (chronic lymphocytic leukemia or prolymphocytic leukemia): Patients receive 3-AP (Triapine^®) IV over 4 hours and fludarabine IV over 30 minutes on days 1-5.
Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.
- Group 2 (acute leukemias or MDS): Patients receive 3-AP IV continuously over 24 hours on day 1. Beginning within 4 hours after completion of 3-AP, patients receive fludarabine IV over 30 minutes on days 2-6.
In both groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 3-34 patients will be accrued for this study.
Studietyp
Fas
- Fas 1
Kontakter och platser
Studieorter
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342-4777
- Blood and Marrow Transplant Group of Georgia
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Maryland
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Baltimore, Maryland, Förenta staterna, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Förenta staterna, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Texas
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Houston, Texas, Förenta staterna, 77030-4095
- M.D. Anderson Cancer Center at University of Texas
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
High-risk myelodysplastic syndromes (MDS), including refractory anemia with excess blasts and chronic myelomonocytic leukemia
International Prognostic Scoring System (IPSS) score at least 1.5 based on the following:
- More than 10% marrow blasts
- Cytopenias in at least 2 lineages
- Adverse cytogenetics
Acute myeloid leukemia (AML)
- All subtypes, including MDS/AML and treatment-related (secondary) AML
- Acute lymphoblastic leukemia
Acute progranulocytic leukemia
- Ineligible for arsenic therapy
Chronic myelogenous leukemia
- Accelerated phase or blastic crisis
- Chronic lymphocytic leukemia
- Prolymphocytic leukemia
- Received or ineligible for established curative regimens, including stem cell transplantation
- Acute and chronic leukemias must be relapsed and/or refractory with progressive disease since last therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- No history of hemolytic anemia grade 2 or greater
No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- G6PD screening required for high-risk groups (i.e., patients of African, Asian, or Mediterranean origin/ancestry)
Hepatic
- SGOT and SGPT no greater than 2.5 times normal
- Bilirubin no greater than 2 mg/dL
- No chronic hepatitis
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No active heart disease
- No myocardial infarction within the past 3 months
- No severe coronary artery disease
- No arrhythmias (other than atrial flutter or fibrillation) requiring medication
- No uncontrolled congestive heart failure
Pulmonary
- No dyspnea at rest or with minimal exertion
- No severe pulmonary disease requiring supplemental oxygen
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy grade 2 or greater
No active uncontrolled infection
- Infections under active treatment and controlled by antibiotics are allowed
- No other life-threatening illness
- No psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 1 week since prior hematopoietic growth factor (e.g., epoetin alfa, filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-3, and interleukin-11)
- No concurrent immunotherapy
Chemotherapy
- Recovered from prior chemotherapy (no greater than grade 1 chronic toxic effects)
- At least 72 hours since prior hydroxyurea
- At least 3 weeks since prior myelosuppressive cytotoxic agents (6 weeks for mitomycin or nitrosoureas)
- No more than 12 prior courses of fludarabine
- No more than 3 prior cytotoxic chemotherapy regimens
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 1 week since prior non-myelosuppressive treatment
- No more than 4 prior induction regimens
- No other concurrent therapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- refraktär anemi med överskott av blaster
- kronisk myelomonocytisk leukemi
- tidigare behandlade myelodysplastiska syndrom
- sekundära myelodysplastiska syndrom
- akut myeloid leukemi hos vuxna med 11q23 (MLL) abnormiteter
- akut myeloid leukemi hos vuxna med inv(16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(15;17)(q22;q12)
- akut myeloid leukemi hos vuxna med t(16;16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(8;21)(q22;q22)
- sekundär akut myeloid leukemi
- återkommande akut myeloid leukemi hos vuxna
- atypisk kronisk myeloisk leukemi
- myelodysplastisk/myeloproliferativ sjukdom, oklassificerbar
- akut erytroid leukemi hos vuxna (M6)
- akut megakaryoblastisk leukemi hos vuxna (M7)
- vuxen akut minimalt differentierad myeloid leukemi (M0)
- akut monoblastisk leukemi hos vuxna (M5a)
- akut monocytisk leukemi hos vuxna (M5b)
- akut myeloblastisk leukemi hos vuxna med mognad (M2)
- akut myeloblastisk leukemi hos vuxna utan mognad (M1)
- akut myelomonocytisk leukemi hos vuxna (M4)
- akut basofil leukemi hos vuxna
- akut eosinofil leukemi hos vuxna
- blastisk fas kronisk myelogen leukemi
- återfallande kronisk myelogen leukemi
- refraktär kronisk lymfatisk leukemi
- återkommande akut lymfatisk leukemi hos vuxna
- prolymfocytisk leukemi
- accelererad fas kronisk myelogen leukemi
- akut promyelocytisk leukemi hos vuxna (M3)
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Sjukdom
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Precancerösa tillstånd
- Syndrom
- Myelodysplastiska syndrom
- Leukemi
- Preleukemi
- Myeloproliferativa störningar
- Myelodysplastiska-myeloproliferativa sjukdomar
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Fludarabin
- Fludarabinfosfat
Andra studie-ID-nummer
- CDR0000352322, J0357
- P30CA006973 (U.S.S. NIH-anslag/kontrakt)
- U01CA070095 (U.S.S. NIH-anslag/kontrakt)
- JHOC-J0357
- NCI-6255
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Kliniska prövningar på Myelodysplastiska syndrom
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M.D. Anderson Cancer CenterHar inte rekryterat ännuMyeloproliferativ neoplasma | Myelodysplastisk neoplasma | Pathway Mutant Myelodysplastic SyndromeFörenta staterna
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M.D. Anderson Cancer CenterAktiv, inte rekryterandeÅterkommande akut myeloid leukemi | Återkommande kronisk myelomonocytisk leukemi | Refraktär Akut Myeloid Leukemi | Refraktär kronisk myelomonocytisk leukemi | Återkommande myelodysplastisk/myeloproliferativ neoplasm | Refractory Myelodysplastic/Myeloproliferative NeoplasmFörenta staterna
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Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.AvslutadTidigare behandlat myelodysplastiskt syndrom | Myelodysplastiskt syndrom | Terapierelaterat myelodysplastiskt syndrom | Sekundärt myelodysplastiskt syndrom | Refraktärt högrisk myelodysplastiskt syndromFörenta staterna
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)AvslutadTidigare behandlade myelodysplastiska syndrom | Sekundära myelodysplastiska syndrom | de Novo myelodysplastiska syndromFörenta staterna
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National Cancer Institute (NCI)AvslutadTidigare behandlade myelodysplastiska syndrom | Sekundära myelodysplastiska syndrom | de Novo myelodysplastiska syndromFörenta staterna
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University of Colorado, DenverRekryteringKlinefelters syndrom | Trisomi X | XYY syndrom | XXXY och XXXXY syndrom | Xxyy syndrom | Xyyy syndrom | Xxxx syndrom | Xxxxx syndrom | Xxxyy syndrom | Xxyyy syndrom | Xyyyy syndrom | Man med sexkromosommosaicismFörenta staterna
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TJ Biopharma Co., Ltd.Rekrytering
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National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RekryteringMyelodysplastiska syndrom (MDS)Förenta staterna, Israel
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AbbVieCelgene; Genentech, Inc.AvslutadMyelodysplastiska syndrom (MDS)Förenta staterna, Australien, Tyskland
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AbbVieGenentech, Inc.Aktiv, inte rekryterandeMyelodysplastiska syndrom (MDS)Förenta staterna, Australien, Kanada, Frankrike, Tyskland, Italien, Storbritannien
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Naoyuki G. Saito, M.D., Ph.D.IndragenAkut myeloid leukemi | Myelodysplastiska syndrom | Kronisk myeloid leukemi | Akut lymfatisk leukemiFörenta staterna
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Nantes University HospitalCyceronHar inte rekryterat ännu
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Emory UniversityAvslutadSicklecellanemi | BenmärgstransplantationFörenta staterna
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University Hospital, CaenCNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, FranceAvslutadObehandlad B-kronisk lymfatisk leukemi eller diffus storcellslymfompatienterFrankrike
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Zhujiang HospitalFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of... och andra samarbetspartnersOkändEn optimal dos av anti-tymoglobulin (ATG) minskar cGVHD men ökar inte leukemiåterfall för Haplo-HSCTLeukemi Återfall | Kronisk graft-versus-värd-sjukdom
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Genzyme, a Sanofi CompanyAvslutadLeukemi, lymfocytisk, kronisk, B-cellFörenta staterna
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University of Illinois at ChicagoAvslutadAkut myeloid leukemi | Polycytemi Vera | Multipelt myelom | Myelofibros | Akut leukemi | Kronisk myelogen leukemi | Aplastisk anemi | Myeloproliferativ sjukdom | Hodgkins sjukdom | Malignt lymfom | Lymfocytisk leukemiFörenta staterna
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Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...AvslutadLymfoproliferativa störningar | Leukemi | Multipelt myelom | Myelodysplastiska sjukdomar | PlasmacelldyskrasiFörenta staterna