- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00577694
Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Nonrandomized Dose-escalation Study of Clofarabine in Combination With Gemtuzumab Ozogamicin for Relapsed/Refractory Acute Myeloid Leukemia (AML) for Patients Less Than 60 Years-old
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid leukemia.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Identify the maximum tolerated dose and dose-limiting toxicities of clofarabine when administered with gemtuzumab ozogamicin in patients with refractory acute myeloid leukemia (AML) or with AML that has relapsed within 1 year after cytarabine-containing therapy.
Secondary
- Estimate the rates of complete response and/or partial complete response with incomplete platelet recovery in patients treated with this regimen.
- Estimate the duration of remission in patients treated with this regimen and not proceeding to high-dose therapy and allogeneic stem cell transplantation.
- Estimate the frequency with which patients enrolled on this study proceed to allogeneic or autologous blood or bone marrow stem cell transplantation.
OUTLINE: This is a dose-escalation study of clofarabine.
Patients receive induction therapy comprising clofarabine IV on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on days 1, 4, and 7 during course 1 only. Beginning in course 2, after blood counts recover, patients receive consolidation therapy comprising clofarabine IV on days 1-5. Consolidation treatment repeats upon blood count recovery for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients in remission after consolidation therapy are followed monthly for the first 6 months, and then every 3-4 months for 2 years.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
- Refractory disease, defined as persistent or progressive disease after ≥ 2 induction regimens, including ≥ 1 course of high-dose cytarabine (ARA-C)
- Relapsed disease that has recurred within 1 year of an ARA-C-containing chemotherapy regimen
No CNS disease requiring radiotherapy
- Patients with neurological symptoms must undergo a lumbar puncture and a CT scan or MRI of the brain to exclude brain metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- ALT and AST ≤ 2.0 times the ULN
- Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min
INR ≤ 1.5 and aPTT within ULN
- Patients receiving anticoagulation therapy (e.g., warfarin or heparin) are eligible provided anticoagulation therapy can be discontinued or changed to parenteral medications while the platelet count is less than 50,000/mm³
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent active second primary malignancy (excluding superficial, non-invasive skin cancers)
- No active bleeding diathesis, not including closely monitored therapeutic anticoagulation
No cardiac disease, including any of the following:
- New York Heart Association class II-IV congestive heart failure
- Unstable angina (i.e., anginal symptoms at rest)
- New onset angina (i.e., began within the past 3 months)
- Myocardial infarction within the past 6 months
- No active clinically serious infection > grade 2
- No cerebrovascular accident, including transient ischemic attacks, within the past 6 months
- No pulmonary hemorrhage ≥ grade 2 within the past 4 weeks
- No other hemorrhage or bleeding event ≥ grade 3 within the past 4 weeks
- No known HIV infection or chronic hepatitis B or C
- No serious non-healing wound or ulcer
- More than 4 weeks since prior significant traumatic injury
- No prior history of sinusoidal obstructive syndrome (veno-occlusive disease)
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior major surgery or open biopsy
- More than 100 days since any prior hematopoietic stem cell transplant
No concurrent treatment with any other investigational agent for AML
- Intrathecal chemotherapy administration is allow for central nervous system leukemic infiltration
- No prior allogeneic stem cell transplant within the past 100 days, with active graft-versus-host disease (GVHD) of any grade, or exposure to immynosuppression for GVHD or prophylaxis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: single arm study
1
|
Intravenous, 20mg/m2, Days 1, 2, 3, 4 and 5; 2 cycles
Andre navn:
Intravenous, 3mg/m2, Day 1, one cycle
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum tolerated dose of clofarabine
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rate of complete response and/or partial complete response with incomplete platelet recovery
Tidsramme: 3 years
|
3 years
|
Duration of remission
Tidsramme: 5 years
|
5 years
|
Frequency of patients proceeding to allogeneic or autologous blood or bone marrow stem cell transplantation
Tidsramme: 5 years
|
5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Thomas C. Shea, MD, UNC Lineberger Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LCCC 0708
- P30CA016086 (U.S. NIH-stipend/kontrakt)
- CDR0000580801 (Annen identifikator: PDQ number)
- UNC-LCCC-07-1222
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Leukemi
-
Massachusetts General HospitalCelgene CorporationAvsluttetAkutt myelogen leukemi | Akutt myeloid leukemi (AML) | Akutt myelocytisk leukemi | Akutt granulocytisk leukemi | Akutt ikke-lymfocytisk leukemiForente stater
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for...RekrutteringIldfast leukemi | Tilbakefallende leukemi | Akutt myeloid leukemi, barndomKina
-
Betta Pharmaceuticals Co., Ltd.Har ikke rekruttert ennåAkutt Myeloid Leukemi LeukemiKina
-
GlaxoSmithKlineAvsluttetLeukemi, Myelocytisk, AkuttForente stater, Australia, Canada
-
Hybrigenics CorporationUkjentAkutt myelogen leukemiForente stater, Frankrike
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationAktiv, ikke rekrutterendeAkutt myelogen leukemiForente stater
-
Massachusetts General HospitalFullført
-
Beijing Boren HospitalRekrutteringAkutt myeloid leukemi | Refraktær Akutt Myeloid Leukemi | Tilbakefall leukemiKina
-
Kinex Pharmaceuticals Inc.FullførtAkutt myelogen leukemiForente stater
-
Children's Oncology GroupNational Cancer Institute (NCI)FullførtAkutt monoblastisk leukemi i barndom (M5a) | Akutt monocytisk leukemi i barndom (M5b) | Akutt myeloblastisk leukemi i barndom uten modning (M1) | Akutt myelomonocytisk leukemi i barndommen (M4) | Barndom Akutt Myeloid Leukemi/Andre Myeloid MaligniteterForente stater
Kliniske studier på clofarabine
-
UNC Lineberger Comprehensive Cancer CenterGenzyme, a Sanofi CompanyFullførtAkutt myeloid leukemi | Kronisk myelomonocytisk leukemi | Akutt lymfatisk leukemi | Myelodysplastisk syndromForente stater
-
Baylor Research InstituteGenzyme, a Sanofi CompanyFullførtLeukemi | Myelodysplastisk syndromForente stater
-
Jonsson Comprehensive Cancer CenterAvsluttetOndartet neoplasmaForente stater
-
Jonsson Comprehensive Cancer CenterFullførtLeddgikt | Systemisk lupus erythematosus | Crohns sykdom | Takayasu arteritt | Autoimmun sykdom | Inflammatorisk lidelseForente stater
-
Washington University School of MedicineAvsluttetMultippelt myelomForente stater
-
Ohio State University Comprehensive Cancer CenterFullførtNon-Hodgkins lymfomForente stater
-
M.D. Anderson Cancer CenterGenzyme, a Sanofi CompanyFullført
-
Dana-Farber Cancer InstituteTilbaketrukketLangerhans cellehistiocytose
-
Baylor Research InstituteFullførtMyelodysplastiske syndromer | Akutt myelogen leukemi | Kronisk myelogen leukemiForente stater
-
Dana-Farber Cancer InstituteSanofi; North American Consortium for Histiocytosis; St. Baldrick's Foundation og andre samarbeidspartnereAktiv, ikke rekrutterendeLangerhans cellehistiocytoseForente stater, Canada