- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01246076
Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents
Phase II Trial of High Dose Lenalidomide in Patients With Myelodysplastic Syndrome Refractory to Hypomethylating Agents
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Arizona
-
Scottsdale, Arizona, Förenta staterna
- Mayo Clinic Scottsdale AZ
-
-
Missouri
-
St. Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patient must be able to understand and voluntarily sign an informed consent form.
- Patient must be ≥ 18 years old.
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
Patient must have histologically confirmed Myelodysplastic Syndrome as defined by FAB Classification including CMML and secondary MDS which has either:
- progressed at any time during treatment with hypomethylating agents
- failed to achieve a response after 6 cycles
- progressed after treatment with hypomethylating agents had been discontinued Criteria for response and for progression as defined by revised IWG criteria
- Patient must have discontinued all previous cancer therapy, including radiation, hormonal therapy and surgery at least 4 weeks prior to treatment in this study.
- Patient must have an ECOG performance status of ≤ 2 at study entry
Patient must have laboratory test results within these ranges:
- calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
- total bilirubin ≤ 1.5 x ULN
- AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
- Patient must be disease free of prior malignancies for at least 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- Patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®.
- If a female of childbearing potential (FCBP), patient must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to initiation of therapy and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days).
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
-If a FCBP, patient must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed
Exclusion Criteria:
- Patient must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Patient must not be pregnant or breastfeeding.
- Patient must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Patient must not use any other experimental drug or therapy within 28 days of baseline.
- Patient must not have a known hypersensitivity to thalidomide.
- Patient must not have developed of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Patient must not have any prior use of lenalidomide.
- Patient must not be concurrently using other anti-cancer agents or treatments.
- Patient must not have known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Lenalidomide
Lenalidomide 50 mg/day for two 28 day cycles. Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles. |
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria
Tidsram: Up to 56 weeks (14 cycles of treatment)
|
|
Up to 56 weeks (14 cycles of treatment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall Survival Rate
Tidsram: 6 months after end of treatment (up to 82 weeks from start of treatment)
|
-Overall survival rate is the percentage of participants who were alive 6 months after end of treatment.
|
6 months after end of treatment (up to 82 weeks from start of treatment)
|
Duration of Response
Tidsram: Until 6 months after end of treatment
|
Until 6 months after end of treatment
|
|
Time to Discontinuation of Treatment
Tidsram: Up to 56 weeks (14 cycles)
|
Up to 56 weeks (14 cycles)
|
|
Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4
Tidsram: 30 days after end of treatment (up to 60 weeks)
|
30 days after end of treatment (up to 60 weeks)
|
|
Time to Progression
Tidsram: Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)
|
The time to progression is defined as the time from registration to the date of progression or last follow-up.
Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.
|
Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer
- Sjukdom
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Precancerösa tillstånd
- Syndrom
- Myelodysplastiska syndrom
- Preleukemi
- Läkemedels fysiologiska effekter
- Antineoplastiska medel
- Immunologiska faktorer
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Lenalidomid
Andra studie-ID-nummer
- 201011810
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Myelodysplastiska syndrom
-
M.D. Anderson Cancer CenterHar inte rekryterat ännuMyeloproliferativ neoplasma | Myelodysplastisk neoplasma | Pathway Mutant Myelodysplastic SyndromeFörenta staterna
-
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
-
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
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)AvslutadTidigare behandlade myelodysplastiska syndrom | Sekundära myelodysplastiska syndrom | de Novo myelodysplastiska syndromFörenta staterna
-
National Cancer Institute (NCI)AvslutadTidigare behandlade myelodysplastiska syndrom | Sekundära myelodysplastiska syndrom | de Novo myelodysplastiska syndromFörenta staterna
-
TJ Biopharma Co., Ltd.Rekrytering
-
National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RekryteringMyelodysplastiska syndrom (MDS)Förenta staterna, Israel
-
AbbVieCelgene; Genentech, Inc.AvslutadMyelodysplastiska syndrom (MDS)Förenta staterna, Australien, Tyskland
-
AbbVieGenentech, Inc.Aktiv, inte rekryterandeMyelodysplastiska syndrom (MDS)Förenta staterna, Australien, Kanada, Frankrike, Tyskland, Italien, Storbritannien
-
The First Affiliated Hospital with Nanjing Medical...OkändMyelodysplastiska syndrom (MDS)Kina
Kliniska prövningar på Lenalidomid
-
Sidney Kimmel Comprehensive Cancer Center at Johns...AvslutadMyelodysplastiskt syndromFörenta staterna
-
Celgene CorporationICON Clinical ResearchAvslutadMyelodysplastiska syndromTyskland, Israel, Storbritannien, Spanien, Belgien, Italien, Frankrike, Nederländerna, Sverige
-
Grupo Español de Linfomas y Transplante Autólogo...Celgene Corporation; Dynamic Science S.L.; Thermo Fisher Scientific, IncAvslutad
-
Boston VA Research Institute, Inc.Celgene Corporation; Edward Hines Jr. VA Hospital; Michael E. DeBakey VA... och andra samarbetspartnersAvslutadMultipelt myelomFörenta staterna
-
Swiss Group for Clinical Cancer ResearchAvslutadLymfomSchweiz, Norge, Sverige
-
Groupe Francophone des MyelodysplasiesOkändMyelodysplastiska syndromFrankrike
-
Dana-Farber Cancer InstituteBeth Israel Deaconess Medical Center; Genentech, Inc.; Brigham and Women's... och andra samarbetspartnersAvslutadWaldenströms makroglobulinemiFörenta staterna
-
Poitiers University HospitalAvslutadMultipelt myelom | Nedsatt njurfunktionFrankrike
-
European Organisation for Research and Treatment...AvslutadLymfomÖsterrike, Belgien, Spanien, Frankrike, Storbritannien, Tyskland, Finland, Schweiz