- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater
- Mayo Clinic Scottsdale AZ
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Missouri
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St. Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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. |
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria
Tidsramme: Up to 56 weeks (14 cycles of treatment)
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Up to 56 weeks (14 cycles of treatment)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival Rate
Tidsramme: 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.
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6 months after end of treatment (up to 82 weeks from start of treatment)
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Duration of Response
Tidsramme: Until 6 months after end of treatment
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Until 6 months after end of treatment
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Time to Discontinuation of Treatment
Tidsramme: Up to 56 weeks (14 cycles)
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Up to 56 weeks (14 cycles)
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Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4
Tidsramme: 30 days after end of treatment (up to 60 weeks)
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30 days after end of treatment (up to 60 weeks)
|
|
Time to Progression
Tidsramme: Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)
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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.
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Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Syndrom
- Myelodysplastiske syndromer
- Præleukæmi
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Lenalidomid
Andre undersøgelses-id-numre
- 201011810
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