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Trial record 39 of 856 for:    LENALIDOMIDE AND Angiogenesis

Lenalidomide and Obinutuzumab for Previously Untreated CLL

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ClinicalTrials.gov Identifier: NCT02371590
Recruitment Status : Withdrawn (Study Not Activated Due to Contract Issues)
First Posted : February 25, 2015
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Celgene Corporation
Genentech, Inc.
Information provided by (Responsible Party):
Michael Choi, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE February 25, 2015
Last Update Posted Date February 23, 2018
Estimated Study Start Date  ICMJE February 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • The incidence of dose limiting toxicity [ Time Frame: 1 year ]
    For phase 1 portion of study
  • Complete Response Rate [ Time Frame: 2 years ]
    For phase 2 portion of study: iwCLL 2008 defined complete response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02371590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Number of patients with adverse events associated with lenalidomide-obinutuzumab [ Time Frame: 2 years ]
  • Progression free survival rate [ Time Frame: 2 years ]
    Progression free survival rate at completion of combination therapy, total progression free survival, and overall survival determined by International Working Group in CLL (iwCLL) criteria
  • Overall response rate [ Time Frame: 2 years ]
    Overall response rate (Complete response + partial response) and stable disease rate (also based on 2008 iwCLL guidelines), also at the time of primary endpoint response assessment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lenalidomide and Obinutuzumab for Previously Untreated CLL
Official Title  ICMJE A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia
Brief Summary This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this setting and induce complete clinical responses.
Detailed Description

This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. The primary endpoint is to determine safety and tolerability of the regimen and determine complete response (CR) to therapy. The secondary endpoints will assess the impact of treatment on progression free and overall survival

Eligible patients will receive obinutuzumab for 6 x 28 day cycles. Patients will also receive lenalidomide orally once daily on days 8-28 of each 28 day cycles. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Lenalidomide

    Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.

    The study consists of a 6 month treatment period with obinutuzumab and lenalidomide, and an indefinite period of treatment with lenalidomide for as long as it is helpful and tolerated by subject.

    Other Name: Revlimid
  • Drug: Obinutuzumab
    Obinutuzumab is administered as follows: Cycle 1: 100mg IV on day 1, 900 mg IV on day 2, 1000mg day 8, 1000 mg on day 15. Cycles 2-6: 1000mg IV on day 1.
    Other Name: Gazyva
Study Arms  ICMJE Experimental: Lenalidomide-Obinutuzumab
All patients receive the combination of lenalidomide and obinutuzumab. There is no randomization or comparator arm.
Interventions:
  • Drug: Lenalidomide
  • Drug: Obinutuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
25
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Main Inclusion Criteria:

    1. Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
    2. Prior therapy: no prior CLL therapy.
    3. Patients must have progressive disease based on 2008 iwCLL definition with one of the following:
  • Symptomatic or progressive splenomegaly
  • Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy
  • Progressive anemia (hemoglobin ≤ 11 g/dL)
  • Progressive thrombocytopenia (platelets ≤ 100 x 109/L)
  • Weight loss > 10% body weight over the preceding 6 month period
  • Fatigue attributable to CLL
  • Fever or night sweats for > 2 weeks without evidence of infection
  • Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 6 months.
  • Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or equivalent anticoagulation as prophylactic medication.
  • All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of REMS.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to starting Revlimid and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.
  • ECOG performance status of 0-2.
  • Adequate hematologic function
  • Adequate renal function
  • Adequate hepatic function

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Women for child-bearing age must obtain a pregnancy test and pregnant or breast feeding females are excluded.
  • Known hypersensitivity to thalidomide or lenalidomide (if applicable), including development of erythema nodosum or a desquamating rash while taking thalidomide or similar drugs.
  • Deep vein thrombosis or superficial thrombophlebitis of any cause on current anticoagulation therapy at the time of screening.
  • Patients who are currently receiving another investigational agent are excluded.
  • Current infection requiring parenteral antibiotics.
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV); or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) based on detectable viral load. Patients who are seropositive because of hepatitis B virus vaccine or passive immunization by intravenous immunoglobulin (IVIG) are eligible.
  • Active malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ).
  • Known central nervous system (CNS) involvement by malignancy.
  • Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
  • Insufficient recovery from surgical-related trauma or wound healing.
  • Impaired cardiac function
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02371590
Other Study ID Numbers  ICMJE 150342/161104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Choi, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE
  • Celgene Corporation
  • Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Michael Choi, MD UC San Diego Moores Cancer Center
PRS Account University of California, San Diego
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP