Lenalidomide and Obinutuzumab for Previously Untreated CLL

NCT02371590 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 150342/161104
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

cancer; lenalidomide; obinutuzumab; CLL

Outcome Measures

Primary Outcomes (2)

• The incidence of dose limiting toxicity

  For phase 1 portion of study

  1 year

• Complete Response Rate

  For phase 2 portion of study: iwCLL 2008 defined complete response rate

  2 years

Secondary Outcomes (3)

• Number of patients with adverse events associated with lenalidomide-obinutuzumab

  2 years

• Progression free survival rate

  2 years

• Overall response rate

  2 years

Study Arms (1)

Lenalidomide-Obinutuzumab

EXPERIMENTAL

All patients receive the combination of lenalidomide and obinutuzumab. There is no randomization or comparator arm.

Drug: Lenalidomide; Drug: Obinutuzumab

Interventions

Lenalidomide DRUG

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.

Also known as: Revlimid

Lenalidomide-Obinutuzumab

Obinutuzumab DRUG

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.

Also known as: Gazyva

Lenalidomide-Obinutuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
• Prior therapy: no prior CLL therapy.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Celgene Corporation: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms

Interventions

Lenalidomide; obinutuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael Choi, MD

  UC San Diego Moores Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)