Clinical trial · Interventional
Lenalidomide and Obinutuzumab for Previously Untreated CLL
A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia
NCT02371590CI-TRIAL-00031795withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study Not Activated Due to Contract Issues
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide-Obinutuzumab
- description
- All patients receive the combination of lenalidomide and obinutuzumab. There is no randomization or comparator arm.
- interventionNames
- Drug: Lenalidomide
- Drug: Obinutuzumab
Primary outcomes (2)
- measure
- The incidence of dose limiting toxicity
- timeFrame
- 1 year
- description
- For phase 1 portion of study
- measure
- Complete Response Rate
- timeFrame
- 2 years
- description
- For phase 2 portion of study: iwCLL 2008 defined complete response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.