Clinical trial · Interventional
Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia
Lenalidomide for the Treatment of CLL Patients With High-Risk Disease
NCT01271283CI-TRIAL-00018137withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Conditions
Conditions (3)
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 |
| Stage III Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage IV Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.
- interventionNames
- Other: Diagnostic Laboratory Biomarker Analysis
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months
Secondary outcomes (1)
- measure
- Maximal clinical response (complete and partial response)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
* Must have high-risk B-CLL as defined by ≥ one of the following:
* High-risk cytogenetics (either 17p deletion and/or 11q deletion)
* Unmutated immunoglobulin heavy chain gene rearrangement
* Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
* No prior treatment for the management of B-CLL
* Patients must have B-CLL requiring therapy as defined by the IWCLL criteria
* Must have measurable disease meeting one of the following criteria:
* Absolute lymphocyte count \> 5,000/μL
* Measurable lymphadenopathy or organomegaly
* No tumor lysis syndrome (TLS) by Cairo-Bishop definition
* Patients with correction of electrolyte abnormalities allowed
* ECOG performance status 0-2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* Creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)
* Uric acid normal
* Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide
* Able to adhere to the study visit schedule and other protocol requirements
* No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
* No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* No known hypersensitivity to thalidomide or lenalidomide
* No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
* No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for \> 3 years
* No cardiac arrest within the past 6 months
* No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody
* No other concurrent anti-cancer agents or treatments
* More than 28 days since any prior experimental drug or therapy
* Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required
* No prior lenalidomideReferences
Publications (0)
Data not yet available
No reference posted for this study.