New drug combo aims to tame blood cancer without chemo
NCT ID NCT01446133
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests lenalidomide and rituximab in 120 people with chronic lymphocytic leukemia or small lymphocytic lymphoma. The goal is to see if this drug combination can control the disease, especially for those who cannot or choose not to have chemotherapy. Participants take lenalidomide daily and receive rituximab infusions over several cycles, with response checked after 3, 6, and 12 cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenalidomide and rituximab
- What this could lead to
- If this works, it could offer a chemotherapy-free option to control CLL/SLL, potentially reducing tumor growth and improving response rates.
- What could go wrong
- This is a mid-stage trial with 120 participants, so results may not apply to everyone. Side effects from the drug combination could occur, and the treatment may not work for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2011
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>/-18 at the time of signing of informed consent.Understand and voluntarily sign informed consent. 2. Patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated CLL/SLL or recurrent disease. Patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine. 3. ECOG/WHO performance status of 0-2. 4. Adequate renal function indicated by serum creatinine less or equal to 2mg/dL 5. Adequate hepatic function indicated as total bilirubin less or equal to 2mg/dL and ALT less or equal to 2 times the upper limit of normal. 6. Disease free of prior malignancies for 3 years with exception of current basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received. 7. All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the program requirements. 8. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1. Prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use two acceptable methods of birth control, one highly effective method and one additional effective method at the same time at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. Exclusion Criteria: 1. Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab. 2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood). 3. Known positivity for HIV or active hepatitis B or C. 4. Pregnant or breast feeding females. 5. History of tuberculosis treated within the last five years or recent exposure to tuberculosis. 6. Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study. 7. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to enrollment are not eligible for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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