New cocktail aims to wipe out CLL early
NCT ID NCT01723839
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a combination of chemotherapy (FCR) plus the drug lenalidomide in 21 people with previously untreated chronic lymphocytic leukemia (CLL). The goal was to see if adding lenalidomide could help more patients achieve a complete response, meaning no signs of cancer remain. Participants received 4 to 6 cycles of the combo, followed by lenalidomide alone as maintenance. The study is now complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FCR chemotherapy (fludarabine, cyclophosphamide, rituximab) plus lenalidomide
- What this could lead to
- If successful, this combination could improve the chance of wiping out all signs of CLL after initial treatment, potentially leading to longer remission without needing ongoing therapy.
- What could go wrong
- This is a small, early-phase trial with only 21 people, so results may not apply to everyone. The treatment can cause serious side effects like low white blood cell counts (neutropenia), and lenalidomide may add extra risks.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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21 people
The number who actually took part.
- Started
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Feb 2012
- Finished
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Jun 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Patients must have diagnosis of CLL (as defined by the NCI Criteria below: * Patients must have peripheral blood absolute lymphocyte count of \>5,000/mm3 obtained within 2 weeks prior to start of study. * The lymphocytosis must consist of small, mature lymphocytes, with ≤55% (not greater than 55%) prolymphocytes. * Patients must have phenotypically characterized CLL as defined as: 1. The predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.); 2. Surface immunoglobulin (slg) and CD20 with low-cell surface density expression. 3. If surface immunoglobulin can be demonstrated, the leukemic cells are restricted to expression of either kappa or lambda. * Splenomegaly, hepatomegaly or lymphadenopathy are not required for the diagnosis of CLL * Patients must require chemotherapy * Patients must not have received prior treatment cytotoxic, immunotherapy or investigational therapy. * Patients must not have history of corticosteroid treatment for CLL, Autoimmune thrombocytopenia, or autoimmune hemolytic anemia. * Calculated creatinine clearance ≥30ml/min by Cockcroft-Gault formula * Bilirubin must be ≤1.5mg/dl, unless secondary to tumor, obtained within 2 weeks prior to registration * Platelets ≥75x109/L, unless due to CLL involvement of bone marrow * Neutrophils ≥1.5x109/L, unless due to CLL involvement of bone marrow * AST or ALT \< 2x upper limit of normal, unless related to CLL * Age ≥18 years * ECOG performance status 0-2 * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy * Able to take aspirin (81mg or 325mg) daily as prophylactic anticoagulation * Subject must provide written informed consent * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® Exclusion Criteria: * Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia are not eligible * No prior immunotherapy, investigational or cytotoxic chemotherapy * Patients with a history of steroid treatment for CLL/SLL autoimmune hemolytic anemia, or autoimmune thrombocytopenia are not eligible * Patients with active infections requiring oral or intravenous (IV) antibiotics until resolution of the infection and completion of therapeutic antibiotics * Women of childbearing potential and sexually active males who both refuse to use an accepted and effective method of contraception or women who are breastfeeding * Patients with a second malignancy other than basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible unless the tumor was treated with curative intent at least two years previously * History of known HIV * History or presence CNS disease * Evidence of laboratory TLS by Cairo-Bishop definition of Tumor Lysis Syndrome * History of corticosteroid treatment for CLL, Autoimmune thrombocytopenia, or autoimmune hemolytic anemia.
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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
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John Theurer Cancer Center at HackensackUMC
Hackensack, New Jersey, 07601, United States
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Other studies related to the condition(s) this trial covers.
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