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New cocktail aims to wipe out CLL early

NCT ID NCT01723839

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Feb 2012

Finished

Jun 2021

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

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

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

  • John Theurer Cancer Center at HackensackUMC

    Hackensack, New Jersey, 07601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.