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Drug combo aims to control Slow-Growing lymphoma without chemo

NCT ID NCT01316523

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a combination of two drugs, lenalidomide and rituximab, in 30 people with previously untreated indolent non-Hodgkin's lymphoma. The goal was to see how well the drugs worked together to shrink or control the cancer. Participants took lenalidomide daily for three weeks out of four, plus rituximab infusions, and the study measured how many patients responded to treatment.

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 successful, this combination could offer a chemotherapy-free option to control indolent non-Hodgkin's lymphoma and delay the need for more aggressive treatment.
What could go wrong
This was a small, early-phase trial that was terminated, so results are limited. Lenalidomide can cause serious side effects like blood clots and low blood counts.

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

30 people

The number who actually took part.

Started

Dec 2010

Finished

Apr 2024

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: 1. All patients must be informed of the investigative nature of the clinical trial and given written informed consent in accordance with institutional and federal guidelines. 2. Age greater than or equal to 18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Previously untreated, histologically confirmed indolent lymphoma including follicle cell lymphoma, WHO classification, grade I or II, and marginal zone lymphoma. Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine needle aspirates are not acceptable. 5. At least one measurable lesion according to the International Working Group Response criteria for lymphomas. There must be measurable lymphadenopathy to follow with serial exam and/or imaging. 6. Submission of original biopsy for review by local staff hematopathologist. 7. ECOG performance status of 0 -2 at study entry. 8. No major organ dysfunction with laboratory test results within these ranges: * Absolute neutrophil count greater than or equal to 1000 /uL * Platelet count greater than or equal to 75 x 109/L * Total bilirubin less than or equal to 2.0 mg/dL. * HIV negative * Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥ 30ml/min and \< 60ml/min. 9. Life expectancy of greater than 3 months. 10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin 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. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. 11. Disease free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast 12. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients who are intolerant to aspirin may use low molecular weight heparin). 13. Must be able to swallow lenalidomide capsules. Exclusion Criteria: 1. Any prior treatment for Non-Hodgkin's Lymphoma. 2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 3. Pregnant or breast-feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 5. Use of any other experimental drug or therapy within 28 days of baseline. 6. Known hypersensitivity to thalidomide or rituximab. 7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 8. Any prior use of lenalidomide. 9. Concurrent use of other anti-cancer agents or treatments. 10. Known positive for HIV 11. Known active hepatitis, type A, B or C. 12. Evidence for CNS metastatic disease 13. Subjects with ≥ Grade 2 neuropathy

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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

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403, United States

  • University of California Davis Cancer Center

    Sacramento, California, 95817, United States

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