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New drug combo shows early promise for recurrent lymphoma

NCT ID NCT01644799

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested two drugs, lenalidomide and idelalisib, in 8 people with follicular lymphoma that had returned after previous treatment. Lenalidomide helps the immune system fight cancer, while idelalisib blocks enzymes that cancer cells need to grow. The main goal was to find the safest dose and check for side effects.

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 idelalisib
What this could lead to
If this combination proves safe and effective, it could offer a new treatment option for people with recurrent follicular lymphoma.
What could go wrong
This is a very early, small phase I trial with only 8 participants, so results may not apply broadly. The main goal is safety, not yet effectiveness.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Aug 2013

Finished

May 2017

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.

* Documentation of Disease * Previously treated, histologically confirmed follicle center cell lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (\> 15 centroblasts per high-power field with centrocytes present) * Bone marrow biopsies as the sole means of diagnosis are not acceptable; fine-needle aspirates are not acceptable for diagnosis * Confirmed Cluster of Differentiation 20 (CD20) antigen expression by flow cytometry or immunohistochemistry * Measurable disease must be \> 1 cm * Prior treatment * Patient must have had prior treatment with rituximab either alone or in combination with chemotherapy. * Last prior treatment regimen need not include rituximab. * Patient must have a time to progression of ≥ 6 months from last rituximab dose of last rituximab containing regimen. * No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent * Patients must be 18 years of age or older. * Human immunodeficiency virus (HIV) Infection * Patients with HIV infection are eligible, provided they meet the following: * CD4+ cell count \> 350/mm\^3 * Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load \< 50 copies/mm\^3 * No history of Acquired Immunodeficiency Syndrome (AIDS)-defining conditions or other HIV related illness * No concurrent zidovudine or stavudine because of overlapping toxicities with protocol therapy * Patients must not have known central nervous system (CNS) involvement * Patients must not have known positivity for hepatitis B, as evidenced by + HBsAG or anti-HBc and must not have known history of hepatitis C * Patients must not have any currently active secondary malignancy except non-melanoma skin cancer. Patients are not considered to have a "currently active" secondary malignancy if they have completed anticancer therapy and are deemed to have \< 30% risk of relapse by their physician. * Patients must not have had deep vein thrombosis or pulmonary embolism within the past 3 months. * Patients must not have had radioimmunotherapy within 12 months of study entry. * Patients must not have other concurrent investigational or commercial agents or therapies for lymphoma. * Patients must not have current dialysis treatment. * Patients must be non-pregnant and non-nursing. * Females of Child Bearing Potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (eg, has had menses at any time preceding 24 consecutive months) * FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to registration * FCBP 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 starting lenalidomide * FCBP must also agree to ongoing pregnancy testing * Men must agree to use a latex condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy * CYP3A4 Strong Inducers and Inhibitors * Patients must not be on strong CYP3A4 inhibitors and/or inducers. * Strong inhibitors are prohibited: indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone * Strong inducers are prohibited: carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort, troglitazone * Required Initial Laboratory Values * Absolute neutrophil count (ANC) ≥ 1,000 mm³ * Total Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert disease or lymphoma) * Creatinine ≤ 1.5 times ULN (unless due to lymphoma) OR creatinine clearance (CrCl) ≤ 60 mL/minute * Platelet count ≥ 75,000 mm³ * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2 x ULN

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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

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Medical College of Cornell University

    New York, New York, 10065, United States

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