New drug combo shows early promise for recurrent lymphoma
NCT ID NCT01644799
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Aug 2013
- Finished
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May 2017
- 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.
* 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
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Ohio State University Medical Center
Columbus, Ohio, 43210, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Weill Medical College of Cornell University
New York, New York, 10065, United States
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