Clinical trial · Interventional
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Phase II Trial of Everolimus (RAD001) in Relapsed/Refractory Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Relapsed aggressive non-Hodgkin lymphoma
- description
- Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- interventionNames
- Drug: Everolimus
- type
- EXPERIMENTAL
- label
- Relapsed indolent non-Hodgkin lymphoma
- description
- Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- interventionNames
- Drug: Everolimus
- type
- EXPERIMENTAL
- label
- Uncommon lymphomas
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Biopsy-proven\* relapsed or refractory lymphoma, including the following:
* Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma)
* Transformed lymphoma
* Diffuse large B-cell lymphoma
* Mantle cell lymphoma
* Grade 3 follicular lymphoma
* Precursor B-cell lymphoblastic leukemia/lymphoma
* Mediastinal (thymic) large B-cell lymphoma
* Burkitt's lymphoma/leukemia
* Precursor T-cell lymphoblastic leukemia/lymphoma
* Primary cutaneous anaplastic large cell lymphoma
* Primary systemic type anaplastic large cell lymphoma
* Indolent lymphoma (closed to accrual as of 8/18/08)
* Small lymphocytic lymphoma/chronic lymphocytic leukemia
* Grade 1 or 2 follicular lymphoma
* Extranodal marginal zone B-cell lymphoma of MALT type
* Nodal marginal zone B-cell lymphoma
* Splenic marginal zone B-cell lymphoma
* Uncommon lymphoma (closed to accrual as of 9/2/08)
* Unspecified peripheral T-cell lymphoma
* Anaplastic large cell lymphoma (T and null cell type)
* Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)
* Central Nervous System (CNS) lymphoma
* Post-transplant lymphoproliferative disorder
* Mycosis fungoides/Sezary syndrome
* Hodgkin's lymphoma
* Primary effusion lymphoma
* Blastic Natural Killer(NK)-cell lymphoma
* Adult T-cell leukemia/lymphoma
* Nasal type extranodal NK/T-cell lymphoma
* Enteropathy type T-cell lymphoma
* Hepatosplenic T-cell lymphoma
* Subcutaneous panniculitis-like T-cell lymphoma
* Angioimmunoblastic T-cell lymphoma
NOTE: \*Biopsies performed \< 6 months prior to study entry are allowed; biopsy-proven CNS lymphoma (at any time) does not require a re-biopsy in order to be eligible for this study
* Previously treated disease
* Patients with aggressive lymphoma (closed to accrual as of 8/24/07) OR Hodgkin's lymphoma must have received or be ineligible for potentially curative therapy, including stem cell transplantation
* Measurable disease\*\* by CT scan or MRI, defined by 1 of the following:
* At least 1 unidimensionally measurable lesion \> 2 cm in diameter
* Skin lesions may be used if they meet this criterion and are photographed with a ruler
* More than 5,000/mm³ tumor cells in the blood
NOTE: \*\*For patients with lymphoplasmacytic lymphoma without measurable lymphadenopathy, measurable disease may be defined by bone marrow lymphoplasmacytosis with \> 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND quantitative Immunoglobulin M(IgM) monoclonal protein \> 1,000 mg/dL
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group(ECOG) performance status 0-2
* Life expectancy \> 3 months
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN
* aspartate aminotransferase(AST) ≤ 3 times ULN (5 times ULN if liver involvement is present)
* Creatinine ≤ 2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide blood samples and portion of bone marrow aspirate and biopsy during study participation
* Able to swallow intact study medication tablets
* No other life-threatening illness (unrelated to tumor)
* No serious non-malignant disease (e.g., active infection or other condition) that, in the opinion of the investigator, would preclude study participation
* No other active malignancy requiring treatment or that would preclude study participation
* No known HIV positivity
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior myelosuppressive chemotherapy or biologic therapy (unless the patient has recovered from the nadir of the previous treatment)
* More than 3 weeks since prior radiotherapy (unless the acute side effects associated with therapy are resolved)
* Concurrent stable (i.e., not increased within the past month) chronic doses of corticosteroids, with a maximum dose of 20 mg of prednisone per day, is allowed if prescribed for disorders other than lymphoma (e.g., rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma)
* Non-escalating doses of steroids at the lowest possible dosing level are allowed for CNS lymphoma
* No other concurrent investigational ancillary therapy
* No other concurrent chemotherapy, immunotherapy, or radiotherapy
* No concurrent participation in any other clinical trial involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intentReferences
Publications (5)
- RESULTGhobrial IM, Gertz M, Laplant B, Camoriano J, Hayman S, Lacy M, Chuma S, Harris B, Leduc R, Rourke M, Ansell SM, Deangelo D, Dispenzieri A, Bergsagel L, Reeder C, Anderson KC, Richardson PG, Treon SP, Witzig TE. Phase II trial of the oral mammalian target of rapamycin inhibitor everolimus in relapsed or refractory Waldenstrom macroglobulinemia. J Clin Oncol. 2010 Mar 10;28(8):1408-14. doi: 10.1200/JCO.2009.24.0994. Epub 2010 Feb 8. PMID 20142598
- RESULTJohnston PB, Inwards DJ, Colgan JP, Laplant BR, Kabat BF, Habermann TM, Micallef IN, Porrata LF, Ansell SM, Reeder CB, Roy V, Witzig TE. A Phase II trial of the oral mTOR inhibitor everolimus in relapsed Hodgkin lymphoma. Am J Hematol. 2010 May;85(5):320-4. doi: 10.1002/ajh.21664. PMID 20229590
- RESULTWitzig TE, Reeder CB, LaPlant BR, Gupta M, Johnston PB, Micallef IN, Porrata LF, Ansell SM, Colgan JP, Jacobsen ED, Ghobrial IM, Habermann TM. A phase II trial of the oral mTOR inhibitor everolimus in relapsed aggressive lymphoma. Leukemia. 2011 Feb;25(2):341-7. doi: 10.1038/leu.2010.226. Epub 2010 Dec 7. PMID 21135857
- RESULTZent CS, LaPlant BR, Johnston PB, Call TG, Habermann TM, Micallef IN, Witzig TE. The treatment of recurrent/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) with everolimus results in clinical responses and mobilization of CLL cells into the circulation. Cancer. 2010 May 1;116(9):2201-7. doi: 10.1002/cncr.25005. PMID 20166206
- DERIVEDWitzig TE, Reeder C, Han JJ, LaPlant B, Stenson M, Tun HW, Macon W, Ansell SM, Habermann TM, Inwards DJ, Micallef IN, Johnston PB, Porrata LF, Colgan JP, Markovic S, Nowakowski GS, Gupta M. The mTORC1 inhibitor everolimus has antitumor activity in vitro and produces tumor responses in patients with relapsed T-cell lymphoma. Blood. 2015 Jul 16;126(3):328-35. doi: 10.1182/blood-2015-02-629543. Epub 2015 Apr 28. PMID 25921059