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NCT00436618 · REGISTRY CONDITION SEARCH

Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-10-22

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Time to Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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 intent
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    intervention Names
    1. Drug: Everolimus
    label
    Relapsed aggressive non-Hodgkin lymphoma
    type
    EXPERIMENTAL
  2. description
    Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    intervention Names
    1. Drug: Everolimus
    label
    Relapsed indolent non-Hodgkin lymphoma
    type
    EXPERIMENTAL
  3. description
    Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    intervention Names
    1. Drug: Everolimus
    label
    Uncommon lymphomas
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Relapsed aggressive non-Hodgkin lymphoma
    2. Relapsed indolent non-Hodgkin lymphoma
    3. Uncommon lymphomas
    description
    Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    name
    Everolimus
    other Names
    1. Mayo abbreviation: RAD001
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
277
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
    measure
    Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.
    time Frame
    5 years
secondary Outcomes
  1. description
    The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.
    measure
    Overall Survival
    time Frame
    5 years
  2. description
    Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.
    measure
    Progression-free Survival
    time Frame
    5 years
  3. description
    The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.
    measure
    Time to Progression
    time Frame
    5 years
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin lymphoma (closed to accrual as of 8/18/08), aggressive non-Hodgkin's lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of 9/2/08), including Hodgkin's lymphoma, treated with everolimus. Secondary * Evaluate overall survival, progression-free survival, and time to disease progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive lymphoma \[closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma\] vs indolent lymphoma \[closed to accrual as of 8/18/08\] vs uncommon lymphoma \[closed to accrual as of 9/2/08\]). Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies. Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma. After completion of study treatment, patients are followed periodically for up to 5 years.
Source references
references
  1. citation
    Ghobrial 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
    type
    RESULT
  2. citation
    Johnston 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
    type
    RESULT
  3. citation
    Witzig 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
    type
    RESULT
  4. citation
    Zent 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
    type
    RESULT
  5. citation
    Witzig 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
    type
    DERIVED
Source notices and limitations
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