Phase 2 N=276 Treatment

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

Leukemia · Lymphoma · Lymphoproliferative Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00436618 ↗

Enrolled (actual)

276

Serious AEs

26.8%

Results posted

Jul 2013

Primary outcome: Primary: 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. — 26; 35; 49 percentage of patients in group

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Everolimus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	26; 35; 49	—
SECONDARY Overall Survival	0.66; 2.45; 3.41	—
SECONDARY Progression-free Survival	0.18; 0.60; 0.79	—
SECONDARY Time to Progression	0.18; 0.60; 0.90	—

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.

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 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 radiotherap

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00436618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.