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Everolimus and Bortezomib in Treating Patients With Relapsed or Refractory Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Everolimus and Bortezomib in Treating Patients With Relapsed or Refractory Lymphoma

A Phase 1 Trial of the Combination of Everolimus (RAD001) and Bortezomib (VELCADE) for Relapsed or Refractory Lymphoma

NCT00671112•Brian Hill, MD, PhD

Summary

RATIONALE: Everolimus and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bortezomib in treating patients with relapsed or refractory lymphoma.

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of everolimus (up to 10 mg PO daily) in combination with bortezomib in patients with relapsed/refractory indolent or mantle cell non-Hodgkin's lymphoma (NHL) including cutaneous forms, or relapsed/refractory aggressive NHL ineligible for hematopoetic stem cell transplantation Secondary * Evaluate the toxicity of this combination. * Assess the pharmacokinetics interactions between these agents. * Assess the response rate and 6-month progression-free survival in treated patients. * Obtain preliminary data to assess associations between tumor characteristics and response to treatment. in those subjects who underwent biopsy prior to study treatment. OUTLINE: This is a dose-escalation study. Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive oral everolimus once daily or once every other day on days 1-21 in all courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients will undergo blood sample collection on Cycle 1, Day 11 for pharmacokinetic studies. Baseline tumor expression of mTOR and NFkB -related proteins (i.e., pS6K, pAKT, and cREL) and FOXP3 is assessed by immunohistochemistry.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
•Diagnosed with relapsed or refractory NHL, limited to subtypes listed below. The subject must have histologic information of diagnosis according to review at the Cleveland Clinic Foundation, either at initial diagnosis or at any subsequent relapse. (Biopsy is not required at relapse, but is suggested. Biopsy at outside institution, reviewed at the Cleveland Clinic, is acceptable.)
•* "Relapsed or refractory" refers to patients who have received at least 1 prior treatment regimen for lymphoma (which may include prior autologous stem cell transplantation) and have demonstrated evidence of progressive disease by clinical and/or radiographic characteristics.
•* "Indolent lymphoma" is included, and refers to small lymphocytic lymphoma/B-cell chronic lymphocytic leukemia (SLL/CLL); lymphoplasmacytic lymphoma (with or without Waldenstrom's macroglobulinemia); hairy cell leukemia; follicular lymphoma (FL) of any grade; marginal zone B-cell lymphoma; or mantle cell lymphoma.
•* Transformed lymphoma is included if patients are ineligible for (or refuse) hematopoetic stem cell transplant.
•* In addition, cutaneous B and T cell lymphoma are permitted. Cutaneous T cell lymphoma must be refractory to 1 prior systemic therapy (topical therapy, photopheresis, radiation are not considered systemic therapy). Transformed B and T cell cutaneous lymphoma are also permitted.

Exclusion Criteria

•* Relapsed/refractory nodal, leukemic, and extranodal T cell lymphomas are eligible. Subtypes eligible include anaplastic large cell lymphoma, angioimmunoblastic T cell lymphoma, PTCL-NOS, nasal or disseminated extranodal T/NK lymphoma, enteropathy-associated T cell lymphoma, hepatosplenic gamma/delta T cell lymphoma, subcutaneous panniculitis-like T cell lymphoma, T-prolymphocytic leukemia, Adult T-cell leukemia/lymphoma, large granular lymphocytic leukemia, aggressive NK leukemia.
•* Plasma cell myeloma and Hodgkin lymphoma are excluded.
•Measurable disease by one of the following: radiographic criteria (≥2 cm by computed tomography); lymphoma involving peripheral blood with more than 5000 leukemia cells/mm3, or any degree of bone marrow infiltration on bone marrow biopsy. Skin involvement with or without nodal or bone marrow involvement permitted for cutaneous lymphomas is also permitted. (see section 6.0, Measurement of Effect).
•Eastern Cooperative Group (ECOG) Performance Status of 0-2.
•Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the laboratory. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis. Serum AST or serum ALT levels must be ≤2.5 x ULN, or ≤5 x ULN for patients with liver involvement by lymphoma.
•Must have adequate bone marrow function:
•* Absolute neutrophil count (ANC) ≥1,000/uL
•* Platelet count (Plt) ≥ 75,000/uL
•* Hemoglobin (Hgb) ≥ 9.0 g/dL
•Must have adequate renal function: Creatinine ≤ 1.5 X ULN.
+35 more criteria

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

October 1, 2015

Last Updated

October 28, 2015

Enrollment

ACTUAL participants

Conditions

714leukemiaLymphoma

Interventions

Bortezomib

DRUG

Everolimus

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Everolimus and Bortezomib in Treating Patients With Relapsed or Refractory Lymphoma

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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