Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
Phase I/II Investigation of Temsirolimus Plus Lenalidomide in Relapsed Non-Hodgkin Lymphomas
7 other identifiers
interventional
110
1 country
11
Brief Summary
This phase I/II trial studies the side effects and the best dose of lenalidomide when given together with temsirolimus and to see how well it works in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that has come back after a period of improvement or is not responding to treatment. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of Hodgkin lymphoma or non-Hodgkin lymphoma by blocking blood flow to the cancer. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2010
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedStudy Start
First participant enrolled
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedResults Posted
Study results publicly available
October 16, 2019
CompletedOctober 16, 2019
September 1, 2019
7.7 years
February 25, 2010
August 15, 2019
September 24, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only
Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
28 days
Complete Response (Phase II)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions;
Up to 1 year
Overall Response Rate (Phase II)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 1 year
Secondary Outcomes (2)
Progression-free Survival (PFS) (Phase II)
Time from study entry until disease progression or death from any cause, assessed up to 5 years
Overall Survival (OS) (Phase II)
Time from study entry until death from any cause, assessed up to 6 years
Study Arms (1)
Treatment (lenalidomide, temsirolimus)
EXPERIMENTALPatients receive lenalidomide PO on days 1-21 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses may continue therapy for up to 52 weeks.
Interventions
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Histology: bone marrow biopsies (with the exception of lymphoplasmacytic lymphoma) as the sole means of diagnosis are not acceptable; fine needle aspirates are not acceptable
- Phase I: previously treated, histologically confirmed Hodgkin and non-Hodgkin lymphomas; the only exception to a requirement for a lymph node biopsy is lymphoplasmacytic lymphoma, which can be diagnosed based on morphologic evidence in the bone marrow plus the appropriate paraprotein
- Phase II: previously treated, histologically confirmed mature non-Hodgkin lymphoma (NHL) stratified by histology:
- Group A: diffuse large B-cell lymphoma (NOTE: all patients with DLBCL must have germinal center vs. non-germinal center phenotype established via immunohistochemistry)
- Group B: follicular lymphoma
- Group C: lymphoma NOS (including Hodgkin lymphoma, T-NHL, marginal zone lymphoma, lymphoplasmacytic
- No limit to number of prior therapies; prior autologous transplantation is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Absolute neutrophil count (ANC) \>= 1,000/uL
- Platelet count \>= 75,000/uL
- Total bilirubin =\< 1.5 times upper limit of normal (ULN) (unless due to Gilbert's)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times ULN
- Creatinine clearance \>= 60 mL/min as determined by calculated Cockcroft-Gault equation
- Fasting serum cholesterol =\< 350 mg/dL
- Fasting serum triglycerides =\< 2.5 times ULN
- +15 more criteria
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients who are receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biological composition to temsirolimus or lenalidomide used in study
- Patients requiring active anti-retroviral therapy for HIV are excluded
- No "currently active" second malignancy, other than non-melanoma skin cancers; patients are not considered to have a "currently active" second malignancy if they have completed anti-cancer therapy and are considered by their physicians to be at less than 30% risk of relapse
- No history (within 3 months of study entry) of deep venous thrombosis/pulmonary embolism (DVT/PE); patients with a distant history (greater than 3 months before study entry) of DVT/PE are eligible, but should receive prophylactic aspirin or low molecular weight heparin
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with relapsed/refractory DLBCL or HL who are eligible and willing to undergo potentially curative stem cell transplant
- Patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) are excluded
- No corticosteroids within 14 days prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 10 mg/day prednisone or equivalent; any patient on steroid therapy must receive thromboembolic prophylaxis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Related Publications (1)
Major A, Kline J, Karrison TG, Fishkin PAS, Kimball AS, Petrich AM, Nattam S, Rao K, Sleckman BG, Cohen K, Besien KV, Rapoport AP, Smith SM. Phase I/II clinical trial of temsirolimus and lenalidomide in patients with relapsed and refractory lymphomas. Haematologica. 2022 Jul 1;107(7):1608-1618. doi: 10.3324/haematol.2021.278853.
PMID: 34320785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sonali Smith, Professor of Medicine
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Sonali Smith
University of Chicago Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
April 15, 2010
Primary Completion
December 31, 2017
Study Completion
September 30, 2018
Last Updated
October 16, 2019
Results First Posted
October 16, 2019
Record last verified: 2019-09