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Phase 2 N=110 Treatment

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

AIDS-Related Hodgkin Lymphoma · Recurrent Adult Hodgkin Lymphoma · Recurrent Follicular Lymphoma · Recurrent Lymphoplasmacytic Lymphoma · Recurrent Marginal Zone Lymphoma

Enrolled (actual)
110
Serious AEs
54.6%
Results posted
Oct 2019
Primary outcome: Primary: Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only — 1; 0; 3; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Lenalidomide (Drug); Temsirolimus (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only
1; 0; 3; 0; 0; 0
PRIMARY
Complete Response (Phase II)
0; 0; 0; 5; 5; 7
PRIMARY
Overall Response Rate (Phase II)
0; 0; 0; 10; 7; 25 >0.10
SECONDARY
Progression-free Survival (PFS) (Phase II)
7.0; 27.7; 7.0
SECONDARY
Overall Survival (OS) (Phase II)
9.1; 35.8; 25.5

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.

Eligibility Criteria

Inclusion Criteria

  • 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 = = 1,000/uL
  • Platelet count >= 75,000/uL
  • Total bilirubin = = 60 mL/min as determined by calculated Cockcroft-Gault equation
  • Fasting serum cholesterol = 1 cm is acceptable; lesions that are considered non-measurable include the following:
  • Bone lesions (lesions if present should be noted)
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Bone marrow (involvement by lymphoma should be noted)
  • For Waldenstrom's macroglobulinemia, measurable disease is defined as at least one lesion with a single diameter of greater than 2 cm by computed tomography or bone marrow involvement with greater than 10% malignant cells and quantitative monoclonal protein (immunoglobulin M [IgM], IgG, IgA) greater than 1,000 mg/dL
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients who are human immunodeficiency virus (HIV) positive are allowed to participate BUT must meet the following criteria:
  • No acquired immune deficiency syndrome (AIDS)-defining illness, AND
  • Cluster of differentiation (CD) 4 count >= 400 cells/mm^3, AND
  • No anti-retroviral therapy (including high-active antiretroviral therapy [HAART]) within 7 days of starting protocol therapy, AND
  • Patient may not take concurrent anti-retroviral therapy (including HAART) while on protocol
  • NOTE: it is not generally recommended to suspend anti-retroviral therapy (including HAART); the medical team enrolling a patient who suspends anti-retroviral therapy for the purpose of study participation must have a documented note reviewing the potential risks/benefits with the patient in the medical chart

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01076543). 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.

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