NCT02240719

Brief Summary

This phase I trial studies the side effects and the best dose of everolimus when given together with bendamustine hydrochloride in treating patients with cancer of the blood (hematologic cancer) that has returned after a period of improvement (relapsed) or did not get better with a particular treatment (refractory). Everolimus may prevent cancer cells from growing by blocking a protein that is needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with bendamustine hydrochloride may be a better treatment for hematologic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

September 12, 2014

Last Update Submit

January 2, 2019

Conditions

Recurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRefractory Chronic Lymphocytic LeukemiaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • MTD of everolimus, defined as the dose that produces dose-limiting toxicity (DLT) in =< 1/6 patients, determined by incidence of DLT graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI CTCAE version 4.0) and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.

    28 days

Secondary Outcomes (2)

  • Incidence and severity of adverse events as defined by the NCI CTCAE version 4.03

    Up to 30 days post-treatment

  • Response rates (complete response, partial response, stable disease)

    Up to 30 days post-treatment

Study Arms (1)

Everolimus + Bendamustine

EXPERIMENTAL

Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2 and everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: everolimusDrug: bendamustine hydrochloride

Interventions

everolimusDRUG

Given PO

Also known as: 42-O-(2-hydroxy)ethyl rapamycin, Afinitor, RAD001
Everolimus + Bendamustine
bendamustine hydrochlorideDRUG

Given IV

Also known as: bendamustin hydrochloride, bendamustine, cytostasan hydrochloride, Treanda
Everolimus + Bendamustine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Measurable disease
  • Baseline hemoglobin level of \> 7.0 g/dl
  • Understand and voluntarily sign an informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements
  • All the patients need to have biopsy proven active disease at the time of clinical trial
  • Eastern Cooperative Oncology Group performance status of =\< 2 study entry
  • Absolute neutrophil count \>= 1,000/mm\^3
  • Platelet count \>= 50,000/mm\^3
  • Calculated creatinine clearance \> 40 ml/min or 24 hour urine
  • Total bilirubin =\< 2 x upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x upper limit of normal
  • International normalized ratio \< 2

You may not qualify if:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
  • Any severe and/or uncontrolled medical conditions
  • Uncontrolled diabetes mellitus
  • Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
  • Currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of everolimus
  • Known hypersensitivity to everolimus or bendamustine
  • Known central nervous system (CNS) disease (NHL, diffuse large B cell lymphoma \[DLBCL\])
  • Recent major surgery within 14 days prior to cycle 1, day 1
  • Taking strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
  • Received live attenuated vaccines
  • Known sero-positive for active or past viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are sero-positive because of hepatitis B virus vaccine are eligible
  • History of another primary malignancy
  • History of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
  • Pregnant or nursing (lactating) women
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseHodgkin DiseaseLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellMultiple Myeloma

Interventions

EverolimusBendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsButyratesAcids, AcyclicCarboxylic AcidsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mehrdad Abedi

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

October 1, 2014

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

US(1)