NCT01400685

Brief Summary

Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias. In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

April 11, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

5 years

First QC Date

April 11, 2011

Last Update Submit

January 23, 2018

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaB Chronic Lymphocytic Leukemia

Keywords

CLLLeukemiaUntreatedB-CLLSLL

Outcome Measures

Primary Outcomes (1)

  • Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL

    2 years

Secondary Outcomes (2)

  • Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL

    2 year

  • Clinical efficacy

    2 years

Interventions

LenalidomideDRUG

Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.

Also known as: CC-5013, Revlimid
BendamustineDRUG

90 mg/m\^2 IV days 1-2 of each cycle for 6 cycles

Also known as: Treanda, SDX 105
RituximabDRUG

375 mg/m\^2 IV day 1 (cycle 1), 500 mg/m\^2 day 1 (cycles 2-6)

Also known as: Rituxan, Mabthera

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia)
  • Life expectancy \> 3 months
  • Organ and marrow function with protocol parameters
  • Able to take aspirin daily

You may not qualify if:

  • Age \>80 years
  • Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
  • Pregnant or breast-feeding
  • Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent
  • Known hypersensitivity to thalidomide or lenalidomide
  • Prior use of lenalidomide
  • Concurrent use of other anti-cancer agents or treatments
  • HIV positive
  • Prior history of another malignancy unless disease free for at least 2 years
  • Uncontrolled intercurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, B-CellLeukemia

Interventions

LenalidomideBendamustine HydrochlorideRituximab

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingButyratesAcids, AcyclicNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jeremy Abramson, M.D.

    Massachusetts General Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
Director, Lymphoma Program

Study Record Dates

First Submitted

April 11, 2011

First Posted

July 22, 2011

Study Start

December 1, 2012

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(2)