Lenalidomide Plus Bendamustine and Rituximab for Untreate... | NCT01400685

Studies
Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

NCT01400685

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jan 25, 2018Actual

Enrollment

34Estimated

Phase

Phase 1

Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
B Chronic Lymphocytic Leukemia

Interventions

Lenalidomide
Bendamustine
Rituximab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Apr 11, 2011

First Submission Date that Met QC Criteria

Jul 21, 2011

First Posted Date

Jul 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4 weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on day 1 of each cycle.

Subjects will receive routine blood tests and physical exam during each cycle. Tumor assessments by CT scan will be performed during cycles 2, 4, and 6.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Other Names
Lenalidomide	Drug	Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.	CC-5013 Revlimid
Bendamustine	Drug	90 mg/m^2 IV days 1-2 of each cycle for 6 cycles	Treanda SDX 105
Rituximab	Drug	375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)	Rituxan Mabthera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL		2 years

Secondary Outcomes

Measure	Description	Time Frame
Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL		2 year
Clinical efficacy	response rate, progression-free and overall survival	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy Abramson, M.D.	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02214	United States
Dana-Farber Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D015448	Leukemia, B-Cell
D007938	Leukemia

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077269	Lenalidomide
D000069461	Bendamustine Hydrochloride
D000069283	Rituximab

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided