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Chronic Lymphocytic LeukemiaPhase 1NCT01400685

Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

A Phase 1 study testing Lenalidomide, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lenalidomide, Bendamustine and Rituximab
Type of treatment
Injection or infusion
How many people
34 participants
Where
2 sitesUnited States
Study dates
Dec 2012to Jan 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study

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.

Read the 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.

Keywords
CLL, Leukemia, Untreated, B-CLL, SLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called CC-5013, Revlimid

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

  • BendamustineDrug

    Also called Treanda, SDX 105

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

  • RituximabDrug

    Also called Rituxan, Mabthera

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (2)

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

    Measured: 2 year

  2. Clinical efficacy

    response rate, progression-free and overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2011 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01400685
Sponsor's protocol ID
11-016
Status last verified
Jan 2018
First submitted
11 Apr 2011
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01400685.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.

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