AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT00974233

Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL

A Phase 2 study testing Bendamustine, Rituximab and Lenalidomide in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by University of Wisconsin, Madison at 10 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bendamustine, Rituximab and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
10 sitesUnited States
Study dates
Oct 2009to Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at least one prior chemotherapy regimen.
  • In cases of SLL, patients must have at least one bidimensionally measurable lesion at least ≥1.5 cm measured in one dimension.
  • ECOG performance status of 0-2 at study entry
  • Laboratory test results within these ranges: ANC <=1500/μL, Platelet count <= 100,000/μL. Patients with ANC <1500/μL or plt <100,000/μL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible.
  • creatinine clearance of >60 mL/min as determined by the Cockcroft-Gault calculation.
  • Total bilirubin <= 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
Show all 10Show fewer
  • Serum transaminases AST (SGOT) and ALT (SGPT) <=5x ULN, Serum alkaline phosphatase ≤5 X ULN.
  • Disease free of prior malignancies for ≥ 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery).
  • Patients may have received prior therapy with bendamustine or lenalidomide, but must not have disease that is refractory to bendamustine or lenalidomide.
  • Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.

Who cannot join

  • Has received >5 lines of prior therapy for their disease. Re-treatment with an identical regimen does not count as a new regimen.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or comply with the protocol treatment.
  • Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
  • Prior history or current evidence of central nervous system or leptomeningeal involvement.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Known hypersensitivity to thalidomide.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Known to be positive for HIV or infectious hepatitis, type B or C.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • St Vincent Regional Cancer Center

    Green Bay, Wisconsin, 54301

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54313

  • Mercy Health System Heme/Onc

    Janesville, Wisconsin, 53548

  • Gundersen Clinic

    La Crosse, Wisconsin, 54601

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Riverview Hospital

    Wisconsin Rapids, Wisconsin, 54494

Other trials in United States

About this study

Official title: Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL

The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).

The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

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

What participants receive

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

  • BendamustineDrug

    Also called Treanda

    90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles

  • RituximabDrug

    Also called rituxan

    375 mg/m2 Day 1 every 28 days for 6 cycles

  • LenalidomideDrug

    Also called revlimid, CC-5013

    5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.

Study groups in NCT00974233
Study groupRoleWhat they receive
Induction/Maintenance chemotherapyExperimentalBendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Lenalidomide

What is being measured

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

  1. Progression Free Survival

    The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).

    Measured: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)

  2. Progression-free Survival

    Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.

    Measured: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)

Secondary outcomes (3)

  1. Objective Response Rate (Complete + Partial Responses)

    Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.

    Measured: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)

  2. Toxicities Observed With Induction Chemotherapy and Maintenance Therapy

    Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.

    Measured: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)

  3. Overall Survival

    Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.

    Measured: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)

Timeline

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

  1. First posted10 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJul 2013
  4. Study completionApr 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974233
Sponsor's protocol ID
HO08405
Other IDs
RV-CLL/SLL-PI-397, A534260, SMPH\MEDICINE\HEM-ONC, H-2009-0087, NCI-2011-00646
Status last verified
Jul 2017
First submitted
9 Sep 2009
Last updated
2 Dec 2019
Data monitoring committee
No

Publications

  • Chang JE, Wang T, Kim K, Folstad M, Endres M, Howard M, Kenkre V, Fletcher C, Rajguru S. Maintenance low-dose fixed duration lenalidomide and rituximab following bendamustine and rituximab induction in previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2024 Oct;65(10):1456-1464. doi: 10.1080/10428194.2024.2360535. Epub 2024 Jun 10.

    PubMed 38856101

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Rituximab and Lenalidomide in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by University of Wisconsin, Madison at 10 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 10 inclusion and 8 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)). The study lists 2 primary outcomes in all. 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 NCT00974233, which also lists 1 linked publication.

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 2 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in