Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease

NCT00632359 | Completed Phase 2 Results DMC

• 2 other identifiers: 2007-0213NCI-2012-01690
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Lenalidomide; Revlimid

Outcome Measures

Primary Outcomes (3)

• Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation

  To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start \& end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood \&/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: \>50% increase in sum of products of =/\>2 lymph nodes on 2 consecutive examinations; One+ node must be \>2 cm or appearance of new enlarged lymph nodes; \>50% increase in liver \&/or spleen as determined by physical examination/appearance of splenomegaly not previously present; \>50% increase in circulating lymphocytes with absolute count \>10,000.

  Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide Consolidation

• Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria

  Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD.

  12 Months, Disease status assessed at the End of Lenalidomide Consolidation

• Time to Progression

  Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: \>50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. \>50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. \>50% increase in number of circulating lymphocytes with absolute count of at least 10,000.

  From baseline to 12 months

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide 10 mg daily given for 12 months.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

10 mg daily given for 12 months

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should have completed their chemotherapy 3 months prior to start of treatment with lenalidomide and not more than 9 months prior to treatment initiation.
• Patients with CLL/Small Lymphocytic Lymphoma (SLL) that achieve a complete or stable partial remission after combination of chemotherapy. Patients in complete remission need to have documentation of residual disease by immunophenotyping and/or PCR molecular testing.
• Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) status of 0-2.
• Adequate renal and hepatic function (creatinine equal to or less than 2mg/dL - total bilirubin equal to or less than 2).
• Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive months (has NOT had menses at any time in the preceding 24 consecutive months).
• FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control; one highly effective and one additional effective method AT THE SAME TIME at least 28 days before starting taking lenalidomide.
• FCBP must also agree to ongoing pregnancy testing weekly for the first four weeks and then every 28 days while on therapy and at discontinuation of treatment.
• Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
• Age 18 and older.
• Signed, written IRB-approved informed consent.

You may not qualify if:

• Known sensitivity to lenalidomide or thalidomide or it's derivatives
• Known positivity for HIV or active hepatitis B or C.
• Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
• History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Concurrent use of other anti-cancer agents or treatments

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Alessandra Ferrajoli, Professor, Leukemia
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Alessandra Ferrajoli, M.D,

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Locations

US (1)