Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)

NCT00267059 | Completed Phase 2 Results

• 1 other identifier: 2005-0175
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to control CLL in patients who have already received standard therapy. The safety of lenalidomide will also be studied.

Conditions

Chronic Lymphocytic Leukemia; Leukemia

Keywords

Chronic Lymphocytic Leukemia; Lenalidomide; Revlimid; CLL

Outcome Measures

Primary Outcomes (1)

• Number of Patients in Overall Response Categories

  Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.

  Evaluated after three 28-day cycles of lenalidomide.

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

10 mg/day, orally once a day for 28 days

Also known as: CC-5013, 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 with B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group Criteria, or Rai Stage III or IV or patients with CLL requiring treatment because of any of the following: disease related symptoms, progressive marrow failure (development or worsening of anemia and/or patients' thrombocytopenia) progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis
• Patients who have received a minimum of one prior purine analog-based chemotherapy regimen. Prior treatment with corticosteroids, immunotherapy, monoclonal antibody or radiation therapy is permitted. All previous cancer therapy, including radiation, hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in this study. Any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment in this study.
• Age more or equal to 18 years (CLL is not observed in patients less than 18 years of age).
• Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2.
• Adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to 2 times the upper limit of normal.
• Understand and sign Informed Consent after the investigational nature, study design, risks and benefits of the study have been explained.
• Females of childbearing potential (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 method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
• Continued from #7. Men must agree to use a condom during sexual contact with a female of child bearing potential 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.
• Continued from #8. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.

You may not qualify if:

• Known sensitivity to thalidomide or its derivatives
• The development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
• Prior use of lenalidomide
• Concurrent use of other chemotherapy agents.
• Known positivity for Human immunodeficiency virus (HIV) or infectious hepatitis type A, B or C.
• Pregnant or lactating females.
• A serious medical condition, laboratory abnormality or psychiatric illness that would pose the subject at unacceptable risk if he/she were to participate in the study or that would interfere with the ability of the patient to carry out the treatment program or confine the ability to interpret the data from the study.
• Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
• Active cardiovascular disease as defined by the New York Heart Association class 3 or 4.

Sponsors & Collaborators

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

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Takahashi K, Hu B, Wang F, Yan Y, Kim E, Vitale C, Patel KP, Strati P, Gumbs C, Little L, Tippen S, Song X, Zhang J, Jain N, Thompson P, Garcia-Manero G, Kantarjian H, Estrov Z, Do KA, Keating M, Burger JA, Wierda WG, Futreal PA, Ferrajoli A. Clinical implications of cancer gene mutations in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2018 Apr 19;131(16):1820-1832. doi: 10.1182/blood-2017-11-817296. Epub 2018 Jan 22.

  PMID: 29358183 DERIVED

• Ferrajoli A, Lee BN, Schlette EJ, O'Brien SM, Gao H, Wen S, Wierda WG, Estrov Z, Faderl S, Cohen EN, Li C, Reuben JM, Keating MJ. Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia. Blood. 2008 Jun 1;111(11):5291-7. doi: 10.1182/blood-2007-12-130120. Epub 2008 Mar 11.

  PMID: 18334676 DERIVED

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; 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, MD, BS / Associate Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-792-2063

Study Officials

• Alessandra Ferrajoli, MD

  UT M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 20, 2005
• Study Start: December 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 7, 2012
• Results First Posted: April 21, 2011

Record last verified: 2012-08

Locations

US (1)