Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older

NCT00535873 | Completed Phase 2 Results DMC

• 1 other identifier: 2006-0715
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older. Secondary Objective:
• To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older

Conditions

Leukemia; CLL; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Keywords

Leukemia; CLL; chronic lymphocytic leukemia; SLL; small lymphocytic lymphoma; Untreated CLL; Lenalidomide; CC-5013; Revlimid; Oral

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes \>1500/µL, platelets \>100,000/µL, hemoglobin \>11.0 g/dL (untransfused); lymphocyte count \<5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \<30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets \>100,000/µL or 50% improvement ; Hemoglobin \>11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.

  From 3 cycles (90 days) up to 6 cycles (approximately 180 days)

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.

Also known as: Revlimid, CC-5013

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Patients with untreated CLL or small lymphocytic lymphoma (SLL) with indication to treatment according to NCI Working Group guidelines.Patients that have received single agent rituximab will be allowed to participate in this study.
• Age 65 or older
• Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 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 upper level of normal and as alanine aminotransferase (ALT) less or equal 2 upper limit of normal (ULN).
• Able to understand and sign Informed Consent after the investigational nature, study design, risks and benefits have been explained.
• Able to adhere to the study visit schedule and other protocol requirements.
• 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.
• 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; 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). 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
• Continued from above. 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.
• 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.
• All patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to Acetylsalicylic Acid (ASA) may use warfarin or low molecular weight heparin.

You may not qualify if:

• Known sensitivity to thalidomide or its derivatives.
• Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
• Known positivity for HIV or active hepatitis (B or C).
• A serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the Principal Investigator.
• Active cardiovascular disease as defined by the New York Heart Association Class 3 or 4.
• History of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Concurrent use of other chemotherapy agents.
• Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
• No known history of tuberculosis or recent exposure to tuberculosis.

Sponsors & Collaborators

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

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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

• Strati P, Keating MJ, Wierda WG, Badoux XC, Calin S, Reuben JM, O'Brien S, Kornblau SM, Kantarjian HM, Gao H, Ferrajoli A. Lenalidomide induces long-lasting responses in elderly patients with chronic lymphocytic leukemia. Blood. 2013 Aug 1;122(5):734-7. doi: 10.1182/blood-2013-04-495341. Epub 2013 Jun 25.

  PMID: 23801633 DERIVED

• Badoux XC, Keating MJ, Wen S, Lee BN, Sivina M, Reuben J, Wierda WG, O'Brien SM, Faderl S, Kornblau SM, Burger JA, Ferrajoli A. Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood. 2011 Sep 29;118(13):3489-98. doi: 10.1182/blood-2011-03-339077. Epub 2011 Jul 1.

  PMID: 21725050 DERIVED

Related Links

• M.D. Anderson Cancer Center's website

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; 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/Associate Professor
• Organization: The University of Texas M D Anderson Cancer Center

eharriso@mdanderson.org

713-792-2063

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: September 25, 2007
• First Posted: September 26, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 21, 2018
• Results First Posted: September 2, 2013

Record last verified: 2018-07

Locations

US (1)