Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)

NCT00751296 | Terminated Phase 2 Results DMC

• 2 other identifiers: Rev-06-0099RV-CLL-PI-0099
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the

• efficacy (response rate) of oral lenalidomide in the treatment of patients with symptomatic, previously untreated, chronic lymphocytic leukemia (CLL),
• toxicity of lenalidomide in patients with CLL as well as time to progression, stable disease duration and, if responses are observed, response duration.

Conditions

Chronic Lymphocytic Leukaemia

Keywords

Lenalidomide; immunomodulatory drug (IMiD®); Thalidomide analogues

Outcome Measures

Primary Outcomes (1)

• To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)

  The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines. Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with \<30% lymphocytes. Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets \> 100 x109/L or 50% improvement over baseline, hemoglobin \> 110 g/L or 50% improvement over baseline (without transfusion).

  Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.

Secondary Outcomes (1)

• Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).

  Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.

Study Arms (1)

Lenalidiomide

EXPERIMENTAL

Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle.Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Also known as: REVLIMID®

Lenalidiomide

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age ≥18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• A confirmed diagnosis of B-cell CLL by NCI Working Group criteria
• No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias (anemia or thrombocytopenia) is NOT considered a prior systemic therapy.
• Radiation: Patients may have received prior radiation therapy restricted to ≤ 25% of functioning bone marrow. Patients must be ≥ 4 weeks since last treatment with radiation therapy.
• Surgery: previous surgery is permissible. Patient must be ≥ 4 weeks since any major surgery.
• Patients must have symptomatic disease requiring therapy. One or more of the following must be present to be eligible:
• Symptomatic lymphadenopathy
• Hepatomegaly and/or splenomegaly
• Anemia (Hb \<110 g/L)
• Thrombocytopenia (platelets \<100)
• Fatigue, weight loss, night sweats, fever (without infection) or other constitutional symptoms felt to require treatment as per treating physician discretion
• Persistent rise in lymphocyte count with doubling time of \< 12 months
• ECOG performance status of ≤ 2 at study entry.

You may not qualify if:

• Patients who fulfill any of the following criteria are not eligible for admission to the study:
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or lactating females. (Lactating females must agree not to breast feed while taking lenalidomide).
• 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.
• Patients previously or currently receiving treatment with other anti-cancer therapy for CLL
• Lymphoproliferative disease other than CLL (includes patients with prolymphocytic leukemia, mantle cell lymphoma, and those who have transformed to a more aggressive lymphoma, or Richter's syndrome).
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type A, B or C.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Celgene: collaborator

Study Sites (1)

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

• Single-Agent Lenalidomide in the Treatment of Previously Untreated Chronic Lymphocytic Leukemia: JCO March 20, 2011 vol. 29 no. 9 1175-1181.
• 'Long-term follow-up of a phase 2 trial of single agent lenalidomide in previously untreated patients with chronic lymphocytic leukaemia,' British Journal of Haematology, 2014, 165, 722-740

MeSH Terms

Conditions

Leukemia, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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

Limitations and Caveats

Original study protocol used a starting lenalidomide dose of 10mg OD for 21days of a 28-day cycle, escalating weekly by 5mg to a target of 25mg daily. Toxicities reported with the first two enrolled patients lead to the current protocol amendment.

Results Point of Contact

• Title: Dr. Christine Chen
• Organization: University Health Network - Princess Margaret Cancer Centre

Christine.Chen@uhn.ca

416-946-2827

Study Officials

• Christine I Chen, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: 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 10, 2008
• First Posted: September 11, 2008
• Study Start: August 1, 2006
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 16, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-05

Locations

CA (1)