Open-Label Study of Lenalidomide in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia

NCT01133743 | Completed Phase 2 DMC

• 1 other identifier: RV-CLL-PI-0411
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, non-randomized, single institution study in symptomatic, previously untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle of 28 days duration. Primary endpoint is response.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Lenalidomide; Dexamethasone; Immunomodulatory Drugs(IMiD™); Thalidomide analogues

Outcome Measures

Primary Outcomes (1)

• Response rate

  18 cycles (each cycle is of 28 days)

Secondary Outcomes (1)

• Time to progression

  Participants will be followed until death

Study Arms (1)

Lenalidomide and Dexamethasone

EXPERIMENTAL

Lenalidomide target dose of 25 mg PO OD continuously (28-day cycle) using an initial dose escalation period. Oral dexamethasone 12 mg daily on days 1-7, 14 and 21 of each cycle.

Drug: Lenalidomide and Dexamethasone

Interventions

Lenalidomide and Dexamethasone DRUG

Starting Lenalidomide dose 2.5 mgs or 5 mgs (based on baseline calculated creatinine clearance)PO daily on a 28 day cycle. Dose escalations will take place at the start of subsequent cycles as frequently as tolerated but not more frequently than at the start of each cycle to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle

Also known as: Lenalidomide, Immunomodulatory drug(IMiD™), Thalidomide analogues

Lenalidomide and Dexamethasone

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 IWCLL 2008 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 as per the IWCLL 2008 criteria. One or more of the following must be present to be eligible:
• Massive (\>10cm diameter), progressive or symptomatic lymphadenopathy
• Massive (\>6 cm below costal margin) or progressive or symptomatic splenomegaly
• Anemia (Hb \<110 g/L)
• Thrombocytopenia (platelets \<100 x 109/L)
• Constitutional symptoms (one of the following):
• Weight loss \>10% or more over previous 6 months
• Significant fatigue

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 breast feeding 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.
• Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
• 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.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type B or C.
• Known intolerance to steroids (i.e. poorly controllable hyperglycemia or hypertension, significant mood disturbances, steroid-related myopathy, etc.)

Sponsors & Collaborators

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

Study Sites (1)

University Health Network - Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Chen CI, Paul H, Snitzler S, Kakar S, Le LW, Wei EN, Lau A, Johnston JB, Gibson SB, Queau M, Spaner D, Croucher D, Sherry B, Trudel S. A phase 2 study of lenalidomide and dexamethasone in previously untreated patients with chronic lymphocytic leukemia (CLL). Leuk Lymphoma. 2019 Apr;60(4):980-989. doi: 10.1080/10428194.2018.1508669. Epub 2018 Oct 2.

  PMID: 30277089 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide; Dexamethasone

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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dr. Christine I Chen, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

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: May 19, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

CA (1)