Pilot Study to Establish Safety & Efficacy of a Combination of Dexamethasone and Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia (CLL)

NCT01459211 | Completed Phase 2 DMC

• 1 other identifier: UCL/09/387
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to establish the safety and efficacy of a combination of dexamethasone and lenalidomide (Revlimid®) (D+L) in subjects with relapsed or refractory CLL who have failed or are unable to tolerate standard up-front therapy with regimens containing Fludarabine or in those with mutations in the p53 gene, CAMPATH-1H.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve objective response (CR + PR) according to the updated 1996 NCIWG criteria measured at 4 weeks after the completion of chemotherapy

  4 weeks after the completion of chemotherapy

Secondary Outcomes (2)

• Duration of response

  Time from initial response to first relapse/progression or death

• Time to next treatment

  Time from end of chemotherapy to next treatment

Study Arms (1)

Lenalidomide & Dexamethasone

OTHER

Lenalidomide, 5mg daily, increased to 10mg after 1st cycle. Dexamethasone, 20mg days 1-4 each cycle

Drug: Lenalidomide & Dexamethasone

Interventions

Lenalidomide & Dexamethasone DRUG

Subjects with relapsed or refractory CLL will receive twelve 28-day cycles of treatment. Each cycle will consist of: 1. Oral Dexamethasone (20mg daily, days 1-4), 2. Oral Lenalidomide on days 1-28 of each cycle, starting at 5mg per day in cycle 1 in patients with creatinine clearance ≥ 60ml/min calculated by Cockcroft-Gault. The dose will be increased to 10mg per day with cycles 2-12 unless there is evidence of disease progression or unacceptable drug toxicity

Also known as: Revlimid

Lenalidomide & Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Diagnosis of relapsed or refractory CLL as defined by the NCIWG criteria, requiring treatment
• lines of prior therapy
• Fludarabine- or Alemtuzumab-based therapy inappropriate
• WHO Performance status ≤2
• Age ≥ 18 years
• Life expectancy \> 6 months
• Male and female subjects must agree to follow the Lenalidomide Pregnancy Prevention Risk Management Plan (including contraception 4 weeks before, during and 4 weeks after treatment for females of child-bearing potential).
• Signed informed consent

You may not qualify if:

• Previously untreated CLL
• Fit patients for whom alemtuzumab or fludarabine- based therapy would be appropriate
• Creatinine clearance \< 30ml/min calculated by Cockcroft-Gault
• Bilirubin \> 1.5 x upper limit of normal
• Patients with marrow suppression resulting in significant cytopenia (Neutrophils \<0.5 x 109/l, Platelets \<30 x 109/l).
• Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy or other investigational therapy within 4 weeks prior to study Day 1.
• Known infection with HIV, hepatitis B or hepatitis C.
• Uncontrolled glaucoma, diabetes mellitus, hypertension or symptomatic peptic ulcer disease
• Peripheral neuropathy \> grade 1
• Proven or suspected transformation to aggressive B-cell malignancy (e.g. large -B-cell lymphoma, Richter's syndrome, or PLL).
• Second malignancy requiring treatment other than non metastatic skin or prostate tumours
• Any medical condition that would require long-term use (\>1 month) of systemic corticosteroids at a dose greater than 5mg/day of prednisolone during study treatment.
• Active uncontrolled bacterial, viral or fungal infections Cardiac failure, myocardial infarction within 6 months prior to study day 1, or evidence of ischaemia on ECG within 30 days prior to study day 1.
• Epileptic disorders requiring anticonvulsant therapy
• Major surgery, other than diagnostic surgery within 4 weeks prior to Study Day 1.

Sponsors & Collaborators

• University College, London: lead

Study Sites (2)

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

University College London

London, W1T 4TJ, United Kingdom

Location

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

• Amit Nathwani

  University College, London

  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: October 18, 2011
• First Posted: October 25, 2011
• Study Start: May 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

GB (2)