NCT01011894

Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

Completed Phase 2 Results posted Last updated 18 May 2017

What this trial tests

Phase 2 trial testing lenalidomide in Chronic Lymphocytic Leukemia in 26 participants. Completed in 23 February 2016.

Timeline

6 November 2009

Primary endpoint
23 February 2016

23 February 2016

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	6 November 2009
Primary completion	23 February 2016
Estimated completion	23 February 2016
Sites	1 location across United States

Drugs / interventions tested

• lenalidomide — full drug profile →

Conditions studied

• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
• Leukemia — all drugs for Leukemia →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

65 and older, any sex, with Chronic Lymphocytic Leukemia or Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Best Response Primary · 2 years

The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Complete Response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment), No constitutional symptoms, ANC \>/= 1,500/ul, platelets\> 100,000/ul, Hgb\>11gm/dl (untransfused); Partial Response (PR): \>50% decrease in peripheral blood lymphocyte count from the pre-treatment baseline value, reduction in lymphadenopathy, reduction in si

Stable Disease

Group	Value	95% CI
Participants Receiving Lenalidomide	20

Progressive Disease

Group	Value	95% CI
Participants Receiving Lenalidomide	3

Not Evaluable

Group	Value	95% CI
Participants Receiving Lenalidomide	3

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intermediate or High Risk Chronic Lymphocytic Leukemia

Serious: 11/26 (42%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	Intermediate or High Risk …
Pneumonia	General disorders	—
Fatigue	General disorders	—
Lung infection	Respiratory, thoracic and mediastinal disorders	—
ALT, SGPT	Blood and lymphatic system disorders	—
Creatinine increased	Metabolism and nutrition disorders	—
Dizziness	General disorders	—
Febrile neutropenia	General disorders	—
Headache	General disorders	—
Skin infection	Skin and subcutaneous tissue disorders	—
Platelet count decreased	Blood and lymphatic system disorders	—
Thrombosis/thrombus/embolism	Cardiac disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	Intermediate or High Risk …
Neutrophil count decreased	Investigations	—
Platelet count decreased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
Alanine aminotransferase increased	Investigations	—
Hyperglycemia	Metabolism and nutrition disorders	—
INR increased	Investigations	—
Hypophosphatemia	Metabolism and nutrition disorders	—
Hyperkalemia	Metabolism and nutrition disorders	—
Thromboembolic event	Vascular disorders	—

Most-reported serious reactions: Pneumonia, Fatigue, Lung infection, ALT, SGPT, Creatinine increased, Dizziness, Febrile neutropenia, Headache.

Data from ClinicalTrials.gov NCT01011894 adverse events section.

Sponsor's own description

The purpose of this study is to:

Determine the likelihood that lenalidomide will adequately control the disease for at least one year.

Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions.

In this case it is considered experimental. The lenalidomide being administered in this study is not a commercially marketed product. Although it is expected to be very similar in safety and activity to the commercially marketed drug, it is possible that some differences may exist. Because this is not a commercially marketed drug, lenalidomide can only be administered to patients enrolled in this clinical trial and may only be administered under the direction of physicians who are investigators in this clinical trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.