Phase 3
Completed N=450
Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
Source: ClinicalTrials.gov NCT00910910 ↗Enrolled (actual)
450
Serious AEs
53.2%
Results posted
Dec 2016
Primary outcomePrimary: Kaplan-Meier Estimate of Progression Free Survival (PFS) — 30.8; 23.0 months — p=0.323
Summary
The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of Progression Free Survival (PFS) |
30.8; 23.0 | 0.323 |
| PRIMARY Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014 |
30.8; 21.4 | 0.967 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
202; 186; 183; 139; 173; 117 | — |
| SECONDARY Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014 |
216; 202; 194; 155; 188; 131 | — |
| SECONDARY Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines |
51.9; 62.3 | 0.032 sig |
| SECONDARY Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014 |
60.9; 70.2 | 0.047 sig |
| SECONDARY Kaplan-Meier Estimate for Duration of Response |
NA; 105.3 | 0.826 |
| SECONDARY Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014 |
NA; 87.1 | 0.149 |
| SECONDARY Time to Response |
8.6; 8.1 | — |
| SECONDARY Time to Response for a Later Cut-off Date of 31 March 2014 |
10.4; 8.1 | — |
| SECONDARY Kaplan Meier Estimate of Overall Survival |
NA; 44.0 | 0.883 |
| SECONDARY Kaplan Meier Estimate for Overall Survival at the Final Analysis |
74.3; 70.5 | 0.709 |
| SECONDARY Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument |
— | — |
| SECONDARY Euro Quality of Life Five Dimension (EQ-5D) Questionnaire |
— | — |
| SECONDARY Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment |
125; 120; 107; 106; 93; 86 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign an informed consent form.
- Age ≥ 65 years
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of B-cell CLL.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
- Must agree to follow pregnancy precautions as required by the protocol.
- Must agree to receive counseling related to teratogenic and other risks of lenalidomide.
- Must agree not to donate blood or semen as defined by the protocol
Exclusion Criteria
- Prior treatment for B-cell CLL.
- Any medical condition, that would prevent the subject from signing the informed consent form.
- Active infections requiring systemic antibiotics.
- Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
- Pregnant or lactating females.
- Participation in any clinical study or having taken any investigational therapy within 28 days.
- Known presence of alcohol and/or drug abuse.
- Central nervous system (CNS) involvement.
- Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- History of renal failure requiring dialysis.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
- Prior therapy with lenalidomide.
- Evidence of TLS at screening
- Presence of specific hematology and/or chemistry abnormalities
- Uncontrolled hyperthyroidism or hypothyroidism
- Venous thromboembolism within one year
- ≥ Grade-2 neuropathy
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
Data sourced from ClinicalTrials.gov (NCT00910910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.