Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)

NCT01403246 | Terminated Phase 1 Results

• 1 other identifier: CLL0709
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 10

Brief Summary

This is a phase I multicenter, open label study in previously untreated and elderly patients (\> 60 years) with CLL: a non-comparative phase aimed at defining the MTD of lenalidomide given in combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL; Lenalidomide; Chlorambucil; No previous treatment

Outcome Measures

Primary Outcomes (1)

• Number of Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil.

  At maximum 8 months from induction therapy start

Study Arms (1)

Lenalidomide with Chlorambucil

EXPERIMENTAL

Drug: Lenalidomide; Chlorambucil

Interventions

Lenalidomide; Chlorambucil DRUG

MTD of lenalidomide given in combination with chlorambucil

Lenalidomide with Chlorambucil

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CLL diagnosis according to the 2008 revised NCI criteria.
• Age \> 65 years or between 60 and 65 years if not suitable for fludarabine-based regimens according to the investigator's judgment.
• ECOG performance status of ≤2 at study entry.
• No previous treatment.
• Advanced stage or progressive CLL according to the 2008 revised NCI criteria.
• Disease-free of prior malignancies other than CLL for ≥3 years, with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
• Able to take low molecular weight heparin or in alternative, low-fixed-dose warfarin or, in alternative, low-dose aspirin.
• Able to adhere to the study visit schedule and other protocol requirements.
• Female subjects of childbearing potential(FCBP) must:
• Understands the potential teratogenic risk to the unborn child and the need for effective contraception;
• Be capable of complying with effective contraceptive measures.
• Be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy.
• Understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test.
• Uderstand the need and accepts to undergo pregnancy testing based on the frequency outlined in this protocol.
• Contraception.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• A CIRS score \> 6.
• Pregnant or Lactating Females.
• Known positive serology for HIV or active hepatitis B or C.
• Active infection requiring systemic anti-viral, antibiotic or anti-fungal therapy.
• History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
• History of renal failure requiring dialysis.
• Known presence of alcohol and/or drug abuse.
• History of thrombosis, thromboembolism within one year.
• Hearth failure, arrhythmia.
• ≥ grade 2 neuropathy.
• Uncontrolled hyperthyroidism or hypothyroidism.
• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
• One or more laboratory abnormalities:
• calculated creatinine clearance (Cockroft-Gault) \<60mL/min;

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (10)

Azienda Spedali Civili

Brescia, 25100, Italy

Location

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

Catania, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, 88100, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

Catanzaro, Italy

Location

Clinica Ematologica - Università degli Studi

Genova, Italy

Location

UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

Milan, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Italy

Location

Umberto I di Roma - Dipartimento di Biotecnologie Cellulari ed Ematologia

Roma, 00161, Italy

Location

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni

Terni, Italy

Location

Related Links

• GIMEMA Foundation Webpage

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide; Chlorambucil

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; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Alfonso Piciocchi
• Organization: GIMEMA

a.piciocchi@gimema.it

+393203671224

Study Officials

• Roberto Foà

  Umberto I - Dipartimento di Biotecnologie Cellulari ed Ematologia Cellulari

  PRINCIPAL INVESTIGATOR

• Francesca Romana Mauro, Co-Coordinator

  Umberto I - Dipartimento di Biotecnologie Cellulari ed Ematologia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: July 27, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 12, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Locations

IT (10)