Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Dexamethasone in Patients With Lymphoblastic Leukemia

NCT01116193 | Completed Phase 2 DMC

• 2 other identifiers: 2009-01b2009-009372-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

The study objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).

Conditions

Leukemia, Lymphoid; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Keywords

antileukemic therapy; lymphoblastic leukemia; lenalidomide; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Disease-Free survival (DFS)

  2 years

Secondary Outcomes (8)

• Time to response

  28 days

• Duration of response

  2 years

• To determine quality of life (QOL): European Organization for Research and Treatment of Cancer QOL questionnaire for patients with cancer (EORTC QLQ-C30)

  All 28 days

• Progression-free survival

  2 years

• Feasibility of stem cell transplantation (SCT), in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy

  all 28 days

Interventions

Lenalidomide plus dexamethasone DRUG

Lenalidomide 25 mg p.o. once daily on days 1-21 plus Dexamethasone 40 mg p.o. once daily on days 1, 8, 15, and 22 of each 28-day cycle (4-weeks cycles) until CR achievement, progression of disease or intolerable toxicity

Also known as: Revlimid ®, 25mg

Eligibility Criteria

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

You may qualify if:

• Documented B-cell lineage acute lymphoblastic leukemia (non-Philadelphia positive chromosome), which under WHO guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma.
• Performance status of ≤ 2 by Eastern Cooperative Oncology Group (ECOG) criteria.
• Any age ≥ 18 years is allowed.
• Life expectancy of at least 3 months.
• Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \> 3 times upper limits of normal).
• Adequate kidney function (calculated creatinine clearance \> 50 ml/min).
• Signed informed consent prior to start of any study-specific procedures.
• The patients refusing the preservation of their biological samples can however participate in the study.
• All subjects must
• Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
• Agree not to share study medication with another person and to return all unused study drug to the investigator
• Female subjects of childbearing potential must :
• Understand that the study medication is expected to have a teratogenic risk
• Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout the entire duration of study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception
• Implant

You may not qualify if:

• Active serious infection not controlled by oral or intravenous antibiotics.
• Treatment with any investigational antileukemic agent or chemotherapy agent in at least 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given.
• Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator.
• Patients with clinical evidence of active central nervous system (CNS) disease.
• Pregnant and/or lactating female.
• Patients with known human immunodeficiency virus (HIV) infection.
• Patients with known active hepatitis B and/or hepatitis C infection.
• Hypersensitive or intolerant to any component of the study drug formulation.

Sponsors & Collaborators

• Institut de Cancérologie de la Loire: lead
• Celgene Corporation: collaborator

Study Sites (4)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Michallon

Grenoble, 38000, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

MeSH Terms

Conditions

Leukemia, Lymphoid; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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

• Emmanuelle Tavernier, MD

  Institut de Cancérologie de la Loire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: May 4, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2013
• Last Updated: September 14, 2017

Record last verified: 2011-01

Locations

FR (4)