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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II, Multi-center, Open-label, Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Low-dose Dexamethasone in Patients With Refractory B Cell Lineage Acute Lymphoblastic Leukemia or in Rela

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).

Detailed Summary: The study consists of two periods, an initial treatment period and an extended treatment period. Patients who meet all eligibility criteria will receive: 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. The daily dose of Lenalidomide and that of Dexamethasone will remain fixed. No dose adaptations are allowed according to the hematologic toxicity. However, in case of non-hematologic grade > 2 toxicity, the next cycle may be delayed up to 21 days after the onset of the event until the adverse event has returned to baseline or ≤ grade 1. Patients may be allowed to receive a pre-treatment with high doses of dexamethasone for initial hyperleukocytosis at the discretion of the investigator. The use of hematopoietic growth factor (HGF) during the initial or extended treatment period is also let at the discretion of the investigator. At the end of the initial treatment period, all responding patients (without HLA compatible donor) or patients showing sufficient clinical activity will be allowed to receive extended treatment with cycles identical to the first cycle. Patients may continue to receive treatment as long as the patient is tolerating the treatment well and the patient's physician believes the patient is receiving some benefit. The severity of adverse events will be graded according to the World Health Organization (WHO) criteria. Any life-threatening adverse effects that are observed during the initial or extended treatment period, which are possibly or probably related to study drug, will require the subject to discontinue study treatment.
Sponsor: Institut de Cancérologie de la Loire

Current Primary Outcome: Disease-Free survival (DFS) [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to response [ Time Frame: 28 days ]
  • Duration of response [ Time Frame: 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) [ Time Frame: All 28 days ]
  • Progression-free survival [ Time Frame: 2 years ]
  • Feasibility of stem cell transplantation (SCT), in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy [ Time Frame: all 28 days ]
  • Safety of lenalidomide plus dexamethasone: adverse events (type, frequency, severity of adverse events, and relationship of adverse events to study drug). [ Time Frame: All 28 days ]
  • To assess the efficacy of lenalidomide plus low-dose dexamethasone: complete response (CR), complete response without platelets (CRp), partial response (PR), and overall response (CR + CRp + PR). [ Time Frame: 1, 8, 15, and 22 of each 28-day cycle (4-weeks cycles) and after treatment, patients will be seen at least twice weekly until they attain a CR ]
  • Overall survival [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Institut de Cancérologie de la Loire

Dates:
Date Received: April 26, 2010
Date Started: January 2010
Date Completion: July 2013
Last Updated: January 14, 2011
Last Verified: January 2011