Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-06 @ 7:02 PM
Study NCT ID:
NCT00478959
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2007-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
Detailed Description:
While the results of primary therapy for Hodgkin's lymphoma are generally excellent, between 10-20% of patients with advanced stage disease will not enter a complete remission (CR) and between 20-30% of patients will relapse after completion of treatment. Salvage chemotherapy followed by high dose chemotherapy and autologous stem cell transplantation (ASCT) has become the treatment of choice in patients with relapsed or initially chemotherapy-refractory disease.
Although high dose chemotherapy remains a curative option for the treatment of relapsed or chemotherapy-refractory Hodgkin's lymphoma, up to 50% of patients will ultimately recur post-stem cell transplant and will require further treatment.
Thalidomide is an agent that has anti-inflammatory, immunomodulatory and anti-angiogenic properties. Thalidomide has been shown to have activity in a number of solid and hematologic malignancies, and has demonstrated effectiveness in the treatment of refractory multiple myeloma. A dose escalation study of single-agent thalidomide has been performed in heavily pre-treated patients in which two Hodgkin's patients were enrolled and did not respond to treatment. Based on the NCI experience with vinblastine, we initiated a phase II trial examining the combination of thalidomide and vinblastine in patients who were being treated palliatively for Hodgkin's lymphoma. In a heavily pre-treated group of patients (70% of cases having relapsed post-ASCT), a response rate of 40% to the combination was noted with median duration of response of over nine months.
Lenalidomide (Revlimid®) is a thalidomide derivative and the first-in-class novel immunomodulatory agent that has more potent activity as well as a more favourable toxicity profile than the parent compound. Based on the alterations demonstrated in various cytokines and angiogenic markers in patients with Hodgkin's lymphoma, we feel that Lenalidomide's immunomodulatory and anti-angiogenic effects make this an ideal drug to study in this lymphoma. This will be the first study to assess Lenalidomide in patients with Hodgkin's lymphoma.This is a single arm, open-label phase II multi-centre study evaluating the single agent activity of Lenalidomide in relapsed or refractory Hodgkin's lymphoma. The primary endpoint is objective response rate (CR + CRu + PR) as determined by International Workshop Criteria.
Initial treatment will consist of lenalidomide 25 mg PO daily given for 21 consecutive days (days 1 - 21), with seven days off on a 28 day cycle.Patients with PR, CR or CRu, may continue on therapy for 2 cycles past best response.Patients with PD at any time or those with evidence of SD after cycle 4 of monotherapy will be eligible to receive treatment with dexamethasone 40 mg PO daily on days 1 - 4 and 15 - 18 of a 28 day cycle while continuing protocol treatment if they continue to meet the criteria of continuation on therapy.
Although high dose chemotherapy remains a curative option for the treatment of relapsed or chemotherapy-refractory Hodgkin's lymphoma, up to 50% of patients will ultimately recur post-stem cell transplant and will require further treatment.
Thalidomide is an agent that has anti-inflammatory, immunomodulatory and anti-angiogenic properties. Thalidomide has been shown to have activity in a number of solid and hematologic malignancies, and has demonstrated effectiveness in the treatment of refractory multiple myeloma. A dose escalation study of single-agent thalidomide has been performed in heavily pre-treated patients in which two Hodgkin's patients were enrolled and did not respond to treatment. Based on the NCI experience with vinblastine, we initiated a phase II trial examining the combination of thalidomide and vinblastine in patients who were being treated palliatively for Hodgkin's lymphoma. In a heavily pre-treated group of patients (70% of cases having relapsed post-ASCT), a response rate of 40% to the combination was noted with median duration of response of over nine months.
Lenalidomide (Revlimid®) is a thalidomide derivative and the first-in-class novel immunomodulatory agent that has more potent activity as well as a more favourable toxicity profile than the parent compound. Based on the alterations demonstrated in various cytokines and angiogenic markers in patients with Hodgkin's lymphoma, we feel that Lenalidomide's immunomodulatory and anti-angiogenic effects make this an ideal drug to study in this lymphoma. This will be the first study to assess Lenalidomide in patients with Hodgkin's lymphoma.This is a single arm, open-label phase II multi-centre study evaluating the single agent activity of Lenalidomide in relapsed or refractory Hodgkin's lymphoma. The primary endpoint is objective response rate (CR + CRu + PR) as determined by International Workshop Criteria.
Initial treatment will consist of lenalidomide 25 mg PO daily given for 21 consecutive days (days 1 - 21), with seven days off on a 28 day cycle.Patients with PR, CR or CRu, may continue on therapy for 2 cycles past best response.Patients with PD at any time or those with evidence of SD after cycle 4 of monotherapy will be eligible to receive treatment with dexamethasone 40 mg PO daily on days 1 - 4 and 15 - 18 of a 28 day cycle while continuing protocol treatment if they continue to meet the criteria of continuation on therapy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: