Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604028
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2020-09-21
Brief Title:
Lenalidomide and Low-dose Cyclophosphamide for MALT Lymphoma
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase II Trial of Combination of Oral Lenalidomide and Low-dose Cyclophosphamide for Patients With Antibiotics-unresponsive Extranodal Marginal Zone B-cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
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:
LCMALT
Brief Summary:
Considering that lenalidomide and cyclophosphamide are found to have anti-tumor effects in MALT lymphoma the investigators speculated that combined lenalidomide and low-dose cyclophosphamide can increase the overall response rate as well as dural time of tumor remission and avoid alternative treatments including radiotherapy or chemotherapy-related adverse effects in antibiotics-unresponsive relapsed or refractory extranodal MALT lymphoma Therefore in this proposal the investigators will design a prospective phase II study to evaluate the treatment efficacies of combination of oral lenalidomide and low-dose cyclophosphamide LC lenalidomide Leavdo 15 mg daily day 1 to day 21 cyclophosphamide Endoxan 50 mg daily day 1 to day 21 courses will be repeated every 28 days in patients with antibiotics-unresponsive relapsed or refractory extranodal MALT lymphoma
Detailed Description:
Background In addition to Helicobacter pylori-negative gastric marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue named as MALT lymphoma Sci Rep 20177114333 the investigators recently demonstrated that first-line antibiotics treatments can cure around 50 patients with stage IEIIE1 extragastric MALT lymphoma 2018 ESMO poster discussion However the optimal management for antibiotics-unresponsive MALT lymphomas is not clearly defined
Rationale The investigators previously reported that thalidomide resulted in an overall response rate ORR including complete remission CR and partial remission PR of 50 in 10 patients with antibiotics-unresponsive or chemotherapy-resistant MALT lymphoma Lenalidomide an immunomodulatory derivatives IMiDs of thalidomide exhibits anti-angiogenic and immunomodulatory effects and has been proved efficacies in the treatment of multiple myeloma MM In the previous phase II study single agent of lenalidomide resulted in ORR of 611 in 18 patients with MALT lymphoma In addition to kill lymphoma cells single low-dose cyclophosphamide is an option for restoring immune response in patients with advanced cancer The investigators also showed that low-dose cyclophosphamide 50 mg daily for 21 days every 28 days alone resulted in the ORR of 444 in 9 patients with antibiotics-unresponsive MALT lymphoma Previous studies also demonstrated that the addition of low-dose cyclophosphamide can overcome lenalidomide resistance in patients with MM
Hypotheses Considering that lenalidomide and cyclophosphamide are found to have anti-tumor effects in MALT lymphoma the investigators speculated that combined lenalidomide and low-dose cyclophosphamide can increase the ORR rate as well as dural time of tumor remission and avoid alternative treatments including radiotherapy or chemotherapy-related adverse effects in antibiotics-unresponsive relapsed or refractory extranodal MALT lymphoma
Methods Therefore in this proposal the investigators will design a prospective phase II study to evaluate the treatment efficacies of combination of oral lenalidomide and low-dose cyclophosphamide LC lenalidomide Leavdo 15 mg daily day 1 to day 21 cyclophosphamide Endoxan 50 mg daily day 1 to day 21 courses will be repeated every 28 days in patients with antibiotics-unresponsive relapsed or refractory extranodal MALT lymphoma The primary endpoint of this current study is ORR and the second endpoint is adverse effect The investigators will enroll 21 patients with antibiotics-unresponsive relapsed or refractory MALT lymphoma based on the Simon minimax two-stage design
The translational studies including predictive markers and immunological profiles BAFF-related canonical and non-canonical NF-κB signaling molecules and immune-related molecules markers will be included in the second points The investigators will further assess immune-related molecules of nucleated cells of whole blood using flow cytometry and analyze serum BAFF and cytokines
Rationale The investigators previously reported that thalidomide resulted in an overall response rate ORR including complete remission CR and partial remission PR of 50 in 10 patients with antibiotics-unresponsive or chemotherapy-resistant MALT lymphoma Lenalidomide an immunomodulatory derivatives IMiDs of thalidomide exhibits anti-angiogenic and immunomodulatory effects and has been proved efficacies in the treatment of multiple myeloma MM In the previous phase II study single agent of lenalidomide resulted in ORR of 611 in 18 patients with MALT lymphoma In addition to kill lymphoma cells single low-dose cyclophosphamide is an option for restoring immune response in patients with advanced cancer The investigators also showed that low-dose cyclophosphamide 50 mg daily for 21 days every 28 days alone resulted in the ORR of 444 in 9 patients with antibiotics-unresponsive MALT lymphoma Previous studies also demonstrated that the addition of low-dose cyclophosphamide can overcome lenalidomide resistance in patients with MM
Hypotheses Considering that lenalidomide and cyclophosphamide are found to have anti-tumor effects in MALT lymphoma the investigators speculated that combined lenalidomide and low-dose cyclophosphamide can increase the ORR rate as well as dural time of tumor remission and avoid alternative treatments including radiotherapy or chemotherapy-related adverse effects in antibiotics-unresponsive relapsed or refractory extranodal MALT lymphoma
Methods Therefore in this proposal the investigators will design a prospective phase II study to evaluate the treatment efficacies of combination of oral lenalidomide and low-dose cyclophosphamide LC lenalidomide Leavdo 15 mg daily day 1 to day 21 cyclophosphamide Endoxan 50 mg daily day 1 to day 21 courses will be repeated every 28 days in patients with antibiotics-unresponsive relapsed or refractory extranodal MALT lymphoma The primary endpoint of this current study is ORR and the second endpoint is adverse effect The investigators will enroll 21 patients with antibiotics-unresponsive relapsed or refractory MALT lymphoma based on the Simon minimax two-stage design
The translational studies including predictive markers and immunological profiles BAFF-related canonical and non-canonical NF-κB signaling molecules and immune-related molecules markers will be included in the second points The investigators will further assess immune-related molecules of nucleated cells of whole blood using flow cytometry and analyze serum BAFF and cytokines
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?:
None