Ignite Creation Date:
2024-05-05 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00609869
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2008-01-24
Brief Title:
Lenalidomide in Comb wRituximab for Pts wCD5CD20 Hem Malignancies Who RelapseProgress After Rituximab
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Lenalidomide REVLIMID in Combination With Rituximab for Patients With CD5CD20 Hematologic Malignancies Who Relapse or Progress After Rituximab
Status:
COMPLETED
Status Verified Date:
2015-09
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:
The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid in the treatment of refractory Mantle Cell Lymphoma MCL and Chronic Lymphocytic Leukemia CLL Revlimid is a drug that changes the immune system and it may also get in the way with the growth of tiny blood vessels that help support tumor growth Therefore in theory it may reduce or prevent the growth of cancer cells Revlimid is approved by the Food and Drug Administration FDA for the treatment of specific types of Myelodysplasia syndrome MDS and Multiple Myeloma two different types of blood cancer It is currently being tested in a variety of cancer conditions In this case it is considered experimental
Detailed Description:
This phase II trial will use a Simons two stage design enrolling a total of 28 subjects Ten will be accrued during stage 1 and 18 during stage 2 If 3 or fewer responses CRPR are observed during the first stage then the trial is stopped early Given that the true response probability is 30 there is a 6496 probability of ending the trial during stage 1 However if the true response probability is 60 then there is a 548 probability that the trial will be stopped in stage 1 If more than 3 responses are observed in stage 1 another 18 patients will be accrued in stage 2 If 12 or fewer responses are observed by the end of the trial then no further investigation of the drug is warranted Otherwise conclude that the drug is worthy of further investigation The alpha level of the design is 004 and the power is 091
Patients with confirmed CD5CD20 MCL or CLL who have relapsed or progressed after Rituximab therapy following a minimum of 6 months duration of response SD PR or CR as defined by Appendix D will be eligible for this study Baseline evaluation of patients prior to enrollment in this study will include complete blood counts CBCs serum chemistries liver function tests kidney function tests lactate dehydrogenase LDH and CT scans of the chest abdomen and pelvis and bone marrow biopsy The exact values for the status of organ function allowable on this protocol are included in the body of this document Bone marrow aspirates biopsies and standard FISH evaluation for specific cytogenetic abnormalities will be obtained by the clinical site An adequate bone marrow aspirate sample is required for a subject to be eligible to participate in this study All assessments will be completed according to Schedule of Study Assessments
Patients who meet eligibility criteria and have signed the informed consents will have further laboratory evaluation which will involve flow cytometry of the peripheral blood to evaluate 1 CD20 density on the leukemic cells CLL patients only 2 the percentage of CD56 cells to evaluate the baseline level of natural killer NK cell 3 the density of activation antigens CD2 CD11a CD31 CD38 and CD69 on CD56 cells and 4 CD38 ZAP-70 expression Pretreatment serum baseline values for Interferon-alpha IFN-alpha Tumor necrosis factor-alpha TNF-A granulocyte-macrophage colony-stimulating factor GM-CSF IL-6 and soluble IL-2 receptor will be obtained A baseline CBC flow cytometry and cytokine studies will be obtained on Day 1 prior to start of Lenalidomide
All patients will have a full immunological evaluation on Day 15 of Lenalidomide therapy prior to Rituximab administration A bone marrow biopsy will be performed on all patients CLL and MCL with prior documented bone marrow involvement once between Days 13- 15 to assess the impact of the lenalidomide on the malignant cells and the surface density of CD20 for patients with CLL before the administration of Rituximab Flow cytometry on the aspirate specimen will be performed at Moffitt Cancer Center The cytokine studies will be drawn on Day 15 prior to the administration of Rituximab Starting on Day 15 after collection of specimens the patients will receive four weekly doses of Rituximab 375 mgm2 concurrent with lenalidomide as per the cycle schedule Lenalidomide therapy will be continued until progression of disease unacceptable toxicity or patient withdrawal
Patient assessment during the clinical trial will be performed by a physician and will occur prior to the administration of each dose of Rituximab The evaluation will include CBC routine chemistries kidney function liver function and LDH The impact of the treatment on any lymphadenopathy or splenomegaly will be documented Any toxicities noted during these evaluations will be noted After the four weekly doses of Rituximab if the pretreatment bone marrow biopsy was positive the patient will have a repeat bone marrow biopsy to assess response If the patient had splenomegaly or lymphadenopathy prior to entry into the trial the patient will need repeat CT scans to assess response The scans and bone marrow biopsies should be performed two weeks after the patients last dose of Rituximab
Follow-up of patients after completing the Rituximab treatment for patients who have not progressed while on therapy will involve a CBC routine chemistries liver function tests and LDH drawn according to the Schedule of Assessments
Patients with confirmed CD5CD20 MCL or CLL who have relapsed or progressed after Rituximab therapy following a minimum of 6 months duration of response SD PR or CR as defined by Appendix D will be eligible for this study Baseline evaluation of patients prior to enrollment in this study will include complete blood counts CBCs serum chemistries liver function tests kidney function tests lactate dehydrogenase LDH and CT scans of the chest abdomen and pelvis and bone marrow biopsy The exact values for the status of organ function allowable on this protocol are included in the body of this document Bone marrow aspirates biopsies and standard FISH evaluation for specific cytogenetic abnormalities will be obtained by the clinical site An adequate bone marrow aspirate sample is required for a subject to be eligible to participate in this study All assessments will be completed according to Schedule of Study Assessments
Patients who meet eligibility criteria and have signed the informed consents will have further laboratory evaluation which will involve flow cytometry of the peripheral blood to evaluate 1 CD20 density on the leukemic cells CLL patients only 2 the percentage of CD56 cells to evaluate the baseline level of natural killer NK cell 3 the density of activation antigens CD2 CD11a CD31 CD38 and CD69 on CD56 cells and 4 CD38 ZAP-70 expression Pretreatment serum baseline values for Interferon-alpha IFN-alpha Tumor necrosis factor-alpha TNF-A granulocyte-macrophage colony-stimulating factor GM-CSF IL-6 and soluble IL-2 receptor will be obtained A baseline CBC flow cytometry and cytokine studies will be obtained on Day 1 prior to start of Lenalidomide
All patients will have a full immunological evaluation on Day 15 of Lenalidomide therapy prior to Rituximab administration A bone marrow biopsy will be performed on all patients CLL and MCL with prior documented bone marrow involvement once between Days 13- 15 to assess the impact of the lenalidomide on the malignant cells and the surface density of CD20 for patients with CLL before the administration of Rituximab Flow cytometry on the aspirate specimen will be performed at Moffitt Cancer Center The cytokine studies will be drawn on Day 15 prior to the administration of Rituximab Starting on Day 15 after collection of specimens the patients will receive four weekly doses of Rituximab 375 mgm2 concurrent with lenalidomide as per the cycle schedule Lenalidomide therapy will be continued until progression of disease unacceptable toxicity or patient withdrawal
Patient assessment during the clinical trial will be performed by a physician and will occur prior to the administration of each dose of Rituximab The evaluation will include CBC routine chemistries kidney function liver function and LDH The impact of the treatment on any lymphadenopathy or splenomegaly will be documented Any toxicities noted during these evaluations will be noted After the four weekly doses of Rituximab if the pretreatment bone marrow biopsy was positive the patient will have a repeat bone marrow biopsy to assess response If the patient had splenomegaly or lymphadenopathy prior to entry into the trial the patient will need repeat CT scans to assess response The scans and bone marrow biopsies should be performed two weeks after the patients last dose of Rituximab
Follow-up of patients after completing the Rituximab treatment for patients who have not progressed while on therapy will involve a CBC routine chemistries liver function tests and LDH drawn according to the Schedule of Assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RV-CLL-PI-067 | OTHER | Celgene | None |