Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I/II Trial of Maintenance Therapy With Lenalidomide and Rituximab Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-cell Non-Hodgkin Lymphoma
RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor.
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some
block the ability of cancer cells to grow and spread. Others find cancer cells and help kill
them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab
may be an effective treatment for B-cell non-Hodgkin lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide
when given together with rituximab as maintenance therapy in treating patients with B-cell
non-Hodgkin lymphoma.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Understand and voluntarily sign an informed consent form - Able to adhere to the study visit schedule and other protocol requirements - Histologic diagnosis of CD20+ B-cell NHL including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and other B-cell lymphomas excluding chronic lymphocytic leukemia - Received high-dose chemotherapy with autologous stem cell transplantation (ASCT) from 42 to 128 days before enrollment with stable disease, partial response or complete response following ASCT - All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study - ECOG performance status of =< 2 at study entry; Karnofsky performance status of >= 70% at study entry - Absolute neutrophil count >= 1,500/mm^3 - Platelet count >= 75,000/mm^3 - Serum creatinine =< 2.0 mg/dL - Phase I subjects must have estimated or measured creatinine clearance >= 60 ml/min - Phase II subjects must have estimated or measured creatinine clearance >= 30 ml/min - Total bilirubin =< 1.5 mg/dL - AST (SGOT) and ALT (SGPT) =< 2 x ULN or =< 5 x ULN if hepatic metastases are present - Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days) - Must also either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide - FCBP must also agree to ongoing pregnancy testing - Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy - Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to ASA may use warfarin or low molecular weight heparin) - All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that in the opinion of the investigator would prevent the subject from providing written informed consent - Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide) - Use of any other experimental drug or therapy within 28 days of baseline - Known hypersensitivity to thalidomide - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs - Known hypersensitivity to rituximab - Concurrent use of other anti-cancer agents or treatments - Known positive for HIV or infectious hepatitis, type B or C - Residual grade 3 or grade 4 non-hematologic toxicity after ASCT - Transfusion requirement (red blood cells or platelets) within 14 days prior to baseline - Use of hematopoietic growth factor (including filgrastim, pegfilgrastim, sargramostim, erythropoietin, or darbepoetin) within 14 days prior to baseline - Any other condition not defined above, including the presence of laboratory abnormalities, which in the opinion of the investigator would place the subject at unacceptable risk if he/she were to participate in the study, or would confound the ability to interpret data from the study - Prior use of lenalidomide either concurrently with rituximab or within 8 weeks following a dose of rituximab - Concomitant use of other anti-cancer therapies, including radiation, thalidomide, or other investigational agents is not permitted while subjects are receiving protocol therapy during the treatment phase of the study - Corticosteroid therapy also is not permitted while subjects are receiving protocol therapy during the treatment phase of the study |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
| United States | Fairview Cancer Hospital | Cleveland | Ohio |
| United States | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Case Comprehensive Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum tolerated dose of lenalidomide (Phase I) | 24 months | Yes | |
| Primary | Proportion of subjects who are able to complete 12 cycles of maintenance therapy with lenalidomide and rituximab after autologous stem cell transplantation (ASCT)(PHASE II) | 1 year | No | |
| Secondary | Progression-free survival after ASCT | 24 months | No | |
| Secondary | Evaluation of potential differences in effects of lenalidomide and rituximab on progression-free survival after ASCT according to histologic subtypes of B-cell NHL | 24 months | No | |
| Secondary | Overall response rate associated with treatment with lenalidomide and rituximab after ASCT, defined as the proportion of subjects with measurable disease at enrollment who achieve a partial response or complete response | 6-12 months | No | |
| Secondary | Enumeration of peripheral blood lymphocyte subsets by flow cytometry, including T cells, B cells, and NK cells and analysis of potential associations between these levels with progression-free survival | At study entry, 1 month, and 1 year | No | |
| Secondary | Analysis of FCgammaRIIIa receptor sequences in enrolled subjects to determine the presence or absence of FCgammaRIIIa-158 polymorphisms (V/V, V/F, and F/F); determining potential associations of these polymorphisms with progression-free survival | 12 months | No | |
| Secondary | Incidence of non-relapse mortality (NRM) defined as death from any cause other than B-cell NHL | At 6 and 12 months | No | |
| Secondary | Incidence of unacceptable toxicity during study treatment | At 6 and 12 months | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04635683 -
Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
|
Phase 1 | |
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Active, not recruiting |
NCT02153580 -
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT01955499 -
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
|
Phase 1 | |
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT00383565 -
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT00253630 -
Vorinostat in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00006473 -
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
| Active, not recruiting |
NCT01318317 -
Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
| Completed |
NCT01921387 -
Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01815749 -
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
|
Phase 1 | |
| Recruiting |
NCT04007029 -
Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Completed |
NCT01267812 -
Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
|
Phase 2 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 |