Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase II Study to Assess Immunosuppression With Sirolimus Combined With Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) for Prevention of Acute GVHD After Non-Myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation- A Multi-Center Trial
This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To determine whether the incidence of acute GVHD grades II-IV can be reduced to less than
the historical rate of 70% with the triple-immunosuppressant combination of cyclosporine
(CSP)/mycophenolate mofetil (MMF) with sirolimus in human leukocyte antigens (HLA) class I or
class II mismatched related or unrelated donor hematopoietic cell transplantation (HCT) using
nonmyeloablative conditioning. The evaluation will be carried out separately among class I
and class II mismatched patients.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of non-relapse mortality before day 100.
II. To evaluate the incidences of grades III-IV acute GVHD.
OUTLINE:
CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on
days -4 to -2. Patients also undergo total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.
IMMUNOSUPPRESSION: Patients receive sirolimus orally (PO) once daily (QD) on days -3 to 180
with taper to day 365; cyclosporine PO twice daily (BID) on days -3 to 150 with taper to day
180; and mycophenolate mofetil PO thrice daily (TID) on days 0-30 and then BID to day 100
with taper to day 150.
After completion of study treatment, patients are followed up at 6 months and every year
thereafter.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
| Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
| Active, not recruiting |
NCT04240704 -
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL
|
Phase 1 | |
| Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03280160 -
Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab
|
Phase 2 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT00038025 -
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
|
Phase 2 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Terminated |
NCT02231853 -
Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections
|
Phase 1 | |
| Recruiting |
NCT05417165 -
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
|
Phase 2 | |
| Recruiting |
NCT04028531 -
Understanding Chronic Lymphocytic Leukemia
|
||
| Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
| Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Recruiting |
NCT04679012 -
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
|
Phase 2 | |
| Recruiting |
NCT05405309 -
RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05023980 -
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
|
Phase 3 | |
| Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
| Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|