Myelodysplastic Syndrome Clinical Trial
Official title:
A Phase I/II Optimal Dose Study of Lenalidomide in the Non-5q- LOW and INT-1 Risk MDS Patients
Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality called "deletion 5q" in Low and Intermediate-1 (INT-1) patients (staging system according to International Prognostic Scoring System (IPSS)). The purpose of this Phase I/II study is to determine the optimal dose of Revlimid® (Lenalidomide) in MDS Low and MDS INT-1 patients without deletion 5q by slowly increasing the dose while monitoring blood counts for safety evaluation as well as observe other adverse events. Efficacy will also be observed for the phase II portion of the study.
There are little options for non deletion 5q Low and INT-1 patients. This study aims to find
an early clinical signal for higher activity and better response with lenalidomide in
patients with non deletion 5q Low and INT-1 MDS patients. Lenalidomide is an
immunomodulatory agent. Thalidomide, the parent compound, has both immunomodulatory and
anti-angiogenic properties which could confer anti-tumor and anti-metastatic efforts.
Lenalidomide has been demonstrated to possess anti-angiogenic activity through inhibition of
basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF) and tumor
necrosis factor-alpha (TNF-alpha) induced endothelial cell migration (movement of cells in
preparation to form new abnormal blood vessels for cancer cells), due at least in part to
inhibition of Akt phosphorylation response to bFGF.
In addition, lenalidomide has a variety of immunomodulatory effects. Lenalidomide stimulates
T cell proliferation, and the production of interleukin-2 (IL-2), IL-10 and interferon-gamma
(IFN-gamma), inhibits IL-1 beta and IL-6 and modulated IL-12 production.
Although the exact anti-tumor mechanism of action of lenalidomide is unknown, a number of
mechanisms are postulated for the activity of Lenalidomide in MDS.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Completed |
NCT01200355 -
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
|
Phase 4 | |
| Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
| Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
| Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
| Completed |
NCT03941769 -
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II
|
Phase 1/Phase 2 | |
| Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
| Recruiting |
NCT06195891 -
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
| Completed |
NCT00987480 -
Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
|
Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
| Completed |
NCT02756572 -
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
|
Phase 2 | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
| Completed |
NCT02262312 -
Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
|
Phase 0 | |
| Completed |
NCT02188290 -
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
|
N/A | |
| Recruiting |
NCT02330692 -
Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
|
||
| Completed |
NCT01684150 -
A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving
|
Phase 1 |