Clinical Trials

Researchers are continually testing new treatments for MDS, and many of these studies originate at the Albert Einstein College of Medicine. These investigational approaches are offered to eligible patients here through the clinical trial process, which is designed to advance the current standard of care for MDS. By treating patients with MDS in clinical trials, physicians have shown that 5-azacytidine, decitabine, and lenalidomide are safe and effective treatments for MDS. These clinical trials led to FDA approval of these drugs, and in this same way, we hope to develop even better treatments for MDS.

As with all cancer treatment, clinical trials involve a team approach, in which physicians, scientists, and pathologists work together to care for each patient. We are experts at determining which patients will derive the most benefit from which trial.

 

Clinical Trials at the Albert Einstein Cancer Center

NCI 6898: Phs. I-II Study of Vorinostat [Suberoylanilide Hydroxamic Acid (SAHA)] in Combination W/Azacitidine in Patients W/Myelodysplastic Syndrome (MDS)
To determine safe doses of vorinostat (SAHA) and azacitidine in patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia, and to determine the safety, toxicity, and response rate of this regimen in these patients.
Accrual suspended
E1905: Rand. Phs. II Trial of Azacitidine with or without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (dysplastic type), and Acute Myeloid Leukemia with Multilineage Dysplasia
To compare the overall response rate (complete, partial, and hematologic improvement-major by International Working Group [IWG] criteria) in patients with treatment-induced or non-treatment-induced myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (dysplastic), or acute myeloid leukemia with multilineage dysplasia treated with azacitidine with vs without MS-275.
Closed to accrual
20060198 Rand., D/B, Placebo Controlled Stdy. Evaluating the Efficacy & Safety of Romiplostim Treatment of Thrombocytopenia in Subjects W/Low or Intremediate-1 Risk Myelodysplasic Syndrome (MDS)
To evaluate the efficacy of romiplostim for the treatment of thrombocytopenia in subjects with international prognostic scoring system (IPSS) low or intermediate-1 risk MDS as measured by the number of clinically significant bleeding events.
Closed to accrual
PMA112509 Phs. I/II Study of Eltrombopag in Thrombocytopenic Subjects W/Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia after MDS (sAML/MDS)
This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation.This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.
Open to accrual
E2905: Rand. Phs. III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment W/Lenalidomide (Revlimid) Alone & in Combination W/Epoetin Alfa (Procrit) in Subjects W/Low-or Intermediate-1 Risk MDS & Symptomatic Anemia
Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cell. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.This randomized phase III trial is studying lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
Open to accrual
MEK 111759 O/L, D/E, Phs. I/II Stdy to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, & Clinical Activity of the MEK Inhibitor GSK 1120212 in Sjts. W/Relapsed or Refractory Leukemias
MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles.This study will identify the maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose escalations will continue based on predefined parameters until a maximum tolerated dose is established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or refractory acute myeloid leukaemia will be determined.
Open to accrual
Role of p38 MAP Kinase in Myelodysplastic Syndromes and Anemias
To determine the role of p38 MAP Kinase signaling pathways in the pathogenesis of myelodysplasia (MDS) and other bone marrow failure disorders.
Open to accural
Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
Opening shortly
A Phase 2 Study of Jak2 inhibitor, LY2784544, in Patients with Myeloproliferative diseases
 
Opening shortly
Phase II study of combination of Eltrombopag and Lenalidomide in Transfusion dependant cases of Low/Int-1 MDS
 
Opening shortly

Updated 11/30/11