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Study Title Principal Investigator
A Phase1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)
Dose levels for the study's second stage will be based on safety and pharmacokinetics.
Recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Mohammad Azab
A Phase II Simon Two-Stage Study of the Addition of Pracinostat to a Hypomethylating Agent (HMA) in Patients With Myelodysplastic Syndrome (MDS) Who Have Failed to Respond or Maintain a Response to the HMA Alone
Active, not recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Guillermo Garcia-Manero
A Phase 1b/2 Study To Evaluate The Safety And Efficacy Of Pf-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-c Or Decitabine In Patients With Acute Myeloid Leukemia Or High-risk Myelodysplastic Syndrome
Recruiting | Leukemia | Multisite
Pfizer Center
A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent
This is a Phase III, open-label, randomized, controlled, international study (approximately 100 sites). Approximately 225 patients < 80 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DEC for ≤ 9 months and had their last dose of AZA or DEC within 6 months prior to screening will be stratified by: - Very high risk (VHR) vs non-VHR per IPSS-R, and - Geographic region (North America vs Europe vs Asia; because approved products and standard of care may vary by region), and randomly assigned in a 2:1 ratio to one of the following 2 treatment groups: - Rigosertib 1800 mg/24 hr administered as a 72 hr CIV infusion on Days 1, 2, and 3 of a 2 week cycle for the first 8 cycles, and on Days 1, 2, and 3 of a 4-week cycle thereafter (N = approximately 150 patients); - Physician's Choice of alternative treatment, which may include any approved or standard-of-care therapy, based on frequently used treatment for MDS after receipt of HMAs (N = approximately 75 patients). Experimental therapies are not allowed on the PC arm. Patients will be treated until 2006 IWG progression criteria are met (ie, 50% increase of BM blasts or worsening of cytopenias) or until an unacceptable toxicity or intolerance. For all randomized patients who discontinue study treatment, subsequent therapies with their start and end dates, as well as survival time after treatment discontinuation, will be documented at least monthly until death. Patients in the PC group who progress will not be allowed to cross over to rigosertib. All patients in both treatment groups will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (granulocyte colony-stimulating factor (G-CSF), erythropoietin, and thrombopoietin).
Recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Steven Fruchtman
9L-15-10: A Phase 3, Multicenter, Randomized, Doubleblind Study to Compare the Efficacy and Safety of Oral Azacitidine plus Best Supportive Care versus Placebo plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-Dependent Anemia and Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic Syndromes
| Myelodysplastic Syndromes (MDS) | Multisite
Mojtaba Akhtari
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9L-14-6: A Randomized, Double-Blind Phase 1b/2 Study of PF-04449913 in Combination with Azacitidine in Patients with Previously Untreated Intermediate-2 or High-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia with 20-30% Blasts and Multi-Lineage Dysplasia, or Chronic Myelomonocytic Leukemia
PF-04449913 is a novel small molecule inhibitor of the Sonic Hedgehog (Hh) Pathway which is currently under development for the treatment of hematologic malignancies and solid tumors.This multi-center randomized (1:1), double-blind, placebo-controlled Phase 1b/2 study is designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04449913 or placebo when combined with azacitidine in patients with previously untreated Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, and Chronic Myelomonocytic Leukemia (CMML).This clinical study includes two components: (a) a Phase 1b safety lead-in and (b) a randomized Phase 2.Primary Objective is to assess the safety and tolerability of PF-04449913 when administered in combination with azacitidinePrimary endpoint is adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Casey O'Connell
9L-16-4-A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) In Combination with Azacitidine in Patients with Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 Or High Risk Myelodysplastic Syndrome (MDS)
In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.
| Myelodysplastic Syndromes (MDS) | Multisite
Casey O'Connell
9L-11-2: A Multi-Center, Randomized, Double-Blind, Placebocontrolled Clinical Trial of Deferasirox in Patients with Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload (TELESTO) CICL670A2302
Active, not recruiting | Myelodysplastic Syndromes (MDS) | Multisite
Vinod Pullarkat
SWOG-S1117: A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
PRIMARY OBJECTIVES: I. To select based on response rate (complete remission, partial remission, or hematologic improvement) either the combination of lenalidomide and azacitidine or the combination of vorinostat and azacitidine for further testing against single-agent azacitidine among patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). (Phase II) II. To compare overall survival between the combination arm selected in the Phase II portion of the trial to single-agent azacitidine among patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). (Phase III) SECONDARY OBJECTIVES: I. To estimate relapse-free survival, overall survival and cytogenetic response rate of patients treated on each regimen. II. To estimate the frequency and severity of toxicities of the three regimens in this patient population. III. To investigate in a preliminary manner the frequency of subgroups from prestudy cytogenetic studies and correlate these subgroups with clinical outcomes in this patient population. IV. To collect specimens for banking for use in future research studies. TERTIARY OBJECTIVES: I. To evaluate the prevalence of a pre-specified list of molecular lesions (48 total lesions). II. To assess associations of these lesions with outcomes (response, event-free survival, relapse-free survival, and overall survival). III. To develop a deoxyribonucleic acid (DNA) methylation biomarker predictive of response to DMTi treatment in MDS. IV. To harness gene expression profiles as clinical biomarkers of primary resistance to DMTi in MDS. OUTLINE: Patients are randomized to 1 of 3 treatment arms. In Phase III, patients are randomized to 1 of 2 treatment arms (the combination arm selected in Phase II or the single-agent azacitidine arm). ARM I: Patients receive azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 or days 1-5 and 8-9, and lenalidomide orally (PO) once daily (QD) on days 1-21. ARM II: Patients receive azacitidine as in Arm I. ARM III: Patients receive azacitidine as in Arm I and vorinostat PO twice daily (BID) on days 3-9. In all arms, treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 5 years.
Active, not recruiting | Leukemia | Multisite
Sikander Ailawadhi
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