Clinical Trials

6 studies in Myelodysplastic Syndrome

1. Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts Rochester, MN View Summary
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   Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This is a Phase III open-label, randomized, controlled, multicenter study (up to 50 centers). Approximately 270 patients with MDS classified as RAEB-1 and RAEB-2 using the WHO classification and as RAEB-t and chronic myelomonocytic leukemia (CMML) using the FAB classification who failed, became intolerant to, or progressed after treatment with 5-azacitidine or decitabine administered during the past 2 years, will be randomized in a 2:1 ratio into the following 2 treatment regimens: - Best Supportive Care (BSC) + ON 01910.Na 1800 mg/24 hr administered as a 72-hr continuous intravenous (CIV) infusion on Days 1, 2, and 3 of a 2-week cycle (N = approximately 180 patients) - BSC (N = approximately 90 patients). Patients will be stratified at entry by bone marrow (BM) blasts (5% to 19% vs. 20% to 30%). After completing the first eight 2-week cycles (i.e., after 16 weeks of treatment), the frequency of further 72-hr CIV infusions will be decreased to an administration on Days 1, 2, and 3 of a 4-week cycle. Patients will remain treated on study until 2006 International Working Group (IWG) progression criteria are met (i.e., 50% increase of BM blasts or worsening of cytopenias) or until death from any cause, whichever comes first. Patients who progress to Acute Myeloid Leukemia (AML) while on study should be offered either standard treatment for AML or enrollment in an appropriate investigational study if they are eligible. These treatments with their start and end dates should be documented and patient survival time will be documented for all randomized patients. Cross-over of BSC patients to ON 01910.Na after progression will not be allowed. However, patients in the BSC-only group will be allowed, as medically justified, access to low-dose cytarabine 20 mg/m2 subcutaneously (SC) once daily for the first consecutive 14 days of each 28-day cycle, up to 4 cycles, until progression or unacceptable toxicity develops. Low-dose cytarabine will be delayed as needed until recovery of blood counts. All study participants will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (erythropoietin, Filgrastim [G-CSF]). Hydroxyurea will be allowed to manage blastic crisis with hyperleukocytosis when patients transition to leukemia.

   NCT ID:

   NCT01241500

   IRB Number:

   11-002760

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   Who can I contact for additional information about this study?

   - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu

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2. Reduced Intensity Conditioning Versus Myeloablative Conditioning for Acute Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901) Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Reduced Intensity Conditioning Versus Myeloablative Conditioning for Acute Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Patients randomized to RIC will receive one of two regimen types: the combination of fludarabine (120-180 mg/m^2) and busulfan (less than or equal to 8 mg/kg or IV equivalent) (Flu/Bu) or fludarabine (120-180 mg/m^2) and melphalan (less than 150 mg/m^2) (Flu/Mel). Patient randomized to MAC will receive one of three regimens: busulfan (16 mg/kg oral or 12.8 mg/kg IV equivalent) and cyclophosphamide (120 mg/kg) (Bu/Cy); or, busulfan (16 mg/kg PO or 12.8 mg/kg IV) and fludarabine (120-180 mg/m^2) (Bu/Flu); or, cyclophosphamide (120 mg/kg) and total body irradiation (greater than 1200-1420cGy) (CyTBI). A total of 356 patients (178 to each arm) will be accrued on this study over a period of four years. Patients will be followed for up to 18 months from transplantation.

   NCT ID:

   NCT01339910

   IRB Number:

   11-002298

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   Who can I contact for additional information about this study?

   
   Scottsdale: Clinical Trials Office 507-538-7623
                       
   
   

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3. SGI-110 in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Scottsdale and Phoenix, AZ View Summary
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   SGI-110 in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Once the BED and MTD is determined in the Dose Escalation Segment, the Dose Expansion Segment will randomize patients with MDS, treatment naïve elderly AML, and relapsed/refractory AML patients to receive the BED or MTD dose. Relapsed/refractory AML patients may also receive SGI-110 on a daily x 10 schedule based on the total dose per cycle evaluated in the Dose Escalation Segment using the 5-daily regimen.

   NCT ID:

   NCT01261312

   IRB Number:

   11-001403

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   Who can I contact for additional information about this study?

   
   Scottsdale: Debbie Gallagher, RN
                       
   
   

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4. Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To test whether the response rate (complete remission, partial remission, or hematologic improvement) of patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who receive either the combination of lenalidomide and azacitidine or the combination of vorinostat and azacitidine is improved compared to patients who receive single-agent azacitidine. II. To estimate relapse-free survival, overall survival and cytogenetic response rate of patients treated on each regimen. III. To estimate the frequency and severity of toxicities of the three regimens in this patient population. IV. To investigate in a preliminary manner the frequency of subgroups from pre-study cytogenetic studies and correlate these subgroups with clinical outcomes in this patient population. V. To collect specimens for banking for use in future research studies. OUTLINE: Patients are randomized to 1 of 3 treatment arms. 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, courses repeat 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.

   NCT ID:

   NCT01522976

   IRB Number:

   12-003338

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   Who can I contact for additional information about this study?

   Rochester: Mrinal M. Patnaik 507-538-7623
                       
   Scottsdale: Mrinal M. Patnaik 507-538-7623
                       
   
   

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5. Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This will be a Phase II open-label, multicenter (up to 5 centers), single-arm study. Sixty transfusion-dependent patients with MDS classified as Low or Int-1 risk (any cytogenetics) or trisomy 8 Int-2 by International Prognostic Scoring System (IPSS) will be enrolled to receive on an outpatient basis 560 mg rigosertib BID for 14 consecutive days of a 21-day cycle. (Note: Protocol was amended to delete the arm in which administration of rigosertib was a continuous regimen on days 1 to 21 of 21-day cycle because higher incidence of urinary symptoms was observed in this arm.) Patients will be stratified on prior treatment with azacitidine and/or decitabine and/or lenalidomide and/or erythropoietin. Patients will remain treated on study until 2006 Internation Working Group (IWG) progression criteria are met or until death from any cause. All study participants will be allowed, as medically justified, access to RBC and platelet transfusions, and to filgrastim [G-CSF]. Erythropoiesis-stimulating agents (ESAs) will not be allowed during the initial 3 cycles and then will only be allowed in patients with hemoglobin levels of less than 9 g/dL. Rigosertib dosing adjustment policies are described in Protocol.

   NCT ID:

   NCT01584531

   IRB Number:

   12-001218

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   Who can I contact for additional information about this study?

   - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu

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6. Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) Rochester, MN View Summary
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   Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute leukemia and myelodysplastic syndrome during the first year after transplant. Patients meeting all the inclusion and none of the exclusion criteria will be randomized (1:1). All patients will receive premedication and study drug 3 days prior to transplantation.

   NCT ID:

   NCT01295710

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   Who can I contact for additional information about this study?

   Rochester: Anne Kuan
                       
   
   
   

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