Clinical Trials

4 studies in Myelodysplasia

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

   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

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   
   Scottsdale: Clinical Trials Office 507-538-7623
                       
   
   

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

   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

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   
   Scottsdale: Debbie Gallagher, RN
                       
   
   

   Request Information Online
3. 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
   Close

   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

   • Print Summary
   • View study details

   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

   Request Information Online
4. Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) Rochester, MN View Summary
   Close

   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

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Anne Kuan
                       
   
   
   

   Request Information Online