Clinical Trials

14 studies in Acute Myelogenous Leukemia

1. Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia Rochester, MN View Summary
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   Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - To define the relationship between the status of donor NK-cell receptor and patient outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor (URD) and umbilical cord blood (UCB) hematopoietic cell transplantation (HCT) in young patients with acute myeloid leukemia with monosomy 7, -5/5q-, high FLT3 internal tandem duplication allelic ratio (High-FLT3-ITD AR), or refractory or relapsed acute myelogenous leukemia. - To correlate the relationships between factors affecting NK receptor status and clinical events. - To assess NK-cell development after URD and UCB HCT in patients with poor prognosis AML. - To evaluate NK-cell reconstitution and receptor-acquisition pattern in these patients. OUTLINE: This is a multicenter study. - Preparative regimen: Patients receive 1 of the following regimens: - Hematopoietic stem cell transplantation (SCT): Patients receive busulfan IV every 6 hours on days -9 to -6, high-dose cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1, and methylprednisolone IV on days -3 to -1. - Umbilical cord blood (UCB) transplantantation: Conditioning regimen, infusion procedures, and post-transplant immunoprophylaxis for patients with an UCB donor are according to institutional guidelines and standards. - Allogeneic hematopoietic stem cell transplantation (SCT) or umbilical cord blood (UCB) transplant: Patients undergo allogeneic SCT or UCB transplant on day 0. - Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine or tacrolimus IV or orally beginning on day -2 and continuing until day 50, followed by a taper until week 24. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Blood samples will be collected periodically from both patients and donors for studies of natural killer cells in support of the study objectives. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

   NCT ID:

   NCT00553202

   IRB Number:

   08-005561

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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2. Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Jacksonville, FL Rochester, MN View Summary
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   Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

   Location:

   Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To determine the CR + CRc + CRi rate of carboplatin and topotecan; flavopiridol, mitoxantrone and cytosine arabinoside and sirolimus, mitoxantrone, etoposide and cytosine arabinoside in adult patients with refractory or relapsed AML. II. To determine the rate of treatment failure of these regimens. III. To determine the incidence and severity of toxicities of these regimens. IV. To analyze the predictive value of blast cell properties that have been suggested to determine response. (Correlative laboratory studies) V. To determine whether pretreatment levels of Bcl-2 or, alternatively, whether a therapy-induced change in topoisomerase I levels correlates with response to this regimen. (Correlative laboratory studies) VI. To assess the impact of clonal evolution by comparing cytogenetic abnormalities at the time of relapse with those at initial diagnosis and correlating these abnormalities and changes with response to the treatment regimens in this protocol. (Cytogenetic and FISH Studies) VII. Panel FISH studies for common AML rearrangements will be performed on relapse AML specimens to determine the presence of these recurrent AML abnormalities and to evaluate for subtle additional abnormalities consistent with clonal evolution in these relapse specimens. (Cytogenetic and FISH Studies) OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease status (relapse ≤ 6 months after achieving first complete remission [CR] vs relapse between 6-12 months after achieving first CR vs refractory to ≤ 2 courses of initial conventional induction chemotherapy vs refractory to ≤ 1 course of first reinduction chemotherapy). Patients are randomized to 1 of 3 treatment arms. Induction therapy: ARM I: Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5. ARM II: Patients receive alvocidib IV over 4.5 hours once daily on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. ARM III: Patients receive oral sirolimus once daily on days 2-9, mitoxantrone hydrochloride IV over 15 minutes once daily, etoposide IV over 1 hour once daily, and cytarabine IV over 3 hours once daily on days 4-8 or 5-9. After completion of induction therapy, patients in all arms undergo bone marrow aspirate and biopsy. Patients with persistent leukemia (i.e., leukemic blasts ≥ 10%) are removed from study and are offered alternative therapy at the discretion of the investigator. Patients who achieve CR proceed to consolidation therapy or receive alternative therapy at the discretion of the investigator. CONSOLIDATION THERAPY: Beginning within 2-6 weeks after documentation of CR, patients may receive up to 2 additional courses of the same treatment they received during induction therapy. Courses repeat every 4-10 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for up to 3 years.

   NCT ID:

   NCT00634244

   IRB Number:

   08-007643

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   Who can I contact for additional information about this study?

   Rochester: Mark R. Litzow 507-538-7623
                       
   Scottsdale: Mark R. Litzow 507-538-7623
                       
   Jacksonville: Mark R. Litzow 507-538-7623
                       
   

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3. Clinical Study of PM01183 in Patients With Acute Leukemia Rochester, MN View Summary
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   Clinical Study of PM01183 in Patients With Acute Leukemia

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Open-Label, Dose-Escalating, Clinical and Pharmacokinetic Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered as 1-hour intravenous (i.v.) infusion on three consecutive days (Days 1-3) to patients with advanced acute leukemia and to assess the safety profile and tolerability, to obtain preliminary information on the efficacy and to characterize the pharmacokinetics (PK) and pharmacogenomic (PGx) profile of PM01183.

   NCT ID:

   NCT01314599

   IRB Number:

   11-000056

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   Who can I contact for additional information about this study?

   Rochester: Animesh Pardanani, M.D.
                       
   
   
   

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4. Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

   Location:

   Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To compare the overall survival of older patients with newly diagnosed acute myeloid leukemia (AML) treated with clofarabine as induction therapy and consolidation therapy vs standard daunorubicin hydrochloride and cytarabine. Secondary - To evaluate complete remission (CR) rates, duration of remission, and toxicity/treatment-related mortality of patients treated with these regimens. - To evaluate the feasibility of consolidation therapy with reduced-intensity conditioning and allogeneic hematopoietic stem cell transplantation from HLA-identical donors, in terms of the incidence of successful engraftment, acute and chronic graft-vs-host disease, and transplant-related mortality in select patients age 60-69 years who achieve a response to induction therapy. - To determine the impact of reduced-intensity conditioning and allogeneic stem cell transplantation on overall survival of select patients. - To compare the duration of remission and disease-free survival of patients in CR following completion of consolidation therapy who are subsequently randomized to receive decitabine as maintenance therapy vs observation. - To perform expression and methylation profiling in patients treated with decitabine as maintenance therapy and to correlate their integrated epigenetic signatures with response to decitabine. - To examine the epigenetic profiles of remission marrow in patients randomized to receive decitabine as maintenance therapy vs observation to determine whether epigenetic signatures of apparently morphologically normal bone marrow is predictive of relapse or response to decitabine. - To explore the possible association of response to clofarabine with nucleoside transporters hENT1, hCNT3, and ABC-transporter P-glycoprotein. - To assess the intensity of expression of CXCR4 on diagnostic leukemia cells and to correlate this parameter with other established prognostic factors. - To assess the entire spectrum of somatic mutations and affected pathways at diagnosis of AML and elucidate the association between gene mutation and outcome. Tertiary - To compare health-related quality of life (QOL) (physical, functional, leukemia-specific well-being) and fatigue in patients treated with clofarabine vs standard induction therapy. - To measure the change in health-related QOL that occurs over time. - To comprehensively assess patient function at the time of study enrollment. - To determine if components of a comprehensive geriatric assessment or QOL scale predict ability to complete treatment for AML. - To describe the impact of transplantation on QOL in patients with AML over 60 years of age. OUTLINE: This is a multicenter study. Patients are stratified according to age (60-69 years vs ≥ 70 years), , disease type (secondary vs de novo), therapy-related AML (yes vs no), and antecedent hematologic disorder (yes vs no). - Induction therapy: Patients are randomized to 1 of 2 treatment arms. - Arm I (standard therapy): Patients receive daunorubicin hydrochloride IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., < 5% blasts and < 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 14. - Arm II: Patients receive clofarabine IV over 1 hour on days 1-5. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., < 5% blasts and < 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 21 and no later than day 56. Patients who achieve a complete remission (CR) or CR incomplete (CRi) after induction therapy proceed to consolidation therapy. Patients who are 60-69 years of age who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to allogeneic stem cell transplantation. Patients undergoing second induction who do not achieve CR by day 56 of the start of re-induction are taken off protocol. - Consolidation therapy: Beginning within 60 days after documentation of CR or CRi, patients receive consolidation therapy in the same arm they were randomized to for induction therapy. - Arm I (standard therapy): Patients receive cytarabine IV over 1 hour once or twice daily on days 1-6. Treatment repeats every 4-6 weeks for 2 courses. - Arm II: Patients receive clofarabine IV over 1 hour on days 1-5. Treatment repeats every 4-6 weeks for 2 courses. Patients who remain in CR after completion of consolidation therapy proceed to maintenance therapy. - Maintenance therapy: Beginning within 60 days after completion of consolidation therapy, patients receive maintenance therapy and are randomized to 1 of 2 arms. - Arm I: Patients undergo observation monthly for 12 months. - Arm II: Patients receive decitabine IV over 1 hour on days 1-3. Treatment repeats every 4 weeks for 12 months the absence of unacceptable toxicity. - Allogeneic stem cell transplantation with reduced-intensity conditioning regimen: Patients begin reduced-intensity conditioning 30-90 days after the initiation of induction therapy. - Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours every 6 hours on days -4 and -3 (for a total of 8 doses), and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2. - Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients complete quality-of-life questionnaires periodically, including health-related quality of life, physical and functional well-being, and fatigue questionnaires. Peripheral blood, bone marrow, and karyotype samples are collected periodically for cytogenetic analysis and other correlative laboratory studies. After completion of study treatment, patients are followed up periodically for ≥ 5 years.

   NCT ID:

   NCT01041703

   IRB Number:

   11-000553

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   

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5. Selecting a Favorable KIR Donor in Unrelated HCT for AML Scottsdale and Phoenix, AZ View Summary
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   Selecting a Favorable KIR Donor in Unrelated HCT for AML

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.

   NCT ID:

   NCT01288222

   IRB Number:

   11-003033

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   Who can I contact for additional information about this study?

   
   Scottsdale: James Slack, MD
                       
   
   

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6. MLN8237 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia Rochester, MN View Summary
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   MLN8237 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To determine the objective response rate in pediatric patients with relapsed or refractory solid tumors or leukemia treated with aurora A kinase inhibitor alisertib (MLN8237). Secondary - To define and describe the toxicities of this regimen in these patients. - To characterize the pharmacokinetics of this regimen in these patients. - To evaluate aurora A kinase expression in tissue samples obtained at diagnosis and at relapse. - To explore the relationship between polymorphic variations in the UDP-glucuronosyltransferase gene UGT1A1 and exposure to MLN8237. - To assess two common polymorphic variants in the aurora A kinase gene (Phe31Ile and Val57Ile) associated with tumorigenesis. OUTLINE: This is a multicenter study. Patients are stratified according to type of tumor ( measurable neuroblastoma vs neuroblastoma with MIBG-positive lesions vs osteosarcoma vs Ewing sarcoma/PNET vs rhabdosarcoma vs non-RMS soft tissue sarcoma vs hepatoblastoma vs rhabdoid tumor vs malignant germ cell tumor vs Wilms tumor vs AML vs ALL). Patients receive oral alisertib once daily on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. Plasma samples are collected from all patients at baseline and periodically during course 1 for pharmacokinetic and other studies. After completion of study therapy, patients are followed up for 5 years.

   NCT ID:

   NCT01154816

   IRB Number:

   11-002141

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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7. A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia Rochester, MN View Summary
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   A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This is a multicenter, randomized, Phase 3 study comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

   NCT ID:

   NCT01303796

   IRB Number:

   11-001508

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office 507-538-7623
                       
   
   
   

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8. 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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9. 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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10. Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy Rochester, MN View Summary
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    Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - To determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence of proven or probable invasive fungal infections (IFI) compared with fluconazole. Secondary - To determine if prophylaxis with caspofungin will result in a lower incidence of proven or probable cases of invasive aspergillosis (IA) compared with fluconazole. - To determine if prophylaxis with caspofungin will result in improved survival compared to fluconazole. - To determine if prophylaxis with caspofungin will result in less empiric antifungal therapy compared to fluconazole. - To determine the sensitivity, specificity, and positive and negative predictive value of biweekly galactomannan (GM) and beta-D glucan testing in diagnosing IFI. - To test the association between single nucleotide polymorphisms (SNPs) in genes involved in innate immunity and proven or probable IFI. - To develop predictive models of IFI using SNP in genes involved in immunity and clinical covariates. OUTLINE: This is a multicenter study. Patients are stratified according to disease (de novo acute myeloid leukemia vs all other patients). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24-72 hours after the last dose of chemotherapy for each course and continuing until ANC > 100-500/μL, the next chemotherapy course begins, or patient meets any off-protocol criteria. - Arm II: Patients receive fluconazole IV over 2 hours or orally (PO) QD beginning within 24-72 hours after the last dose of chemotherapy for each course and continuing until ANC > 100-500/μL, the next chemotherapy course begins, or patient meets any off-protocol criteria. In both arms, treatment continues in the absence of invasive fungal infections or disease progression. Blood samples may be collected twice weekly for antifungal antigen assays and at the end of course 1 for single nucleotide polymorphism analysis. After completion of study treatment, patients are followed up periodically for 2 years.

    NCT ID:

    NCT01307579

    IRB Number:

    11-007044

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    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        
    
    
    

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