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Evoltra Medical Research Studies

Up-to-date List of Evoltra Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Evoltra Medical Research Studies

Rank Status Study
1 Recruiting Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome
Condition: Leukemia
Interventions: Drug: Clofarabine;   Drug: Idarubicin;   Drug: Cytarabine;   Drug: Fludarabine
Outcome Measures: Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine;   Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) versus Fludarabine, Idarubicin, and Cytarabine (FLAI)
2 Recruiting Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas
Condition: Lymphoma
Interventions: Drug: Gemcitabine;   Drug: Clofarabine;   Drug: Busulfan;   Procedure: Stem Cell Infusion;   Drug: Anti-Thymocyte Globulin;   Drug: Rituximab;   Drug: Filgrastim;   Drug: Tacrolimus;   Drug: Mycophenolate Mofetil
Outcome Measures: Maximum Tolerated Dose (MTD) of Infusional Gemcitabine;   Success Rate
3 Not yet recruiting A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids - Mixed Phenotype Acute Leukemia (MPAL)
Condition: Leukemia
Interventions: Drug: Clofarabine;   Drug: Idarubicin;   Drug: Cytarabine;   Drug: Vincristine;   Drug: Rituximab
Outcome Measure: Response Rate
4 Recruiting Fludarabine/Clofarabine/Busulfan Combined With SAHA in Acute Leukemia
Condition: Leukemia
Interventions: Drug: Fludarabine;   Drug: Clofarabine;   Drug: Busulfan;   Drug: SAHA;   Procedure: Stem Cell Infusion (SCT);   Drug: Thymoglobulin
Outcome Measure: Maximum Tolerated dose (MTD) of SAHA in Combination with Fludarabine, Clofarabine, and Busulfan
5 Recruiting Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)
Conditions: Leukemia;   Myeloproliferative Diseases
Interventions: Drug: Clofarabine;   Drug: Cytarabine
Outcome Measures: Number of Participants with Complete Response (CR);   Overall Survival (OS)
6 Not yet recruiting Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
Interventions: Drug: Clofarabine;   Drug: Cytarabine
Outcome Measures: complete response;   Number of participants with adverse events;   Length of survival;   Relapse free survival;   Predictive factors for response to treatment
7 Recruiting Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Conditions: Disorder Related to Bone Marrow Transplantation;   Leukemia;   Transplantation Infection
Interventions: Drug: Fludarabine;   Drug: Clofarabine;   Drug: Busulfan;   Drug: Thymoglobulin;   Procedure: Stem Cell Infusion;   Drug: Tacrolimus;   Drug: Methotrexate
Outcome Measures: Progression-Free Survival (PFS);   Overall Survival (OS)
8 Recruiting Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia
Conditions: Acute Lymphoblastic Leukemia;   Acute Myelogenous Leukemia;   Lymphoblastic Lymphoma;   Diffuse Large B-cell Lymphoma;   Burkitt Lymphoma/Leukemia
Interventions: Drug: Clofarabine;   Drug: Mitoxantrone
Outcome Measures: Determine MTD;   Response Rate;   Monitor for Minimal Residual Disease
9 Unknown  Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)
Conditions: Acute Myeloid Leukaemia;   Myelodysplasia
Intervention: Drug: Clofarabine
Outcome Measures: Treatment related mortality (TRM);   Overall survival (OS);   Event free survival (EFS);   Efficacy of Clofarabine as a leukaemia bulk-reducing agent prior to transplant conditioning;   Time to engraftment;   Donor/recipient chimerism;   Immune reconstitution parameters (T, B and NK cell subsets);   Duration of hospital stay;   Incidence of acute and chronic graft versus host disease;   Grade of acute and chronic graft versus host disease
10 Recruiting Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
Condition: Leukemia
Interventions: Drug: Decitabine;   Drug: Idarubicin;   Drug: Cytarabine;   Drug: Clofarabine
Outcome Measures: Maximum Tolerated Dose (MTD) of Clofarabine;   Response Rate
11 Recruiting Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Leukemia;   Lymphoma;   Allogeneic Haematopoietic Stem Cell Transplantation;   Acute Lymphoblastic Leukemia
Interventions: Drug: Busulfan;   Drug: Clofarabine;   Drug: Thymoglobulin;   Procedure: Stem Cell Transplant
Outcome Measure: Treatment-Related Mortality
12 Recruiting Allogeneic Stem Cell Transplant for Chronic Lymphocytic Leukemia (CLL)
Condition: Leukemia
Interventions: Drug: Busulfan;   Drug: Clofarabine;   Drug: Gemcitabine;   Drug: Thymoglobulin;   Procedure: Allogeneic Stem Cell Transplantation;   Drug: Filgrastim;   Drug: Tacrolimus;   Drug: Methotrexate
Outcome Measures: Maximum Tolerated Dose (MTD);   Success Rate
13 Recruiting Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant
Conditions: Adult Acute Megakaryoblastic Leukemia (M7);   Adult Acute Minimally Differentiated Myeloid Leukemia (M0);   Adult Acute Monoblastic Leukemia (M5a);   Adult Acute Monocytic Leukemia (M5b);   Adult Acute Myeloblastic Leukemia With Maturation (M2);   Adult Acute Myeloblastic Leukemia Without Maturation (M1);   Adult Acute Myeloid Leukemia in Remission;   Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;   Adult Acute Myeloid Leukemia With Del(5q);   Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);   Adult Acute Myeloid Leukemia With t(16;16)(p13;q22);   Adult Acute Myeloid Leukemia With t(8;21)(q22;q22);   Adult Acute Myelomonocytic Leukemia (M4);   Adult Erythroleukemia (M6a);   Adult Pure Erythroid Leukemia (M6b);   Childhood Acute Erythroleukemia (M6);   Childhood Acute Megakaryocytic Leukemia (M7);   Childhood Acute Minimally Differentiated Myeloid Leukemia (M0);   Childhood Acute Monoblastic Leukemia (M5a);   Childhood Acute Monocytic Leukemia (M5b);   Childhood Acute Myeloblastic Leukemia With Maturation (M2);   Childhood Acute Myeloblastic Leukemia Without Maturation (M1);   Childhood Acute Myeloid Leukemia in Remission;   Childhood Acute Myelomonocytic Leukemia (M4);   Recurrent Adult Acute Myeloid Leukemia;   Recurrent Childhood Acute Myeloid Leukemia
Interventions: Drug: clofarabine;   Radiation: total-body irradiation;   Drug: cyclosporine;   Drug: mycophenolate mofetil;   Procedure: peripheral blood stem cell transplantation;   Procedure: allogeneic hematopoietic stem cell transplantation;   Other: laboratory biomarker analysis;   Other: pharmacological study
Outcome Measures: Optimal dose of clofarabine in combination with 2, 3, or 4 Gy TBI in preparation for HCT from HLA-identical related and HLA-matched unrelated donors in patients with AML (Part 1);   Efficacy of the optimal dose of clofarabine combined with 2, 3, or 4 Gy TBI in reducing the relapse rate in patients with AML compared to our historical experience with fludarabine and 2, 3, or 4 Gy TBI (Part 2);   Leukemia-free survival;   NRM of less than 5%;   Engraftment rate of greater than or equal to 95%;   Minimal residual/recurring disease;   Pharmacokinetics of clofarabine;   Overall survival;   Prognostic cytogenetic and genetic markers (FLT3, RAS, nucleophosmin [NPM1], and C/EBP gene mutations)
14 Recruiting Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
Conditions: Stem Cell Transplantation;   Leukemia;   Lymphoma
Interventions: Drug: Thiotepa;   Drug: Clofarabine;   Drug: Busulfan;   Procedure: Allogeneic Stem Cell Transplantation;   Drug: Thymoglobulin (ATG);   Drug: G-CSF (Filgrastim)
Outcome Measure: Relapse-free Survival Rate
15 Unknown  Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma
Condition: B-Cell Lymphoma
Intervention: Drug: Clofarabine
Outcome Measures: tolerated dose (MTD) of clofarabine;   characterize and quantify the toxicity profile associated with clofarabine;   determine the overall response rate, plus partial response of clofarabine
16 Recruiting Sorafenib in Combination With Cytarabine and Clofarabine in Patients With Refractory or Relapsed Hematologic Malignancies
Conditions: Acute Myeloid Leukemia;   Infantile Leukemia (Both AML and ALL);   Myelodysplastic Syndrome;   Myelodysplastic/Myeloproliferative Neoplasms;   Biphenotypic Leukemia
Interventions: Drug: Sorafenib;   Drug: Cytarabine;   Drug: Clofarabine
Outcome Measure: To characterize a tolerable dose of sorafenib when given in combination with cytarabine and clofarabine in patients with relapsed/refractory hematologic malignancies.
17 Recruiting Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia or Acute Leukemia in Remission
Conditions: Adult Acute Lymphoblastic Leukemia in Remission;   Adult Acute Myeloid Leukemia in Remission;   Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;   Adult Acute Myeloid Leukemia With Del(5q);   Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);   Adult Acute Myeloid Leukemia With t(16;16)(p13;q22);   Adult Acute Myeloid Leukemia With t(8;21)(q22;q22);   de Novo Myelodysplastic Syndromes;   Previously Treated Myelodysplastic Syndromes;   Secondary Acute Myeloid Leukemia
Interventions: Drug: clofarabine;   Drug: melphalan;   Procedure: allogeneic hematopoietic stem cell transplantation;   Other: laboratory biomarker analysis;   Drug: tacrolimus;   Drug: sirolimus
Outcome Measures: Progression-free survival;   Overall survival;   Cumulative incidence of relapse/progression;   Cumulative incidence of non-relapse mortality defined as death occurring in a patient from causes other than relapse or progression;   Overall toxicity graded using the Bearman scale and CTCAE v4.0;   Incidence and severity of acute GVHD of grades 2-4 and 3-4 according to the consensus grading;   Incidence and severity of chronic GVHD scored according to National Institute of Health (NIH) consensus staging;   Microbiologically documented infection
18 Recruiting Dose Escalation of Clofarabine in Combination With Cytarabine and Idarubicin as Induction Therapy in High Risk AML
Condition: Acute Myeloid Leukemia
Intervention: Drug: clofarabine, cytarabine, idarubicin
Outcome Measures: maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin;   complete remission rate;   relapse-free, event-free and overall survival;   blast reduction in the bone marrow after the first induction cycle;   duration of aplasia;   therapy-associated morbidity and mortality;   course of molecular and cytogenetic markers during chemotherapy;   fraction of patients who receive an allogeneic stem cell transplantation in first complete remission
19 Recruiting Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia
Conditions: Acute Myeloid Leukemia;   Acute Lymphoblastic Leukemia
Interventions: Drug: Clofarabine;   Drug: Etoposide;   Drug: Cyclophosphamide;   Biological: allogeneic hematopoietic cell transplantation
Outcome Measures: Number of Patients Unable to Proceed to Transplantation;   Rate of Pre-Transplant Chemotherapy-Induced Aplasia;   Rate of Infectious Complications;   Treatment-Related Mortality After Transplant;   Disease-Free Survival After Transplant;   Rate of Leukemic Relapse After Transplant
20 Recruiting Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome;   Adult Acute Megakaryoblastic Leukemia (M7);   Adult Acute Minimally Differentiated Myeloid Leukemia (M0);   Adult Acute Monoblastic Leukemia (M5a);   Adult Acute Monocytic Leukemia (M5b);   Adult Acute Myeloblastic Leukemia With Maturation (M2);   Adult Acute Myeloblastic Leukemia Without Maturation (M1);   Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;   Adult Acute Myeloid Leukemia With Del(5q);   Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);   Adult Acute Myeloid Leukemia With t(16;16)(p13;q22);   Adult Acute Myeloid Leukemia With t(8;21)(q22;q22);   Adult Acute Myelomonocytic Leukemia (M4);   Adult Erythroleukemia (M6a);   Adult Pure Erythroid Leukemia (M6b);   Secondary Acute Myeloid Leukemia;   Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: clofarabine;   Drug: daunorubicin hydrochloride;   Other: clinical observation;   Drug: cytarabine;   Drug: decitabine;   Other: laboratory biomarker analysis;   Procedure: quality-of-life assessment;   Other: questionnaire administration
Outcome Measures: Overall survival;   Mortality rate;   Induction complete response rates;   Disease-free survival (DFS);   Epidemiological factors, measured using the Acute Leukemia Epidemiology and Survival in ECOG (ALESE) questionnaire;   Change in the Functional Assessment of Cancer Therapy (FACT)-Leukemia-specific (Leu) Trial Outcome Index (TOI) score;   Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score

These studies may lead to new treatments and are adding insight into Evoltra etiology and treatment.

A major focus of Evoltra research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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