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Clinical Trials for Leukemia

General Purpose:

If you are one of the 47,000 individuals who will be diagnosed with leukemia in the United States in 2012, you may be presented with one of many possible treatment options. Depending on the type of leukemia you have, treatments can include watchful waiting (i.e., no immediate treatment), chemotherapy, targeted therapies that attack specific cancer cells, biological therapies to boost your immune system, radiation therapy, and/or bone marrow transplantation.

In addition, researchers all across the United States are investigating new and better methods of treating leukemia, including treatments that result in fewer side effects and improve overall quality of life.

What Will Clinical Trials for Leukemia Be Like?

Clinical trials for leukemia will likely involve frequent blood testing to evaluate your blood cell count, in particular your white blood cells and platelets. Leukemia results in an Clinical Trials for Leukemiaexceptionally high number of white blood cells and can lower platelet counts substantially. White blood cells form the basis of the body’s immune system and are its primary line of defense against infection.

Platelets are necessary to help blood to clot and prevent excessive bleeding. In addition to frequent blood tests, you may also undergo frequent biopsies of your bone marrow, which is the only way to know for certain if leukemia cells are still present.

In addition to frequent blood tests and biopsies, other tests and procedures that may be performed in clinical trials for leukemia for leukemia include:

  • Chromosome analysis of blood and tissue samples to determine the presence of abnormal chromosomes.
  • Spinal tap, which is a procedure that involves removing a sample of the fluid surrounding your spinal cord.
  • Chest x-ray
  • Pain assessments
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.

Typical Protocol for Clinical Trials for Leukemia:

There is an abundance of research investigating new treatment options for leukemia, as well as studies that are seeking to find better ways to minimize the side effects of treatment.

Research is also working to identify certain genetic characteristics that can indicate how a person will respond to treatment, as well as which treatment is the most appropriate. Possible examples of clinical trials for leukemia include the following:

  • A clinical trial that evaluates the effectiveness of a treatment designed to keep a protein that is very active in leukemia from functioning.
  • A clinical trial that investigates the effectiveness of a new combination of chemotherapy drugs compared to standard chemotherapy for leukemia, and which also compares the side effects of both treatment approaches.
  • A clinical trial designed to better determine the best timing for the use of stem cell transplants during a standard course of treatment for leukemia.
  • A study designed to evaluate the effectiveness of a vaccine (developed using an individual’s own white blood cells) that targets and attacks specific protein on leukemia cells.
  • A study designed to evaluate new medications for boosting the immune system while undergoing standard treatment for leukemia, in order to reduce the rate of infection.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” Clinical Trials for Leukemiatreatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

Clinical Trials for LeukemiaThe type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The specific type of leukemia you have: chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), acute lymphocytic (or lymphoblastic) leukemia (ALL), or acute myeloid leukemia (AML). Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms:

Once you are ready to begin your search for leukemia clinical trials, the following search terms may be of use when combined with the specific type of leukemia you have: “leukemia treatment,” “vaccine,” “infection,” “fatigue,” “leukemia children,” “pediatric,” “remission,” and “relapse.” 

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A Phase 1 Study of CD22 CAR T-Cell Immunotherapy for CD22+ Leukemia

Condition:   Leukemia
Intervention:   Biological: Patient-derived CD22-specific CAR T-cells also expressing an EGFRt
Sponsor:   Seattle Children's Hospital

A Pilot Study of a Personalized Neoantigen Cancer Vaccine With and Without Low-Dose Cyclophosphamide in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated Chronic Lymphocytic Leukemia.

Condition:   Lymphocytic Leukemia
Interventions:   Drug: NeoVax;   Drug: Cyclophosphamide
Sponsors:   Dana-Farber Cancer Institute;   Oncovir, Inc.;   Neon Therapeutics, Inc.
Not yet recruiting

Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia

Condition:   Acute Myeloid Leukemia
Intervention:   Drug: OPB-111077
Sponsors:   Hospital Universitario 12 de Octubre;   Otsuka Pharmaceutical Co., Ltd.;   Apices Soluciones S.L.

Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

Condition:   Acute Myeloid Leukemia (AML)
Sponsor:   Technische Universität Dresden

Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia

Conditions:   Acute Myeloid Leukemia;   Relapse Leukemia
Interventions:   Drug: Cladribine;   Drug: G-CSF;   Drug: Aclarubicin;   Drug: Cytarabine
Sponsor:   Sun Yat-sen University

Alternative Splicing and Leukemia Initiating Cells

Condition:   Acute Myeloid Leukemia
Intervention:   Other: Assessment of splicing variants
Sponsor:   Hospices Civils de Lyon

Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

Condition:   Acute Promyelocytic Leukemia
Intervention:   Other: QoL questionnaires
Sponsor:   Gruppo Italiano Malattie EMatologiche dell'Adulto

A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

Condition:   Acute Myeloid Leukemia
Interventions:   Other: Standard Leukemia Care;   Other: Palliative Care
Sponsors:   Massachusetts General Hospital;   Duke University

Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia

Condition:   Leukemia
Intervention:   Biological: CD19-targeted CAR-T cells
Sponsors:   Sinobioway Cell Therapy Co., Ltd.;   The Second Hospital of Anhui Medical University

Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

Condition:   Acute Promyelocytic Leukemia
Interventions:   Drug: Arsenic trioxide;   Drug: Idarubicin;   Drug: Cytarabine;   Drug: Tretinoin;   Drug: Mitoxantrone;   Drug: Mercaptopurine;   Drug: Methotrexate
Sponsors:   Technische Universität Dresden;   Gruppo Italiano Malattie EMatologiche dell'Adulto;   Groupe Francophone des Myelodysplasies;   Haemato Oncology Foundation for Adults in the Netherlands;   Programa para el Tratamiento de Hemopatías Malignas;   German Federal Ministry of Education and Research;   Teva Pharmaceuticals Europe

A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Condition:   Chronic Lymphocytic Leukemia
Interventions:   Drug: Obinutuzumab;   Drug: Ibrutinib
Sponsors:   Dana-Farber Cancer Institute;   Genentech, Inc.

Monitoring and Treatment of Relapsed Leukemia Following Allogeneic Hematopoietic Stem Cell Transplantation in Children

Condition:   Leukemia
Interventions:   Drug: Bortezomib;   Drug: Pravastatin
Sponsors:   Reuven Schore;   Millennium Pharmaceuticals, Inc.;   Hyundai Hope On Wheels

Phase I Dose Escalation of BAY1143572 in Subjects With Acute Leukemia

Condition:   Leukemia
Intervention:   Drug: BAY1143572
Sponsor:   Bayer

Impact of a Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL) by Maintaining a Database

Condition:   Leukemia, Promyelocytic, Acute
Sponsors:   Emory University;   The Leukemia and Lymphoma Society
Active, not recruiting

A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

Conditions:   Chronic Lymphocytic Leukemia;   Leukemia
Interventions:   Drug: Ibrutinib;   Drug: Fludarabine;   Drug: Cyclophosphamide;   Drug: Rituximab
Sponsors:   Dana-Farber Cancer Institute;   Pharmacyclics LLC.

Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy Water Labeling in Subjects With CLL and SLL

Condition:   Leukemia
Interventions:   Other: Heavy Water (2H2O);   Drug: PCI-32765
Sponsors:   M.D. Anderson Cancer Center;   Pharmacyclics LLC.
Active, not recruiting

Acute Promyelocytic Leukemia (APL) Treated With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin

Condition:   Leukemia
Interventions:   Drug: ATRA;   Drug: ATO;   Drug: GO (Gemtuzumab ozogamicin);   Drug: Methylprednisolone
Sponsors:   M.D. Anderson Cancer Center;   Pfizer

Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

Condition:   Leukemia
Interventions:   Genetic: DNA analysis;   Genetic: fluorescence in situ hybridization;   Genetic: gene expression analysis;   Genetic: microarray analysis;   Genetic: mutation analysis;   Genetic: polymerase chain reaction;   Other: laboratory biomarker analysis
Sponsors:   Alliance for Clinical Trials in Oncology;   National Cancer Institute (NCI)
Active, not recruiting

Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia

Condition:   Leukemia
Interventions:   Genetic: fluorescence in situ hybridization;   Genetic: mutation analysis;   Genetic: nucleic acid sequencing;   Genetic: polymerase chain reaction;   Genetic: western blotting;   Other: flow cytometry;   Other: laboratory biomarker analysis
Sponsors:   Alliance for Clinical Trials in Oncology;   National Cancer Institute (NCI)
Active, not recruiting

Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

Condition:   Leukemia
Interventions:   Genetic: microarray analysis;   Genetic: reverse transcriptase-polymerase chain reaction;   Other: flow cytometry
Sponsors:   ECOG-ACRIN Cancer Research Group;   National Cancer Institute (NCI)

JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia

Condition:   Leukemia
Intervention:   Drug: JVRS-100
Sponsor:   Milton S. Hershey Medical Center
Active, not recruiting

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Condition:   Leukemia
Intervention:   Drug: Dasatinib
Sponsor:   Bristol-Myers Squibb
Active, not recruiting

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Condition:   Leukemia
Interventions:   Drug: arsenic trioxide;   Drug: gemtuzumab ozogamicin;   Drug: mercaptopurine;   Drug: methotrexate;   Drug: tretinoin
Sponsors:   Southwest Oncology Group;   National Cancer Institute (NCI)

Phase III Trial in Acute Promyelocytic Leukemia Patients

Condition:   Leukemia
Interventions:   Drug: arsenic trioxide;   Drug: idarubicin;   Drug: mercaptopurine;   Drug: methotrexate;   Drug: all-trans retinoic acid;   Drug: all-trans retinoic acid (ATRA)
Sponsors:   Gruppo Italiano Malattie EMatologiche dell'Adulto;   Study Alliance Leukemia (SAL) Group
Active, not recruiting

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Condition:   Leukemia
Intervention:   Drug: Dasatinib
Sponsors:   Bristol-Myers Squibb;   Innovative Therapies For Children with Cancer Consortium
Active, not recruiting

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