Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Muscle Weakness

Paresis

Asthenia

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Mycophenolic Acid

Azathioprine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Enzyme Inhibitors

MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily

AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily

Mycophenolic acid

1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily

Jiann-Horng Yeh, M.D.

This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.

This will be a double-dummy study to keep the blinded quality.

* MA group: 1 tablet AZA placebo and 4 tables MA (180 mg/tab,720 mg/day) twice daily.
* AZA group: 1 tablet AZA (50mg/tab) and 4 tables MA placebo twice daily.

  * When patients achieve minimal manifestation (MM, i.e. complete remission), which lead to normal daily routine, the dose of pyridostigmine should reduce to 240 mg/day (4 tablets) or less. The dose of steroid should be stepped down by 10 mg qod (every other day) for every 2 weeks until the dose achieves 40 mg qod. After that, the dose should be stepped down by 5 mg qod for every month.
  * When disease progresses and is no longer maintaining minimal manifestation, the dose of steroid will be stepped up by 10 mg qod for every 2 weeks until achieve clinical stable remission. The taper rule of steroid could start again 1 month after stabilization.
  * Every patient will be treated for 1 year. If the patient could not achieve MM within 1 year, the blind of individual patient will be opened and the patients will be crossed over to another medical treatment. The efficacy and safety of second medication will be observed openly until the end of study.
  * When the muscle weakness worsens under established study schedule, plasmapheresis could be conducted to improve the condition rapidly.

Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

Qualitix Clinical Research Co., Ltd.

Jiann-Horng Yeh / M.D.

Blood and Lymph Conditions

Lymphoma

Leukemia

Hodgkin Disease

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Lymphosarcoma

Hodgkin Lymphoma

Fludarabine

Fludarabine phosphate

Jeannine S McCune, PharmD

We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.

Blood Samples to Evaluate Biomarkers of Donor Chimerism

National Heart, Lung, and Blood Institute (NHLBI)

Fred Hutchinson Cancer Center

Jeannine S. McCune, PharmD

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Cyclophosphamide

Jeannine McCune, PharmD

The investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. We will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.

Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis	NCT00997412	Myasthenia Grav...	Mycophenolic ac... AZA	20 Years - 70 Years	Qualitix Clinical Research Co., Ltd.
Blood Samples to Evaluate Biomarkers of Donor Chimerism	NCT00764829	Leukemia Hodgkins Diseas... Non-hodgkins Ly... Myelodysplastic...		18 Years -	Fred Hutchinson Cancer Center
Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients	NCT01141959	Leukemia Hodgkin Disease Non-Hodgkin Lym... Myelodysplastic... Multiple Myelom...		18 Years -	Fred Hutchinson Cancer Center
Blood Samples to Evaluate Biomarkers of Donor Chimerism	NCT00764829	Leukemia Hodgkins Diseas... Non-hodgkins Ly... Myelodysplastic...		18 Years -	Fred Hutchinson Cancer Center
Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients	NCT01141959	Leukemia Hodgkin Disease Non-Hodgkin Lym... Myelodysplastic... Multiple Myelom...		18 Years -	Fred Hutchinson Cancer Center

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