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Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia Clinical research trials and Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia. Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia clinical trial. Human subjects often receive the most effective healthcare possible for their Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "U" Clinical Trials Conditions > Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia  Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
For Condition: Myelodysplastic Syndromes,atypical chronic myeloid leukemia,myelodysplastic and myeloproliferative disease
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation in treating patients who have severe aplastic anemia, malignantthymoma, or myelodysplasia.
Details: OBJECTIVES: - Determine the rates of durable engraftment in patients with severe aplastic anemia, myelodysplastic syndrome, inborn errors of metabolism, or inherited hematopoietic disorders, refractory to medical management, who are undergoing high-dose chemoradiotherapy followed by unrelated cord blood (UCB) transplantation. - Evaluate the rate and quality of immunologic reconstitution in this patient population. OUTLINE: Patients are stratified according to weight (under 45 kg vs over 45 kg). Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT). The regimen varies according to the underlying cause of the anemia, but could include busulfan, cyclophosphamide or melphalan, anti-thymocyte globulin or methylprednisolone, and/or radiation therapy. One day after the conditioning regimen is completed, patients receive the UCBT. Patients are followed weekly for 3 months, at 6 months, then every 6 months for 2.5 years, then annually thereafter. PROJECTED ACCRUAL: A total of 4-90 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of severe aplastic anemia based on bone marrow cellularity of less than 20% - Must meet at least two of the following criteria: - Granulocyte count less than 500/mm^3 - Platelet count less than 20,000/mm^3 - Reticulocyte count less than 50,000/mm^3 - Following etiologies eligible: - Fanconi's anemia - Hypoplastic leukemia - Monosomy 7 - Drug exposure (chloramphenicol, NSAIDS) - Viral exposure (EBV, hepatitis, parvovirus, HIV) - Nutritional deficiencies - Thymoma - Paroxysmal nocturnal hemoglobinuria - Amegakaryocytic thrombocytopenia OR - Histologically confirmed myelodysplastic syndrome (MDS) that is refractory to medical management or with cytogenic abnormalities predictive of transformation into acute leukemia, including 5q-, 7q-, monosomy 7, or trisomy 8 - The following etiologies only are eligible: - Refractory anemia - Refractory anemia with ringed sideroblasts - De novo primary MDS - Therapy-related secondary MDS OR - Confirmed diagnosis of inherited hematopoietic disorder that is refractory to medical management - Following etiologies eligible: - Severe combined immunodeficiency - Familial erythrophagocytic lymphohistiocytosis - Wiskott-Aldrich syndrome - Kostmann's syndrome (infantile histiocytosis) - Chronic granulomatous disease - Leukocytic adhesion deficiency - Chediak-Higashi syndrome - Paroxysmal nocturnal hemoglobinuria - Fanconi's anemia - Dyskeratosis congenita - Diamond-Blackfan anemia - Amegakaryocytic thrombocytopenia - Osteopetrosis - Gaucher's disease - Lesch-Nyhan syndrome - Mucopolysaccharidoses - Lipodoses - Autologous or haploidentical related peripheral blood stem cells available as backup - Serologically matched umbilical cord blood unit available in the New York Blood Center's Placental Blood Project, or other acceptable umbilical cord blood registry PATIENT CHARACTERISTICS: Age: - 55 and under Performance status: - Zubrod 0-1 - Karnofsky 80-100% Life expectancy: - At least 3 months Hematopoietic: - See Disease Characteristics Hepatic: - ALT/AST no greater than 4 times normal - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 50 mL/min Cardiovascular: - Normal cardiac function by echocardiogram or radionuclide scan - Shortening fraction or ejection fraction at least 80% normal for age - Non-Fanconi patients with acquired or congenital cardiomyopathy may receive melphalan as a substitute for cyclophosphamide Pulmonary: - FVC and FEV_1 at least 60% of predicted for age - DLCO at least 60% of predicted in adult patients Other: - No active concurrent malignancy - No active infection - Not pregnant or nursing - HIV negative - Must have an available serologic matched Umbilical Cord Blood Unit (UCBU) in the New York Blood Center's Placental Blood Project, or other acceptable Umbilical Cord Blood (UCB) registry PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent cytotoxic chemotherapy Endocrine therapy: - No concurrent immunosuppressive medications Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryLaughlin, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Mary Laughlin 216-844-8609
Additional Information:
Study ID Numbers: CDR0000066307; CWRU-5Y97,NCI-G98-1431
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003336
Other Atypical Chronic Myeloid Leukemia Studies:
1. Experimental Bone Marrow Transplant Protocol
2. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
3. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
4. Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
5. A Randomized Trial of Recombinant Humanized Anti-IL-2 Receptor Antibody (Daclizumab) Versus Antithymocyte Globulin (ATG) to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)
Related Studies:
Other atypical chronic myeloid leukemia Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
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