DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aplastic Anemia

Intervention: cyclophosphamide (Drug); anti-thymocyte globulin (Biological); cyclosporine (Drug); allogeneic bone marrow transplantation (Procedure); methotrexate (Drug); DNA analysis (Genetic); flow cytometry (Other); polymorphism analysis (Genetic); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Official(s) and/or principal investigator(s):
Rainer Storb, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Summary

This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host disease (GVHD) in patients with severe aplastic anemia undergoing donor bone marrow transplant. Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before and methotrexate and cyclosporine after transplant may stop this from happening

Clinical Details

Official title: Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of chronic GVHD

Secondary outcome:

Engraftment

Overall survival

Detailed description: PRIMARY OBJECTIVES: I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 2. 0-2. 5 x 10^8 nucleated cells/kg. SECONDARY OBJECTIVES: I. Engraftment and overall survival. OUTLINE:

CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days - 5 to -2

and anti-thymocyte globulin IV over 4-10 hours on days - 4 to -2.

TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine

IV over 1 hour or orally (PO) twice daily on days - 1 to 50, followed by a taper until 6

months after grafting. After completion of study treatment, patients are followed up at on day 180, 1 year, 1. 5 years, 2 years, 3 years, and yearly thereafter.

Eligibility

Minimum age: N/A. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Any patient who has aplastic anemia with marrow failure involving 2 of the three

following criteria: granulocytes < 500/uL; a corrected reticulocyte count of < 1%; platelet count of < 20,000/uL

- Availability of an human leukocyte antigen (HLA)-matched family member

- DONOR: Family member who is HLA-matched

- DONOR: If more than one HLA-matched family member is available, priority will be

given to a donor who is genotypically HLA-identical, of appropriate cytomegalovirus (CMV) serology, ABO compatible, and, in case of a female donor, non-parous Exclusion Criteria:

- Severe disease other than aplastic anemia that would severely limit the probability

of survival during the graft procedure:

- Patients who have developed clonal cytogenetic abnormalities or myelodysplastic

syndrome (preleukemia)

- Patients with Fanconi's anemia

- Aplasia secondary to radiation or cytotoxic chemotherapy

- Patients with paroxysmal nocturnal hemoglobinuria who have not developed

aplastic anemia

- Severe organ toxicities:

- Cardiac insufficiency requiring treatment or symptomatic coronary artery

disease;

- Severe hypoxemia , partial pressure of oxygen (pO2) < 70 mm Hg, with decreased

diffusion capacity of carbon monoxide (DLCO) < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted;

- Impaired renal function (creatinine > 2 times upper limit of normal or estimated

creatinine clearance < 60 ml/min)

- Fungal infections with radiological progression after receipt of amphotericin B or

active triazole for greater than 1 month

- Human immunodeficiency virus (HIV)-positive patients

- Females who are pregnant or breast-feeding

- DONOR: Donors who have increase anesthetic risk and are not able psychologically and

medically to tolerate the procedure

- DONOR: HIV-positive donors

Locations and Contacts

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah 84112, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: February 2006
Last updated: September 18, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017