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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070135 |
Purpose
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer 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 cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by a donor stem cell transplant works in treating older patients with acute myeloid leukemia that is in the first complete remission.
| Condition | Intervention | Phase |
|
Leukemia |
Drug: busulfan Drug: filgrastim Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Filgrastim Methotrexate Fludarabine Fludarabine monophosphate Tacrolimus Tacrolimus anhydrous Busulfan |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen |
| Estimated Enrollment: | 61 |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 60 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) in first morphologic complete remission
Morphologic complete remission achieved within the past 6 months and after no more than 2 courses of induction chemotherapy
Complete morphologic remission is defined by all of the following criteria:
No more than 2 courses of prior consolidation therapy
The following donors will be allowed:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin less than 2 mg/dL*
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, California | |||||
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | ||||
| San Francisco, California, United States, 94115 | |||||
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |||||
| United States, Delaware | |||||
| CCOP - Christiana Care Health Services | Recruiting | ||||
| Newark, Delaware, United States, 19713 | |||||
| Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 | |||||
| Tunnell Cancer Center at Beebe Medical Center | Recruiting | ||||
| Lewes, Delaware, United States, 19958 | |||||
| Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |||||
| United States, Maryland | |||||
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting | ||||
| Baltimore, Maryland, United States, 21201 | |||||
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |||||
| Union Hospital Cancer Program at Union Hospital | Recruiting | ||||
| Elkton MD, Maryland, United States, 21921 | |||||
| Contact: Frank Beardell, MD 302-737-7700 | |||||
| United States, Massachusetts | |||||
| Dana-Farber/Brigham and Women's Cancer Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Contact: Clinical Trials Office 617-724-5200 | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center 617-582-8480 | |||||
| Massachusetts General Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |||||
| United States, Minnesota | |||||
| Masonic Cancer Center at University of Minnesota | Recruiting | ||||
| Minneapolis, Minnesota, United States, 55455 | |||||
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |||||
| United States, Missouri | |||||
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting | ||||
| Saint Louis, Missouri, United States, 63110 | |||||
| Contact: Ravi Vij, MD 314-454-8323 | |||||
| United States, New Jersey | |||||
| Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting | ||||
| Voorhees, New Jersey, United States, 08043 | |||||
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |||||
| United States, New York | |||||
| CCOP - North Shore University Hospital | Recruiting | ||||
| Manhasset, New York, United States, 11030 | |||||
| Contact: Ruthee-Lu Bayer, MD 516-562-8973 | |||||
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting | ||||
| Manhasset, New York, United States, 11030 | |||||
| Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |||||
| Long Island Jewish Medical Center | Recruiting | ||||
| New Hyde Park, New York, United States, 11042 | |||||
| Contact: Ruthee-Lu Bayer, MD 516-562-8973 | |||||
| Roswell Park Cancer Institute | Recruiting | ||||
| Buffalo, New York, United States, 14263-0001 | |||||
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |||||
| United States, North Carolina | |||||
| Wake Forest University Comprehensive Cancer Center | Recruiting | ||||
| Winston-Salem, North Carolina, United States, 27157-1096 | |||||
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |||||
| United States, Ohio | |||||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting | ||||
| Columbus, Ohio, United States, 43210-1240 | |||||
| Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center - Philadelphia | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19111-2497 | |||||
| Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |||||
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |||||
| Contact: John Lister 412-578-5000 | |||||
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Steven M. Devine, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000330001, CALGB-100103 |
| First Received: | October 3, 2003 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00070135 |
| Health Authority: | Unspecified |
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