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| Tracking Information | |||||
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| First Received Date ICMJE | March 6, 2003 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | December 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00055744 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chemotherapy, Stem Cell Transplantation, and Graft-Versus-Host-Disease Prevention in Treating Patients With Refractory or Relapsed Hematologic Cancer, Myelodysplastic Syndrome, or Myeloproliferative Disorder | ||||
| Official Title ICMJE | A Pilot Study of EPOCH-F/R Induction Chemotherapy and Reduced-Intensity, HLA-Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation for Refractory or Relapsed Hematologic Malignancies, With Cyclosporine & Methotrexate for Graft-Versus-Host Disease Prophylaxis | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and methotrexate may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combining cyclosporine with methotrexate in preventing graft-versus-host disease following chemotherapy and allogeneic stem cell transplantation in patients who have refractory or relapsed hematologic cancer, myelodysplastic syndrome, or myeloproliferative disorder. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a pilot study.
Patients with persistent or progressive disease after ASCT or mixed chimerism that does not improve after tapering or discontinuing immune suppression may receive donor lymphocyte infusions. Patients are followed twice weekly for 3 months, monthly for 3 months, every 3 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 8-40 patients will be accrued for this study within 2 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
OR
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00055744 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000271137, NCI-03-C-0077 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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