Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00004114|
Recruitment Status : Withdrawn (Study never opened)
First Posted : February 16, 2004
Last Update Posted : October 2, 2015
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 used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Myelodysplastic Syndromes||Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation||Phase 1|
OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative, fludarabine based conditioning regimen in patients with advanced hematologic malignancies. II. Determine the toxicities of this regimen, especially graft versus host disease, in these patients.
OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4, cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004114
|Study Chair:||Christos E. Emmanouilides, MD||Jonsson Comprehensive Cancer Center|