Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00054236|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : September 12, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: anti-thymocyte globulin Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: umbilical cord blood transplantation Drug: methylprednisolone||Phase 1|
- Determine the incidence and severity of acute toxicity in patients with hematologic malignancies or severe aplastic anemia treated with a non-myeloablative conditioning regimen followed by umbilical cord blood transplantation.
- Determine the incidence and severity of acute and chronic graft-versus-host-disease in patients treated with this regimen.
- Determine the incidence of relapse, disease-free survival, and overall survival of patients treated with this regimen.
- Determine the survival rate at 100 days post-transplantation in patients treated with this regimen.
- Determine the incidence of regimen-related complications (infection, hepatic veno-occlusive disease, and interstitial pneumonitis) in patients treated with this regimen.
- Determine the incidence of primary and secondary graft failure in patients treated with this regimen.
- Determine the rates and kinetics of donor-derived lymphoid, myeloid, neutrophil, RBC, and platelet engraftment in patients treated with this regimen.
OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
|Experimental: non-myeloablative conditioning regimen||
Biological: anti-thymocyte globulin
anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1Biological: filgrastim
Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.Drug: cyclophosphamide
cyclophosphamide IV over 2 hours on days -3 to -2Drug: fludarabine phosphate
fludarabine IV over 30 minutes on days -8 to -4Procedure: umbilical cord blood transplantation
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1.Drug: methylprednisolone
Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
- Event-free survival by disease assessment [ Time Frame: at 28 and 100 days and then at 6, 9, 12, 18, and 24 months ]
- Umbilical cord blood donor engraftment by chimerism and complete blood count (CBC) [ Time Frame: monthly for 6 months and then at 9, 12, 18, and 24 months ]
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): NCT00054236
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Brenda Cooper, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|