Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information
Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | Under physiologic 60 | NCI | CPMC-IRB-7934 CPMC-CAMP-021, NCI-G00-1899, NCT00008164 |
Objectives
- Determine the response rate of patients with chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder treated with allogeneic umbilical cord and placental blood transplantation.
- Determine the toxicity of this regimen in these patients.
- Determine survival in these patients treated with this regimen.
- Determine the incidence of graft-versus-host disease in these patients treated with this regimen.
Entry Criteria
Disease Characteristics:
- Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder
- Eligible for allogeneic bone marrow transplantation, but lacking a donor
- Available donor umbilical cord blood that is mismatched on no more than
2 HLA
loci
- HIV negative
- Hepatitis B surface antigen and hepatitis C negative
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age:
- Under physiologic 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2 times normal
- No severe hepatic disease
- Hepatitis B surface antigen and hepatitis C negative
Renal:
- Creatinine less than 2 times normal
Other:
- HIV negative
- Not pregnant or nursing
- No other serious medical or psychiatric illness that would preclude study compliance
- No serious infection
Expected Enrollment
30A total of 30 patients will be accrued for this study within 4-5 years.
Outcomes
Primary Outcome(s)Response rate
Toxicity
Survival
Incidence of graft-versus-host disease
Outline
Patients receive a standard preparative regimen for their disease. Following the preparative regimen patients undergo umbilical cord blood stem cell transplantation on day 0.
Patients are followed every 1-2 weeks for 6 months.
Published ResultsStyczynski J, Cheung YK, Garvin J, et al.: Outcomes of unrelated cord blood transplantation in pediatric recipients. Bone Marrow Transplant 34 (2): 129-36, 2004.[PUBMED Abstract]
Trial Lead Organizations
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 | | | |
| David Savage, MD, Protocol chair | |
| |
| |||
| Registry Information | ||
| ||
| Official Title | Transplantation Using Umbilical Cord And Placental Blood | |
| ||
| Trial Start Date | 1997-01-29 | |
| ||
| Registered in ClinicalTrials.gov | NCT00008164 | |
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| Date Submitted to PDQ | 2000-11-16 | |
| ||
| Information Last Verified | 2007-01-15 | |
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| NCI Grant/Contract Number | CA13696 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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