Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
Official Title
Transplantation Using Umbilical Cord And Placental Blood
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Jan 2007
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Active, not recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 1997
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jan 6, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 17, 2013
Last Update Posted Date
Dec 18, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Herbert Irving Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.
Detailed Description
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.
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.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 4-5 years.
Conditions Module
Conditions
Childhood Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Keywords
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
childhood Langerhans cell histiocytosis
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
30Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
umbilical cord blood transplantation
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Response rate
Toxicity
Survival
Incidence of graft-versus-host disease
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
60 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
David G. Savage, MD
Herbert Irving Comprehensive Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Herbert Irving Comprehensive Cancer Center at Columbia University