Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia - Tabular View

Tracking Information

First Received Date ^ICMJE

January 6, 2001

Last Updated Date

April 26, 2009

Start Date ^ICMJE

January 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Response rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Survival [ Designated as safety issue: No ]
Incidence of graft-versus-host disease [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Response rate
Toxicity
Survival
Incidence of graft-versus-host disease

Change History

Complete list of historical versions of study NCT00008164 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia

Official Title ^ICMJE

Transplantation Using Umbilical Cord And Placental Blood

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Childhood Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

Procedure: umbilical cord blood transplantation

Study Arms / Comparison Groups

Publications *

Styczynski J, Cheung YK, Garvin J, Savage DG, Billote GB, Harrison L, Skerrett D, Wolownik K, Wischhover C, Hawks R, Bradley MB, Del Toro G, George D, Yamashiro D, van de Ven C, Cairo MS. Outcomes of unrelated cord blood transplantation in pediatric recipients. Bone Marrow Transplant. 2004 Jul;34(2):129-36.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00008164

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068384, CPMC-IRB-7934, CPMC-CAMP-021, NCI-G00-1899

Study Sponsor ^ICMJE

Herbert Irving Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

David G. Savage, MD

Herbert Irving Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP