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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008164
  Purpose

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.


Condition Intervention Phase
Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Procedure: umbilical cord blood transplantation
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Anemia    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Transplantation Using Umbilical Cord And Placental Blood

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   30
Study Start Date:   January 1997

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.

  Eligibility
Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008164

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University    
      New York, New York, United States, 10032

Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     David G. Savage, MD     Herbert Irving Comprehensive Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068384, CPMC-IRB-7934, CPMC-CAMP-021, NCI-G00-1899
First Received:   January 6, 2001
Last Updated:   December 25, 2007
ClinicalTrials.gov Identifier:   NCT00008164
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
refractory plasma cell neoplasm  
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  
Langerhans cell histiocytosis  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
recurrent/refractory childhood Hodgkin lymphoma
stage I adult Burkitt lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Langerhans cell histiocytosis
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Mycoses
Letterer-Siwe disease
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Lung Diseases, Interstitial
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Acute myelogenous leukemia
Myeloproliferative Disorders
Leukemia, Myeloid
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Reticuloendotheliosis
Immune System Diseases
Blood Protein Disorders
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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