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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.
First Received: January 6, 2001   Last Updated: April 26, 2009   History of Changes
Sponsor: Herbert Irving Comprehensive Cancer Center
Collaborator: 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
Childhood Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
 Procedure: umbilical cord blood transplantation
 Phase II

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

Resource links provided by NLM:

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

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

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

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.

Study ID Numbers: CDR0000068384, CPMC-IRB-7934, CPMC-CAMP-021, NCI-G00-1899
Study First Received: January 6, 2001
Last Updated: April 26, 2009
ClinicalTrials.gov Identifier: NCT00008164     History of Changes
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 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
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

Additional relevant MeSH terms:
Precancerous Conditions
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Leukemia
Preleukemia
Pathologic Processes
Hemorrhagic Disorders
Histiocytosis
Respiratory Tract Diseases
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Lung Diseases, Interstitial
 Disease
Reticuloendotheliosis
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Histiocytosis, Langerhans-Cell
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Lung Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 27, 2009



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