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

December 17, 2013 updated by: Herbert Irving Comprehensive Cancer Center

Transplantation Using Umbilical Cord And Placental Blood

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David G. Savage, MD, Herbert Irving Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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