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Phase II Study of Allogeneic Umbilical Cord and Placental Blood Transplantation in Patients With Chronic Myeloid Leukemia, Acute Leukemia, Lymphoma, Myeloma, Myelodysplasia, Aplastic Anemia, Fanconi's Anemia, Histiocytosis, Hereditary Immunodeficiency, or Storage Disorder

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed Under physiologic 60 NCI CPMC-IRB-7934
CPMC-CAMP-021, NCI-G00-1899, NCT00008164

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

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

Expected Enrollment

A total of 30 patients will be accrued for this study within 4-5 years.

Outcomes

Primary Outcome(s)

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

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.

Published Results

Styczynski J, Cheung YK, Garvin J, et al.: Outcomes of unrelated cord blood transplantation in pediatric recipients. Bone Marrow Transplant 34 (2): 129-36, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

David Savage, MD, Protocol chair
Ph: 212-305-9783

Registry Information

Official Title		Transplantation Using Umbilical Cord And Placental Blood

Trial Start Date		1997-01-29

Registered in ClinicalTrials.gov		NCT00008164

Date Submitted to PDQ		2000-11-16

Information Last Verified		2007-01-15

NCI Grant/Contract Number		CA13696

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.