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

NCT ID: NCT00008164

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

umbilical cord blood transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

David G. Savage, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

References

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. doi: 10.1038/sj.bmt.1704537.

Reference Type: RESULT

PMID: 15107815 (View on PubMed)

Other Identifiers

CPMC-IRB-7934

Identifier Type: -

Identifier Source: secondary_id

CPMC-CAMP-021

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1899

Identifier Type: -

Identifier Source: secondary_id

CDR0000068384

Identifier Type: -

Identifier Source: org_study_id