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

Lymphoma Clinical Trial

Official title:

Transplantation Using Umbilical Cord And Placental Blood

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00008164
• Other study ID #: CDR0000068384
• Secondary ID: CPMC-IRB-7934CPM
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 6, 2001
• Last updated: December 17, 2013
• Start date: January 1997

Study information

• Verified date: January 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Langerhans Cell Histiocytosis
• Histiocytosis
• Histiocytosis, Langerhans-Cell
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia

Intervention

Procedure:
• umbilical cord blood transplantation

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 recip — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Toxicity			Yes
Primary	Survival			No
Primary	Incidence of graft-versus-host disease			No