Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

Cancer Clinical Trial

Official title:

Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003538
• Other study ID #: CDR0000066589, J9711
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: May 1, 2014
• Start date: March 1997
• Est. completion date: May 2004

Study information

• Verified date: May 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Stem cells that have been treated in the laboratory to remove lymphocytes may prevent this from happening.

PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone marrow transplantation.

Description:

OBJECTIVES:

• Determine whether stem cell augmented, elutriated grafts prevent graft versus host disease in patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients receive elutriated CD34+ augmented donor bone marrow on day 0.

Bone marrow samples are obtained before day 100, around 6 months, and 1 year after transplant.

PROJECTED ACCRUAL: Not specified

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of one the following:

• Acute myelogenous leukemia in CR1, ER1, CR2, ER2, CR3

• Acute lymphocytic leukemia in CR1, ER1, CR2, ER2, CR3

• Non-Hodgkin's lymphoma

• Hodgkin's lymphoma

• Multiple myeloma with no more than 12 months of prior alkylator based chemotherapy

• Myelodysplastic syndrome (MDS)

• Acute leukemia arising out of MDS

• Primary resistant acute leukemia

• Chronic myelomonocytic leukemia

• Aplastic anemia (40 years of age and over)

• Solid tumor malignancy (germ cell, sarcoma, breast, etc.)

• Genetic disorders or inborn errors of metabolism as defined by preparative regimen protocol

• Chronic myelogenous leukemia

• Must meet all inclusion criteria specified by the respective preparative regimen protocol

• No aplastic anemia under 40 years of age or myelofibrosis

PATIENT CHARACTERISTICS:

Age:

• 0.5 to 65

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior red blood cell or platelet transfusions from a sibling donor

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Graft vs Host Disease

Intervention

Biological:
• graft versus host disease prophylaxis/therapy

Procedure:
• allogeneic bone marrow transplantation

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

O'Donnell PV, Jones RJ, Vogelsang GB, Seber A, Ambinder RF, Flinn I, Miller C, Marcellus DC, Griffin C, Abrams R, Braine HG, Grever M, Hess AD, Piantadosi S, Noga SJ. CD34+ stem cell augmentation of elutriated allogeneic bone marrow grafts: results of a p — View Citation