Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60611


Purpose:

RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.


Study summary:

OBJECTIVES: - Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation. - Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population. OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0. Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover. Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years. PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols - HLA-identical or one antigen-mismatched related donor PATIENT CHARACTERISTICS: Age: - 10 to 65 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No known sensitivity to E. coli derivatives PRIOR CONCURRENT THERAPY: - See Disease Characteristics


Study is Available At:


Original ID:

NU FDA96H4


NCT ID:

NCT00004232


Secondary ID:

NU-96H4


Study Acronym:


Brief Title:

Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer


Official Title:

Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

10 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Supportive Care


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Richard K. Burt, MD
Study Chair
Robert H. Lurie Cancer Center

Study Dates

Start Date:October 1999
Completion Date:October 2002
Completion Type:Actual
Primary Completion Date:October 2002
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 31, 2012
First Received Date:January 28, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:filgrastim
Intervention Type:Drug
Name:cyclosporine
Intervention Type:Drug
Name:methylprednisolone
Intervention Type:Drug
Name:prednisone
Intervention Type:Procedure
Name:allogeneic bone marrow transplantation
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.