The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen

The Prospective Collection, Storage and Reporting of Data on Patients

To provide the IRB approved mechanism for the prospective collection, analysis and reporting of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed and for which peer reviewed, published data have demonstrated efficacy for this treatment approach.

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes; Multiple Myeloma; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Acute Lymphocytic Leukemia; Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia; Hodgkin's Disease; Germ Cell Neoplasms; Immunodeficiency Diseases

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Dianna Howard, MD; Email: dhoward@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Health
      • Principal Investigator: David Hurd, MD
      • Contact: David Hurd, MD; Phone Number: 336-716-2843; Email: dhurd@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are not on a specific "treatment research protocol" but who are nevertheless receiving "standard of care" dose intensive therapy and either an allogeneic or autologous bone marrow transplant

Description

Inclusion Criteria:

Planned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant

Exclusion Criteria:

Participation in any other treatment research protocol

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data followup	Gather basic survival and complication data for operational and research databases for ongoing regulatory and future operational queries	1 year

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Dianna Howard, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2001
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimated): July 1, 2013

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Leukemia, B-Cell; Lymphoma; Chronic Disease; Myelodysplastic Syndromes; Neoplasms, Germ Cell and Embryonal; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Hodgkin Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Immunologic Deficiency Syndromes; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: CCCWFU 95300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No