MedDataX Logo

Comparing Autologous Peripheral Blood Stem Cell to Bone Marrow Transplantation for Recurrent Non-Hodgkin's Lymphoma

NCT ID: NCT00574626

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-12-12

Study Completion Date

2010-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with intermediate grade NHL with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our transplant program.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be stratified according to good and poor prognosis category and relapsed vs. first partial response categories. The patients will have bone marrow or peripheral stem cells collected according to standard protocols. A standardized hematopoietic growth factor will be used for mobilization and post-transplant. The patients' PSC or bone marrow (BM) product will be assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays. The patients' outcome for transplantation will be evaluated with response to transplantation, relapse rates and event free survival being the measured end points.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NHL Non Hodgkins Lymphoma BMT Bone Marrow Transplant PBSCT Peripheral Blood Stem Cell Transplant PSCT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Peripheral Blood Stem Cell Transplant

Peripheral Blood Stem Cell Transplant

Group Type EXPERIMENTAL

PBSCT

Intervention Type PROCEDURE

Peripheral Blood Stem Cell Transplant

Bone Marrow Transplantation

Bone Marrow Transplantation

Group Type ACTIVE_COMPARATOR

Bone Marrow Transplant

Intervention Type PROCEDURE

Bone Marrow Transplant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PBSCT

Peripheral Blood Stem Cell Transplant

Intervention Type PROCEDURE

Bone Marrow Transplant

Bone Marrow Transplant

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 16-65
* Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status \> 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue.

Exclusion Criteria

* Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible.
* Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process.
* Patients who do not otherwise meet high-dose therapy and transplantation entry criteria.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julie M Vose, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0123-92-FB

Identifier Type: -

Identifier Source: org_study_id