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NCT01540175 · ClinicalTrials.gov registry record

Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant

A clinical trial of Lymphoma and Solid Tumor, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
31
Enrollment target
1
Study location

NCT01540175 is a study of Lymphoma and Solid Tumor that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 31 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01540175, a study of Lymphoma and Solid Tumor, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
31 participants
Enrollment target
1
Study location

Study Summary

Autologous stem cell rescue is an established therapy in high risk neuroblastoma and relapsed Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors to facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is usually tolerated with acceptable toxicity and graft failure is practically not existent. But whereas immune reconstitution in allogeneic hematopoietic stem cell transplantation (HSCT) setting is widely studied, the investigators have no comprehensive data available in the autologous setting regarding recovery of the innate and adaptive immune system. However, observations in patients with autoimmune disease undergoing autologous HSCT suggest not an exact recovery of the patient's pre-transplant immune system but some re-education during reconstitution of immune function. Also, recent developments of cancer-directed immunotherapy with monoclonal antibodies and immunocytokines rely on activity of the patient's own immune system via complement-mediated or antibody-dependent cellular cytotoxicity. These novel therapies are given either with or shortly after conventional chemotherapy. To find the optimal time point for administration of immunotherapy, it is important to know how and when immune effector cells recover after conventional myelosuppressive and/or immunosuppressive chemotherapy which are used in Induction regimens. Researchers at St. Jude Children's Research Hospital want to study the research participant's immune profile once prior and at multiple set time points after autologous stem cell infusion during the recovery process. In a subset of participants the investigators want to study the recovery of lymphocyte subsets and function after one course of conventional chemotherapy preceding the high dose chemotherapy and autologous stem cell transplant. That way the investigators hope to learn about the pace and order of recovery and the functional capacity of different compartments of the immune s

Interventions

  • OTHER Blood samples obtained

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2012-03
Est. Completion 2015-06

What the Registry Record Tells You About NCT01540175

The ClinicalTrials.gov registry entry for NCT01540175 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Blood samples obtained is the first listed.

NCT01540175 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT01540175 about?

NCT01540175 is a clinical study titled "Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant". Autologous stem cell rescue is an established therapy in high risk neuroblastoma and relapsed Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors to facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is usually tolerated with acceptable t...

What is the current status of trial NCT01540175?

This trial is currently completed. The enrollment target is 31 participants. The study started on 2012-03. Estimated completion is 2015-06.

What conditions does trial NCT01540175 study?

This clinical trial studies the following conditions: Lymphoma, Solid Tumor, Brain Tumor.

What interventions are being tested in trial NCT01540175?

The interventions under investigation include: Blood samples obtained (OTHER).

Who is sponsoring clinical trial NCT01540175?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01540175 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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