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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: Completed study of Lymphoma and Solid Tumor, sponsored by St. Jude Children's Research Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The order and magnitude of recovery of the different subtypes of leukocytes will be summarized by descriptive statistics. The pattern of immune reconstitution will be evaluated using longitudinal approaches such as Mixed effect models or GEE approach and implement in SAS 9.2 using PROC MIXED or PROC GENMOD. In addition, NK cell number, receptor and ligand genotype and phenotype and functional capacity will be compared at specific time points (28 days, 8 weeks and 6 months post autologous transp
Conditions Studied
Interventions
- OTHER Blood samples obtained
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-06 |
What the finished NCT01540175 record still lists
NCT01540175 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01540175's enrollment target sits among peer trials
31 213th of 299 higher than 87 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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