Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant
IROPAST
1 other identifier
observational
31
1 country
1
Brief 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 system during reconstitution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 14, 2015
July 1, 2015
3.3 years
February 17, 2012
July 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the immune reconstitution of T cell, B cell, and NK cell compartment.
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 transplant) to the baseline values using paired one sample signed rank test.
Days 0, 14, 21, 28, week 8, and months 3, 6, 12, and 18 related to stem cell infusion.
Study Arms (1)
Participants
Participants enrolled on the study will have blood samples obtained.
Interventions
Research participants agree to have blood samples obtained at the time of diagnosis before any chemotherapy, if available, and prior to high dose chemotherapy regimen with autologous HSCT as well as on days 14, 21, 28, week 8 and months 3, 6, 12 and 18 after autologous HSCT. Research participants with high risk neuroblastoma may also agree to have blood samples taken before and twice in the recovery period (days 0, 7 and 15-18) of Induction chemotherapy courses one and four.
Eligibility Criteria
Participants will have a diagnosis of solid tumor, brain tumor or lymphoma, be 21 years of age or younger, and be enrolled on a protocol likely to include autologous stem cell transplant.
You may qualify if:
- Patients with solid tumors, brain tumors or lymphoma regardless of previously received cancer related therapies who are enrolled on a study protocol or treatment plan that includes or will likely include autologous stem cell transplant.
- Patient age \>0 to 21 years
You may not qualify if:
- Patient receiving an autologous transplant for a disease other than listed above.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38103, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee Talleur, MD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
February 28, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 14, 2015
Record last verified: 2015-07