Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant (IROPAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01540175
First received: February 17, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Solid Tumor
Brain Tumor
Lymphoma
Other: Blood samples obtained

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Change in the immune reconstitution of T cell, B cell, and NK cell compartment. [ Time Frame: Days 0, 14, 21, 28, week 8, and months 3, 6, 12, and 18 related to stem cell infusion. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants
Participants enrolled on the study will have blood samples obtained.
Other: Blood samples obtained
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.

Detailed Description:

Primary Objective:

  • To describe the immune reconstitution of T cell-, B cell- and natural killer (NK) cell- compartment in patients undergoing autologous stem cell transplant as part of their treatment for a malignancy.

The design for this study will be a prospective, longitudinal observational study. Immune reconstitution will be measured in the course of autologous stem cell transplant using serial blood samples analyzed for cell counts, immune cell phenotyping (demonstrating the expression of specific receptors on the cell surface) and functional lymphocyte assays. These blood samples will be obtained once prior and at defined time points after stem cell infusion either while the research participant is hospitalized or during the scheduled clinic visit.

Immune recovery from conventional chemotherapy will be measured using serial blood samples analyzed for cell counts, immune cell phenotyping, and NK cell functional assays. These blood samples will be obtained once prior and at defined time points after completion of courses #1 and #4 of Induction chemotherapy while the research participant is hospitalized or during the scheduled clinic visit.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient receiving an autologous transplant for a disease other than listed above.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540175

Contacts
Contact: Susanne Wendt, MD 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Susanne Wendt, MD    866-278-5833    info@stjude.org   
Principal Investigator: Susanne Wendt, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Susanne Wendt, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01540175     History of Changes
Other Study ID Numbers: XPD12-013 IROPAST
Study First Received: February 17, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Autologous stem cell transplant
Immune reconstitution

Additional relevant MeSH terms:
Brain Neoplasms
Lymphoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014