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Early Chimerism Following Allogeneic Stem-Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03689907
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : May 18, 2020
Information provided by (Responsible Party):
John M. Hill, Jr., MD, Dartmouth-Hitchcock Medical Center

Brief Summary:

Allogeneic stem cell transplant (allo-SCT) is a common treatment for variety of blood cancers. To determine how much of your cells are from your donor after transplant, doctors complete a "chimerism analysis" or a test of your cells to look at the DNA. Chimerism testing helps doctors predict graft rejection or recurrence of disease. Doctors at NCCC do chimerism testing routinely and it is usually done between 30 and 100 days after transplantation. The researchers believe that analyzing chimerism sooner than 30 days after transplant may help identify problems earlier, get patients treatment sooner, and increase the chances of a successful transplant.

The purpose of this study is to find out if doing chimerism testing earlier than the traditional approach is better for patient outcomes (about 14 days after transplantation rather than 30+ days). We hope the information gained from this study can be used to help prevent some post-transplant complications such as graft loss, graft-versus-host disease, or even relapse for future patients.

Also, the researchers hope to learn more about chimerism testing of cells of patients with haploidentical donors (donors who are only a "half-match" - such as a parent or child of the recipient), because there have not been many chimerism analysis studies done in this population

Condition or disease Intervention/treatment
Allogeneic Stem-Cell Transplant Other: Chimerism Evaluation

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Group/Cohort Intervention/treatment
Allogeneic Stem-Cell Transplant Recipients
  1. At day +14/15-post transplant - lineage-specific chimerism analysis will be performed on a peripheral blood sample drawn from the patient.
  2. At day +30-post transplant, most participants will be in the outpatient setting and would undergo chimerism evaluation as part of the standard of care for transplant patients.
Other: Chimerism Evaluation
Blood collection for chimerism evaluation will be performed on days +14/15-post transplant and +30-post transplant for each study participant.

Primary Outcome Measures :
  1. Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients [ Time Frame: 14 or 15 days post-transplant ]
    Our method of chimerism analysis is dependent on baseline DNA samples of pre-transplant donor and recipient, then serial assessment of polymorphic short tandem repeats (STRs) to specifically characterize the source (donor vs recipient) of DNA extracted from our patients' leukocytes at day +14/15 after allogeneic stem cell transplant. First, DNA is extracted from the buffy coat layer of an EDTA blood sample, then PCR reactions using STR markers are prepared, and the differently sized fluorescent PCR products are then assessed on a genetic analyzer. An assessment of the relative amounts of donor and recipient chimerism can then be determined from the analyzer output, based on peak height and area. The discreet leukocyte lineages are then isolated by cell separation, and DNA is isolated from these purified fractions and assessed as for whole blood.

Secondary Outcome Measures :
  1. Correlate early chimersim profiles with donor chimerism [ Time Frame: Day +30-post transplant ]
    Day +14/15-post transplant absolute neutrophil count and absolute lymphocyte count will be compared to the Day +30-post transplant lineage-specific chimerism profile to determine if there is a correlation between early lineage chimerism and full donor chimerism.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All participants in this study will receive an allogeneic stem-cell transplant.

Inclusion Criteria:

  • All patients will have been cleared by a Transplant Attending to undergo allogeneic stem cell transplant

Exclusion Criteria:

  • Patients undergoing a second allogeneic stem cell transplant or beyond

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03689907

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Contact: Research Nurse (800) 639-6918

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United States, New Hampshire
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: John M Hill, MD    603-650-4628   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
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Principal Investigator: John M. Hill, MD Dartmouth-Hitchcock Medical Center
Mathur, A and Malhotra, H. Haploidentical Stem Cell Transplantation: A Mini Review. J Stem Cell Res Ther 2017; 2(2): 00056.
Legrand, F et al. Chimerism Analysis after Haploidentical Stem Cell Transplantation: Is It Necessary for All Patients? Blood 2016; 128: 3417.
Hussain, A et al. Lineage-Specific Chimerism and Incidence of Graft Failure Following T-Cell Replete Haploidentical Transplantation Using Post-Transplant Cyclophosphamide in Eighty-Nine Consecutive Patients From a Single Center. Blood 2012; 120: 3030.
Choi, YB et al. Does Day 14 Peripheral Blood Chimerism after Allogeneic Hematopoietic Stem Cell Transplantation Predict Treatment Failure in Children with Non-Malignant Disease? BBMT 2016; 22: S310.

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Responsible Party: John M. Hill, Jr., MD, Director, Allogeneic Bone Marrow Transplant Program, Dartmouth-Hitchcock Medical Center Identifier: NCT03689907    
Other Study ID Numbers: D18125
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No