MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia

Completed

Conditions studied: Acute Myeloid Leukemia

In brief

This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral blood and bone marrow: 1) pre-HCT (\<3 weeks prior to starting the preparative regimen), 2) day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT. For two years after transplant, the subject's follow-up data will be collected using the Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective is to determine whether there is any association between level of pre-transplant and post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival, and to estimate the strength of that association in terms of the predictive accuracy of MRD. The investigators hypothesize that measurable MRD at either time point will be associated with decreased 2-year event-free survival.

Key facts

Study ID: NCT01385787
Run by: Center for International Blood and Marrow Transplant Research
People needed: 150
Starts: 2011-10-01
Expected to finish: 2017-05-01
Last updated by the study team: 2017-09-07

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject or legal guardian to understand and voluntarily sign an informed consent.
Age 0-21 at time of transplant.
Karnofsky score ≥ 70% (age ≥ 16 years old), or Lansky score ≥ 70% (age<16 years old).
Patients with adequate physical function as measured by:
Cardiac: Left ventricular ejection fraction at rest must be > 40%, or shortening fraction > 26%
Hepatic: Bilirubin ≤ 2.5 mg/dL; and ALT, AST and Alkaline Phosphatase≤ 5 x ULN
Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) > 70 mL/min/1.73 m2.
Pulmonary: DLCO, FEV1, FVC (diffusion capacity) > 50% of predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation > 92% in room air.
Acute myelogenous leukemia (AML) at the following stages:
High risk first complete remission (CR1), defined as:
Having preceding myelodysplasia (MDS) -or-
Diagnostic high risk karyotypes: del (5q) -5, -7, abn (3q), t (6;9), abnormalities of 12, t (9:22), complex karyotype (≥3 abnormalities), the presence of a high FLT3 ITD-AR (> 0.4) -or-
Having >15% bone marrow blasts after 1st cycle and/or >5% after 2nd cycle before achieving CR -and-
<5% blasts in the bone marrow, with peripheral ANC>500
Intermediate risk first complete remission (CR1), defined as:
Diagnostic karyotypes that are neither high-risk (as defined above) nor low risk (inv(16)/t(16:16); t(8;21); t(15;17)). Included are cases where cytogenetics could not be performed. -and-
<5% blasts in the bone marrow, with peripheral ANC>500
High risk based upon COG AAML 1031 criteria:
High allelic ratio FLT3/ITD+, monosomy 7, del(5q) with any MRD status or standard risk cytogenetics with positive MRD at end of Induction I.
<5% blasts in the bone marrow, with peripheral ANC>500
Second or greater CR
<5% blasts in the bone marrow, with peripheral ANC>500
Therapy-related AML at any stage
Prior malignancy in remission for >12 months.
<5% blasts in the bone marrow, with peripheral ANC>500

You may not qualify if…

Women who are pregnant (positive HCG) or breastfeeding.
Evidence of HIV infection or HIV positive serology.
Positive viral load (PCR) for Hepatitis B or C (negative serology, surface antigen, and core antibody may substitute for PCR).
Current uncontrolled bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms).
Autologous transplant < 12 months prior to enrollment.
Prior allogeneic hematopoietic stem cell transplant.

Where it is running

The Children's Hospital of Alabama, University of Alabama at Birmingham — Birmingham, Alabama, United States
Phoenix Children's Hospital — Phoenix, Arizona, United States
Loma Linda University — Loma Linda, California, United States
University of California San Francisco — San Francisco, California, United States
The Children's Hospital Colorado — Aurora, Colorado, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Miami Children's Hospital — Miami, Florida, United States
All Children's Hospital — St. Petersburg, Florida, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Riley Hospital for Children/Indiana University — Indianapolis, Indiana, United States
University of Louisville — Louisville, Kentucky, United States
Johns Hopkins — Baltimore, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Children's Hospital of Michigan — Detroit, Michigan, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Washington University, St. Louis Children's Hospital — St Louis, Missouri, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Mount Sinai School of Medicine — New York, New York, United States
Columbia University - The Morgan Stanley Children's Hospital of New York — New York, New York, United States
New York Medical College — Valhalla, New York, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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