A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years to 39 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at long-term health after treatment for acute leukemia, a fast-growing blood cancer. It is for people ages 6 to 39 with Down syndrome who finished cancer treatment at least 3 years ago. The goal is to help improve care after cancer treatment.
This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 6 to 39 when joining the study.
- Have Down syndrome. Any of the three types is allowed.
- Have been treated for acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). This includes myeloid leukemia of Down syndrome, including myelodysplastic syndrome, a bone marrow disorder.
- Have finished all cancer treatment at least 36 months ago. People whose leukemia came back may join if they meet all study rules.
- Be expected to live more than 1 year.
- The patient and parent must speak English or Spanish. At least one parent or guardian must read and write in English or Spanish and complete all surveys, even for adult patients.
- The patient and/or parent or legal guardian must sign a form agreeing to join.
- All required rules for research with people must be met.
Who can't join
- Have had a blood-forming stem cell transplant. Past CAR T-cell therapy or other cancer treatments using cells are allowed if all other study rules are met.
- Have had another cancer before or after the ALL or AML diagnosis.
- Have a parent or guardian who cannot complete the required forms.
- Have only had transient abnormal myelopoiesis (TAM), a temporary blood cell disorder, without qualifying leukemia. Past TAM is allowed but does not qualify someone on its own.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patients age \>= 6 and \< 40 years at the time of enrollment * A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells) * All patients must be DS-AL survivors (acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\]) * Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant * Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study * Patients must have been treated for ALL or AML * Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above * All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment * Patients must have a life expectancy of \> 1 year * Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish * Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are \>= 18 years old * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Patients with history of hematopoietic stem cell transplant (HSCT) are excluded * Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied * Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded * Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility * Patients whose parents or guardians are unable to complete the required forms are excluded
Study sites (72)
AL
- Children's Hospital of Alabama · Birmingham, AL 35233Site Public Contact · Study contact · 205-638-9285 · oncologyresearch@peds.uab.eduSmita Bhatia · Principal investigatorMore trials in Birmingham
AZ
- Phoenix Childrens Hospital · Phoenix, AZ 85016Site Public Contact · Study contact · 602-546-0920Alexandra M. Walsh · Principal investigatorMore trials in Phoenix
CA
- Valley Children's Hospital · Madera, CA 93636Site Public Contact · Study contact · 559-353-3000 · Research@valleychildrens.orgRuetima Titapiwatanakun · Principal investigatorMore trials in Madera
- UCSF Benioff Children's Hospital Oakland · Oakland, CA 94609Site Public Contact · Study contact · 510-428-3264 · PedOncRschOAK@ucsf.eduKaren R. Rabin · Principal investigatorMore trials in Oakland
- Kaiser Permanente-Oakland · Oakland, CA 94611Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgAarati V. Rao · Principal investigatorMore trials in Oakland
- University of California Davis Comprehensive Cancer Center · Sacramento, CA 95817Site Public Contact · Study contact · 916-734-3089Marcio H. Malogolowkin · Principal investigatorMore trials in Sacramento
- Rady Children's Hospital - San Diego · San Diego, CA 92123Site Public Contact · Study contact · 858-966-5934William D. Roberts · Principal investigatorMore trials in San Diego
- UCSF Medical Center-Mission Bay · San Francisco, CA 94158Site Public Contact · Study contact · 877-827-3222 · cancertrials@ucsf.eduKaren R. Rabin · Principal investigatorMore trials in San Francisco
CT
- Yale University · New Haven, CT 06520Site Public Contact · Study contact · 203-785-5702 · canceranswers@yale.eduRozalyn L. Rodwin · Principal investigatorMore trials in New Haven
DE
- Alfred I duPont Hospital for Children · Wilmington, DE 19803Site Public Contact · Study contact · 302-651-5572 · Allison.bruce@nemours.orgVibhuti Agarwal · Principal investigatorMore trials in Wilmington
FL
- Golisano Children's Hospital of Southwest Florida · Fort Myers, FL 33908Site Public Contact · Study contact · 239-343-5333 · molly.arnstrom@leehealth.orgEmad K. Salman · Principal investigatorMore trials in Fort Myers
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital · Hollywood, FL 33021Site Public Contact · Study contact · 954-265-1847 · OHR@mhs.netIftikhar Hanif · Principal investigatorMore trials in Hollywood
- Nemours Children's Clinic-Jacksonville · Jacksonville, FL 32207Site Public Contact · Study contact · 302-651-5572 · Allison.bruce@nemours.orgVibhuti Agarwal · Principal investigatorMore trials in Jacksonville
- Nemours Children's Hospital · Orlando, FL 32827Site Public Contact · Study contact · 302-651-5572 · Allison.bruce@nemours.orgVibhuti Agarwal · Principal investigatorMore trials in Orlando
- Nemours Children's Clinic - Pensacola · Pensacola, FL 32504Site Public Contact · Study contact · helpdesk@childrensoncologygroup.orgJeffrey H. Schwartz · Principal investigatorMore trials in Pensacola
- Saint Joseph's Hospital/Children's Hospital-Tampa · Tampa, FL 33607Site Public Contact · Study contact · 813-357-0849 · jennifer.manns@baycare.orgDon E. Eslin · Principal investigatorMore trials in Tampa
GA
- Children's Healthcare of Atlanta - Arthur M Blank Hospital · Atlanta, GA 30329Site Public Contact · Study contact · 404-785-0232 · Olivia.Floyd@choa.orgKaren E. Effinger · Principal investigatorMore trials in Atlanta
- Augusta University Medical Center · Augusta, GA 30912Site Public Contact · Study contact · 706-721-2388 · ga_cares@augusta.eduColleen H. McDonough · Principal investigatorMore trials in Augusta
HI
- Kapiolani Medical Center for Women and Children · Honolulu, HI 96826Site Public Contact · Study contact · 808-983-6090Wade T. Kyono · Principal investigatorMore trials in Honolulu
IL
- Lurie Children's Hospital-Chicago · Chicago, IL 60611Site Public Contact · Study contact · 773-880-4562Lindsay F. Schwartz · Principal investigatorMore trials in Chicago
- University of Chicago Comprehensive Cancer Center · Chicago, IL 60637Site Public Contact · Study contact · 773-702-8222 · cancerclinicaltrials@bsd.uchicago.eduGabrielle Lapping-Carr · Principal investigatorMore trials in Chicago
MD
- Sinai Hospital of Baltimore · Baltimore, MD 21215Site Public Contact · Study contact · 410-601-9083Jason M. Fixler · Principal investigatorMore trials in Baltimore
MI
- C S Mott Children's Hospital · Ann Arbor, MI 48109Site Public Contact · Study contact · 800-865-1125Joshua W. Goldman · Principal investigatorMore trials in Ann Arbor
- Children's Hospital of Michigan · Detroit, MI 48201Site Public Contact · Study contact · helpdesk@childrensoncologygroup.orgAlissa M. Martin · Principal investigatorMore trials in Detroit
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital · Grand Rapids, MI 49503Site Public Contact · Study contact · 616-391-1230 · crcwm-regulatory@crcwm.orgKathleen Y. Butler · Principal investigatorMore trials in Grand Rapids
- Bronson Methodist Hospital · Kalamazoo, MI 49007Site Public Contact · Study contact · 616-391-1230 · crcwm-regulatory@crcwm.orgKathleen Y. Butler · Principal investigatorMore trials in Kalamazoo
MN
- Children's Hospitals and Clinics of Minnesota - Minneapolis · Minneapolis, MN 55404Site Public Contact · Study contact · 612-813-5913 · pauline.mitby@childrensmn.orgMichael K. Richards · Principal investigatorMore trials in Minneapolis
- University of Minnesota/Masonic Cancer Center · Minneapolis, MN 55455Site Public Contact · Study contact · 612-624-2620Karim T. Sadak · Principal investigatorMore trials in Minneapolis
MO
- Children's Mercy Hospitals and Clinics · Kansas City, MO 64108Site Public Contact · Study contact · 816-302-6808 · COGResearchGroup@cmh.eduKeith J. August · Principal investigatorMore trials in Kansas City
- Washington University School of Medicine · St Louis, MO 63110Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduRobert J. Hayashi · Principal investigatorMore trials in St Louis
MS
- University of Mississippi Medical Center · Jackson, MS 39216Site Public Contact · Study contact · 601-815-6700Amanda Strobel · Principal investigatorMore trials in Jackson
NC
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC 27599Site Public Contact · Study contact · 877-668-0683 · cancerclinicaltrials@med.unc.eduThomas B. Alexander · Principal investigatorMore trials in Chapel Hill
- Wake Forest University Health Sciences · Winston-Salem, NC 27157Site Public Contact · Study contact · 336-713-6771Sarah Supples · Principal investigatorMore trials in Winston-Salem
ND
- Sanford Broadway Medical Center · Fargo, ND 58122Site Public Contact · Study contact · 701-323-5760 · OncologyClinicalTrialsFargo@sanfordhealth.orgSamuel J. Milanovich · Principal investigatorMore trials in Fargo
NE
- Children's Hospital and Medical Center of Omaha · Omaha, NE 68114Site Public Contact · Study contact · 402-955-3949Jill C. Beck · Principal investigatorMore trials in Omaha
- University of Nebraska Medical Center · Omaha, NE 68198Site Public Contact · Study contact · 402-559-6941 · unmcrsa@unmc.eduJill C. Beck · Principal investigatorMore trials in Omaha
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601Site Public Contact · Study contact · 551-996-2897Katharine R. Lange · Principal investigatorMore trials in Hackensack
NV
- University Medical Center of Southern Nevada · Las Vegas, NV 89102Site Public Contact · Study contact · 702-384-0013 · research@sncrf.orgAlan K. Ikeda · Principal investigatorMore trials in Las Vegas
- Sunrise Hospital and Medical Center · Las Vegas, NV 89109Site Public Contact · Study contact · 702-384-0013 · research@sncrf.orgAlan K. Ikeda · Principal investigatorMore trials in Las Vegas
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation · Las Vegas, NV 89135Site Public Contact · Study contact · 702-384-0013 · research@sncrf.orgAlan K. Ikeda · Principal investigatorMore trials in Las Vegas
- Summerlin Hospital Medical Center · Las Vegas, NV 89144Site Public Contact · Study contact · 702-384-0013 · research@sncrf.orgAlan K. Ikeda · Principal investigatorMore trials in Las Vegas
- Renown Regional Medical Center · Reno, NV 89502Site Public Contact · Study contact · 775-982-5050 · Renown-CRD@renown.orgAlan K. Ikeda · Principal investigatorMore trials in Reno
NY
- Albany Medical Center · Albany, NY 12208Site Public Contact · Study contact · 518-262-5513Lauren R. Weintraub · Principal investigatorMore trials in Albany
- Roswell Park Cancer Institute · Buffalo, NY 14263Site Public Contact · Study contact · 800-767-9355 · askroswell@roswellpark.orgDenise A. Rokitka · Principal investigatorMore trials in Buffalo
- Montefiore Medical Center - Moses Campus · The Bronx, NY 10467Site Public Contact · Study contact · 718-379-6866 · eskwak@montefiore.orgAlice Lee · Principal investigatorMore trials in The Bronx
OH
- Children's Hospital Medical Center of Akron · Akron, OH 44308Site Public Contact · Study contact · 330-543-3193Erin Wright · Principal investigatorMore trials in Akron
- Rainbow Babies and Childrens Hospital · Cleveland, OH 44106Site Public Contact · Study contact · 216-844-5437Duncan S. Stearns · Principal investigatorMore trials in Cleveland
- Cleveland Clinic Foundation · Cleveland, OH 44195Site Public Contact · Study contact · 866-223-8100 · TaussigResearch@ccf.orgMatteo M. Trucco · Principal investigatorMore trials in Cleveland
- Nationwide Children's Hospital · Columbus, OH 43205Site Public Contact · Study contact · 614-722-6039 · Melinda.Triplet@nationwidechildrens.orgMark A. Ranalli · Principal investigatorMore trials in Columbus
- Dayton Children's Hospital · Dayton, OH 45404Site Public Contact · Study contact · 800-228-4055Jordan M. Wright · Principal investigatorMore trials in Dayton
OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK 73104Site Public Contact · Study contact · 405-271-8777 · ou-clinical-trials@ouhsc.eduRene Y. McNall-Knapp · Principal investigatorMore trials in Oklahoma City
OR
- Oregon Health and Science University · Portland, OR 97239Site Public Contact · Study contact · 503-494-1080 · trials@ohsu.eduSusan J. Lindemulder · Principal investigatorMore trials in Portland
PA
- Children's Hospital of Philadelphia · Philadelphia, PA 19104Site Public Contact · Study contact · 267-425-5544 · CancerTrials@email.chop.eduSogol Mostoufi-Moab · Principal investigatorMore trials in Philadelphia
- Children's Hospital of Pittsburgh of UPMC · Pittsburgh, PA 15224Site Public Contact · Study contact · 412-692-8570 · jean.tersak@chp.eduJean M. Tersak · Principal investigatorMore trials in Pittsburgh
RI
- Rhode Island Hospital · Providence, RI 02903Site Public Contact · Study contact · 401-444-1488Bradley DeNardo · Principal investigatorMore trials in Providence
SC
- Prisma Health Richland Hospital · Columbia, SC 29203Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgStuart L. Cramer · Principal investigatorMore trials in Columbia
- BI-LO Charities Children's Cancer Center · Greenville, SC 29605Site Public Contact · Study contact · 864-522-4317 · Kim.Williams3@prismahealth.orgAniket Saha · Principal investigatorMore trials in Greenville
SD
- Sanford USD Medical Center - Sioux Falls · Sioux Falls, SD 57117-5134Site Public Contact · Study contact · 605-312-3320 · OncologyClinicalTrialsSF@SanfordHealth.orgJordan Fritch-Hanson · Principal investigatorMore trials in Sioux Falls
TN
- East Tennessee Childrens Hospital · Knoxville, TN 37916Site Public Contact · Study contact · 865-541-8266Susan E. Spiller · Principal investigatorMore trials in Knoxville
- Saint Jude Children's Research Hospital · Memphis, TN 38105Site Public Contact · Study contact · 888-226-4343 · referralinfo@stjude.orgLisa Jacola · Principal investigatorMore trials in Memphis
- Vanderbilt University/Ingram Cancer Center · Nashville, TN 37232Site Public Contact · Study contact · 800-811-8480Debra L. Friedman · Principal investigatorMore trials in Nashville
TX
- Dell Children's Medical Center of Central Texas · Austin, TX 78723Site Public Contact · Study contact · 512-628-1902 · TXAUS-DL-SFCHemonc.research@ascension.orgShannon M. Cohn · Principal investigatorMore trials in Austin
- UT Southwestern/Simmons Cancer Center-Dallas · Dallas, TX 75390Site Public Contact · Study contact · 214-648-7097 · canceranswerline@UTSouthwestern.eduKsenya Shliakhtsitsava · Principal investigatorMore trials in Dallas
- Cook Children's Medical Center · Fort Worth, TX 76104Site Public Contact · Study contact · 682-885-2103 · CookChildrensResearch@cookchildrens.orgDonald T. Beam · Principal investigatorMore trials in Fort Worth
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center · Houston, TX 77030Site Public Contact · Study contact · 713-798-1354 · burton@bcm.eduOmar Shakeel · Principal investigatorMore trials in Houston
- UT MD Anderson Cancer Center · Houston, TX 77030Site Public Contact · Study contact · 866-632-6789 · askmdanderson@mdanderson.orgNajat C. Daw · Principal investigatorMore trials in Houston
- University of Texas Health Science Center at San Antonio · San Antonio, TX 78229Site Public Contact · Study contact · 210-450-3800 · phoresearchoffice@uthscsa.eduShafqat Shah · Principal investigatorMore trials in San Antonio
WA
- Seattle Children's Hospital · Seattle, WA 98105Site Public Contact · Study contact · 866-987-2000Sarah E. Leary · Principal investigatorMore trials in Seattle
- Providence Sacred Heart Medical Center and Children's Hospital · Spokane, WA 99204Site Public Contact · Study contact · 800-228-6618 · HopeBeginsHere@providence.orgJudy L. Felgenhauer · Principal investigatorMore trials in Spokane
WI
- University of Wisconsin Carbone Cancer Center - University Hospital · Madison, WI 53792Site Public Contact · Study contact · 800-622-8922 · clinicaltrials@cancer.wisc.eduCathy A. Lee-Miller · Principal investigatorMore trials in Madison
- Marshfield Medical Center-Marshfield · Marshfield, WI 54449Site Public Contact · Study contact · 800-782-8581 · oncology.clinical.trials@marshfieldresearch.orgMichelle A. Manalang · Principal investigatorMore trials in Marshfield
- Children's Hospital of Wisconsin · Milwaukee, WI 53226Site Public Contact · Study contact · 414-955-4727 · MACCCTO@mcw.eduRachel A. Phelan · Principal investigatorMore trials in Milwaukee