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Anaplastic Large Cell LymphomaNCT01793233

Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

An observational study of Anaplastic Large Cell Lymphoma and Burkitt Lymphoma, run by Children's Oncology Group at 107 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure. Read more about this study

Who is it for?
Ages Up to 29 years, women only
What is being tested?
Laboratory Biomarker Analysis and Questionnaire Administration
How many people
203 participants
Where
107 sitesin 2 countries
Study dates
17 Jun 2013to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 29 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Study population: Patients with newly diagnosed lymphoma at Children's Oncology Group

Who may be able to join

  • Patients must have had first menses >= 6 months prior to enrollment
  • Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma
  • Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year
  • Patients with any performance status are eligible for enrollment
  • Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues
  • 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

Who cannot join

  • Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible
  • Patients who have a secondary malignancy are not eligible
  • Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible
  • Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible
  • Patients who previously have had their uterus or ovary(ies) removed are not eligible
  • Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible
  • Patients who are pregnant or breast feeding are not eligible
  • Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible

Trial locations and contacts

107 sites in 2 countries.

107 sites in 2 countries

United States97 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia, 30322

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • T C Thompson Children's Hospital

    Chattanooga, Tennessee, 37403

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Missouri Children's Hospital

    Columbia, Missouri, 65212

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • East Carolina University

    Greenville, North Carolina, 27834

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada, 89169

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Nemours Children's Hospital

    Orlando, Florida, 32827

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

  • UCSF Medical Center-Parnassus

    San Francisco, California, 94143

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

  • New York Medical College

    Valhalla, New York, 10595

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Saint Mary's Hospital

    West Palm Beach, Florida, 33407

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada10 sites

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Children's Hospital

    London, Ontario, N6A 5W9

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    Québec, G1V 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare anti mullerian hormone (AMH), follicle stimulating hormone (FSH), and estradiol (E2) between patients at baseline and cross section of controls and again between patients at 12 months off therapy and cross section of controls.

II. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

III. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.

IV. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.

SECONDARY OBJECTIVES:

  1. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.

OUTLINE:

Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collection at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.

Being tested
Laboratory Biomarker Analysis, Questionnaire Administration
Medical subject headings
Lymphoma, Large-Cell, Anaplastic, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT01793233
Study groupRoleWhat they receive
Ancillary-Correlative (menstrual diary, biomarker analysis)Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collections at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.
Receives: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls

    Compared using the Wilcoxon rank-sum test or the two sample t-test after appropriate transformation. Analysis of covariance will be used to adjust these comparisons for covariates including age, race, dose of alkylating agent and use of hormone medications.

    Measured: Up to 12 months

  2. Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline

    Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.

    Measured: Baseline up to end of chemotherapy

  3. Degree of recovery of AMH, FSH, and E2 in the post-therapy phase

    Generalized estimating equation (GEE) will be used to model the change as a function of time.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Rate of AOF

    Describe the number of patients with AOF as measured at 12 months by an FSH > 40 divided by the total population.

    Measured: Up to 12 months

  2. Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms

    Describe the number of samples collected.

    Measured: At enrollment (or diagnosis) and Day 5 post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2013 (estimated)
  2. Study start17 Jun 2013
  3. Primary completion31 Dec 2022
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01793233
Sponsor's protocol ID
ALTE11C1
Other IDs
NCI-2013-00069, ALTE11C1, COG-ALTE11C1, ALTE11C1, U10CA095861, UG1CA189955
Status last verified
Aug 2024
First submitted
13 Feb 2013
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Anaplastic Large Cell Lymphoma and Burkitt Lymphoma, run by Children's Oncology Group at 107 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01793233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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