Summary

for females ages up to 29 years (full criteria)
at San Francisco, California and other locations
study started

Description

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.

Official Title

Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

Details

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.

Keywords

Acute Lymphoblastic LeukemiaAdult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-Cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-Cell LymphomaAnn Arbor Stage I Adult Burkitt LymphomaAnn Arbor Stage I Adult Hodgkin LymphomaAnn Arbor Stage I Adult Immunoblastic LymphomaAnn Arbor Stage I Adult Lymphoblastic LymphomaAnn Arbor Stage I Adult T-Cell Leukemia/LymphomaAnn Arbor Stage I Childhood Burkitt LymphomaAnn Arbor Stage I Childhood Hodgkin LymphomaAnn Arbor Stage I Childhood Lymphoblastic LymphomaAnn Arbor Stage I Grade 1 Follicular LymphomaAnn Arbor Stage I Grade 2 Follicular LymphomaAnn Arbor Stage I Grade 3 Follicular LymphomaAnn Arbor Stage I Mantle Cell LymphomaAnn Arbor Stage I Marginal Zone LymphomaAnn Arbor Stage I Non-Hodgkin LymphomaAnn Arbor Stage I Noncutaneous Childhood Anaplastic Large Cell LymphomaAnn Arbor Stage I Small Lymphocytic LymphomaAnn Arbor Stage II Adult Contiguous Immunoblastic LymphomaAnn Arbor Stage II Adult Hodgkin LymphomaAnn Arbor Stage II Adult Non-Contiguous Immunoblastic LymphomaAnn Arbor Stage II Adult T-Cell Leukemia/LymphomaAnn Arbor Stage II Childhood Burkitt LymphomaAnn Arbor Stage II Childhood Hodgkin LymphomaAnn Arbor Stage II Childhood Lymphoblastic LymphomaAnn Arbor Stage II Contiguous Adult Burkitt LymphomaAnn Arbor Stage II Contiguous Adult Lymphoblastic LymphomaAnn Arbor Stage II Contiguous Mantle Cell LymphomaAnn Arbor Stage II Grade 1 Contiguous Follicular LymphomaAnn Arbor Stage II Grade 1 Non-Contiguous Follicular LymphomaAnn Arbor Stage II Grade 2 Contiguous Follicular LymphomaAnn Arbor Stage II Grade 2 Non-Contiguous Follicular LymphomaAnn Arbor Stage II Grade 3 Contiguous Follicular LymphomaAnn Arbor Stage II Grade 3 Non-Contiguous Follicular LymphomaAnn Arbor Stage II Marginal Zone LymphomaAnn Arbor Stage II Non-Contiguous Adult Burkitt LymphomaAnn Arbor Stage II Non-Contiguous Adult Lymphoblastic LymphomaAnn Arbor Stage II Non-Contiguous Mantle Cell LymphomaAnn Arbor Stage II Non-Hodgkin LymphomaAnn Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell LymphomaAnn Arbor Stage II Small Lymphocytic LymphomaAnn Arbor Stage III Adult Burkitt LymphomaAnn Arbor Stage III Adult Hodgkin LymphomaAnn Arbor Stage III Adult Immunoblastic LymphomaAnn Arbor Stage III Adult Lymphoblastic LymphomaAnn Arbor Stage III Adult T-Cell Leukemia/LymphomaAnn Arbor Stage III Childhood Burkitt LymphomaAnn Arbor Stage III Childhood Hodgkin LymphomaAnn Arbor Stage III Childhood Lymphoblastic LymphomaAnn Arbor Stage III Grade 1 Follicular LymphomaAnn Arbor Stage III Grade 2 Follicular LymphomaAnn Arbor Stage III Grade 3 Follicular LymphomaAnn Arbor Stage III Mantle Cell LymphomaAnn Arbor Stage III Marginal Zone LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell LymphomaAnn Arbor Stage III Small Lymphocytic LymphomaAnn Arbor Stage IV Adult Burkitt LymphomaAnn Arbor Stage IV Adult Hodgkin LymphomaAnn Arbor Stage IV Adult Immunoblastic LymphomaAnn Arbor Stage IV Adult Lymphoblastic LymphomaAnn Arbor Stage IV Adult T-Cell Leukemia/LymphomaAnn Arbor Stage IV Childhood Burkitt LymphomaAnn Arbor Stage IV Childhood Hodgkin LymphomaAnn Arbor Stage IV Childhood Lymphoblastic LymphomaAnn Arbor Stage IV Grade 1 Follicular LymphomaAnn Arbor Stage IV Grade 2 Follicular LymphomaAnn Arbor Stage IV Grade 3 Follicular LymphomaAnn Arbor Stage IV Mantle Cell LymphomaAnn Arbor Stage IV Marginal Zone LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAnn Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell LymphomaAnn Arbor Stage IV Small Lymphocytic LymphomaChildhood Burkitt LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic LymphomaChildhood Nasal Type Extranodal NK/T-Cell LymphomaExtranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueHairy Cell LeukemiaHepatosplenic T-Cell LymphomaIntraocular LymphomaLymphomatous Involvement of Non-Cutaneous Extranodal SiteMature T-Cell and NK-Cell Non-Hodgkin LymphomaNodal Marginal Zone LymphomaNon-Hodgkin LymphomaPrimary Cutaneous B-Cell Non-Hodgkin LymphomaProgressive Hairy Cell Leukemia Initial TreatmentSmall Intestinal LymphomaSplenic Marginal Zone LymphomaStage 0 Chronic Lymphocytic LeukemiaStage I Chronic Lymphocytic LeukemiaStage I Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7Stage II Chronic Lymphocytic LeukemiaStage II Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7Stage III Chronic Lymphocytic LeukemiaStage III Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IV Chronic Lymphocytic LeukemiaStage IV Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7T-Cell Large Granular Lymphocyte LeukemiaTesticular LymphomaUntreated Adult Acute Lymphoblastic LeukemiaUntreated Childhood Acute Lymphoblastic LeukemiaUntreated Hairy Cell LeukemiaWaldenstrom MacroglobulinemiaLymphomaSyndromeLeukemiaLymphoma, FollicularLymphoma, Non-HodgkinLeukemia, LymphoidPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellHodgkin DiseaseLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLymphoma, T-CellBurkitt LymphomaMycosesMycosis FungoidesSezary SyndromeLeukemia, T-CellLeukemia-Lymphoma, Adult T-CellLymphoma, B-CellLymphoma, Large-Cell, AnaplasticLeukemia, Hairy CellLymphomatoid GranulomatosisLymphoma, Extranodal NK-T-CellImmunoblastic LymphadenopathyLeukemia, Large Granular LymphocyticPlasmablastic LymphomaLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, PeripheralLaboratory Biomarker AnalysisQuestionnaire AdministrationAncillary-Correlative (menstrual diary, biomarker analysis)

Eligibility

You can join if…

Open to females ages up to 29 years

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center-Parnassus
    San FranciscoCalifornia94143United States
  • UCSF Medical Center-Mission Bay
    San FranciscoCalifornia94158United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT01793233
Study Type
Observational
Last Updated