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 Leukemia Adult Grade III Lymphomatoid Granulomatosis Adult Nasal Type Extranodal NK/T-Cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-Cell Lymphoma Ann Arbor Stage I Adult Burkitt Lymphoma Ann Arbor Stage I Adult Hodgkin Lymphoma Ann Arbor Stage I Adult Immunoblastic Lymphoma Ann Arbor Stage I Adult Lymphoblastic Lymphoma Ann Arbor Stage I Adult T-Cell Leukemia/Lymphoma Ann Arbor Stage I Childhood Burkitt Lymphoma Ann Arbor Stage I Childhood Hodgkin Lymphoma Ann Arbor Stage I Childhood Lymphoblastic Lymphoma Ann Arbor Stage I Grade 1 Follicular Lymphoma Ann Arbor Stage I Grade 2 Follicular Lymphoma Ann Arbor Stage I Grade 3 Follicular Lymphoma Ann Arbor Stage I Mantle Cell Lymphoma Ann Arbor Stage I Marginal Zone Lymphoma Ann Arbor Stage I Non-Hodgkin Lymphoma Ann Arbor Stage I Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage I Small Lymphocytic Lymphoma Ann Arbor Stage II Adult Contiguous Immunoblastic Lymphoma Ann Arbor Stage II Adult Hodgkin Lymphoma Ann Arbor Stage II Adult Non-Contiguous Immunoblastic Lymphoma Ann Arbor Stage II Adult T-Cell Leukemia/Lymphoma Ann Arbor Stage II Childhood Burkitt Lymphoma Ann Arbor Stage II Childhood Hodgkin Lymphoma Ann Arbor Stage II Childhood Lymphoblastic Lymphoma Ann Arbor Stage II Contiguous Adult Burkitt Lymphoma Ann Arbor Stage II Contiguous Adult Lymphoblastic Lymphoma Ann Arbor Stage II Contiguous Mantle Cell Lymphoma Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma Ann Arbor Stage II Marginal Zone Lymphoma Ann Arbor Stage II Non-Contiguous Adult Burkitt Lymphoma Ann Arbor Stage II Non-Contiguous Adult Lymphoblastic Lymphoma Ann Arbor Stage II Non-Contiguous Mantle Cell Lymphoma Ann Arbor Stage II Non-Hodgkin Lymphoma Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage II Small Lymphocytic Lymphoma Ann Arbor Stage III Adult Burkitt Lymphoma Ann Arbor Stage III Adult Hodgkin Lymphoma Ann Arbor Stage III Adult Immunoblastic Lymphoma Ann Arbor Stage III Adult Lymphoblastic Lymphoma Ann Arbor Stage III Adult T-Cell Leukemia/Lymphoma Ann Arbor Stage III Childhood Burkitt Lymphoma Ann Arbor Stage III Childhood Hodgkin Lymphoma Ann Arbor Stage III Childhood Lymphoblastic Lymphoma Ann Arbor Stage III Grade 1 Follicular Lymphoma Ann Arbor Stage III Grade 2 Follicular Lymphoma Ann Arbor Stage III Grade 3 Follicular Lymphoma Ann Arbor Stage III Mantle Cell Lymphoma Ann Arbor Stage III Marginal Zone Lymphoma Ann Arbor Stage III Non-Hodgkin Lymphoma Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage III Small Lymphocytic Lymphoma Ann Arbor Stage IV Adult Burkitt Lymphoma Ann Arbor Stage IV Adult Hodgkin Lymphoma Ann Arbor Stage IV Adult Immunoblastic Lymphoma Ann Arbor Stage IV Adult Lymphoblastic Lymphoma Ann Arbor Stage IV Adult T-Cell Leukemia/Lymphoma Ann Arbor Stage IV Childhood Burkitt Lymphoma Ann Arbor Stage IV Childhood Hodgkin Lymphoma Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma Ann Arbor Stage IV Grade 1 Follicular Lymphoma Ann Arbor Stage IV Grade 2 Follicular Lymphoma Ann Arbor Stage IV Grade 3 Follicular Lymphoma Ann Arbor Stage IV Mantle Cell Lymphoma Ann Arbor Stage IV Marginal Zone Lymphoma Ann Arbor Stage IV Non-Hodgkin Lymphoma Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage IV Small Lymphocytic Lymphoma Childhood Burkitt Lymphoma Childhood Grade III Lymphomatoid Granulomatosis Childhood Immunoblastic Lymphoma Childhood Nasal Type Extranodal NK/T-Cell Lymphoma Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Hairy Cell Leukemia Hepatosplenic T-Cell Lymphoma Intraocular Lymphoma Lymphomatous Involvement of Non-Cutaneous Extranodal Site Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Nodal Marginal Zone Lymphoma Non-Hodgkin Lymphoma Primary Cutaneous B-Cell Non-Hodgkin Lymphoma Progressive Hairy Cell Leukemia Initial Treatment Small Intestinal Lymphoma Splenic Marginal Zone Lymphoma Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage I Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage II Chronic Lymphocytic Leukemia Stage II Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage III Chronic Lymphocytic Leukemia Stage III Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IV Chronic Lymphocytic Leukemia Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7 T-Cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia Untreated Hairy Cell Leukemia Waldenstrom Macroglobulinemia Lymphoma Syndrome Leukemia Lymphoma, Follicular Lymphoma, Non-Hodgkin Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, T-Cell Burkitt Lymphoma Mycoses Mycosis Fungoides Sezary Syndrome Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma, B-Cell Lymphoma, Large-Cell, Anaplastic Leukemia, Hairy Cell Lymphomatoid Granulomatosis Lymphoma, Extranodal NK-T-Cell Immunoblastic Lymphadenopathy Leukemia, Large Granular Lymphocytic Plasmablastic Lymphoma Lymphoma, Large-Cell, Immunoblastic Lymphoma, T-Cell, Peripheral Laboratory Biomarker Analysis Questionnaire Administration Ancillary-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 Francisco California 94143 United States
  • UCSF Medical Center-Mission Bay
    San Francisco California 94158 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT01793233
Study Type
Observational
Last Updated
August 3, 2018