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

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ClinicalTrials.gov Identifier: NCT01793233
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

Condition or disease Intervention/treatment
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 Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.


Study Type : Observational
Estimated Enrollment : 205 participants
Official Title: Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
Actual Study Start Date : June 17, 2013
Estimated Primary Completion Date : June 30, 2019


Group/Cohort Intervention/treatment
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.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls [ Time Frame: Up to 12 months ]
    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.


Secondary Outcome Measures :
  1. Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline [ Time Frame: Baseline up to end of chemotherapy ]
    Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.

  2. Degree of recovery of AMH, FSH, and E2 in the post-therapy phase [ Time Frame: Up to 12 months ]
    Generalized estimating equation (GEE) will be used to model the change as a function of time.

  3. Rate of AOF [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793233


  Show 107 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jennifer Levine Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01793233     History of Changes
Other Study ID Numbers: ALTE11C1
NCI-2013-00069 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ALTE11C1 ( Other Identifier: Childrens Oncology Group )
COG-ALTE11C1 ( Other Identifier: DCP )
ALTE11C1 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
Lymphoma, Large-Cell, Anaplastic
Leukemia, Hairy Cell
Lymphomatoid Granulomatosis
Lymphoma, Extranodal NK-T-Cell
Immunoblastic Lymphadenopathy
Intraocular Lymphoma
Leukemia, Large Granular Lymphocytic
Plasmablastic Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, T-Cell, Peripheral