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.
Brief Title
Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Anaplastic Large Cell Lymphoma
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Hodgkin Lymphoma
Lymphoma
Eligibility 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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
29 Years
NCT Id
NCT01793233
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
ALTE11C1
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
Primary Outcomes
Outcome Description
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.
Outcome Measure
Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls
Outcome Time Frame
Up to 12 months
Outcome Description
Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
Outcome Measure
Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline
Outcome Time Frame
Baseline up to end of chemotherapy
Outcome Description
Generalized estimating equation (GEE) will be used to model the change as a function of time.
Outcome Measure
Degree of recovery of AMH, FSH, and E2 in the post-therapy phase
Outcome Time Frame
Up to 12 months
Secondary Ids
Secondary Id
NCI-2013-00069
Secondary Id
ALTE11C1
Secondary Id
COG-ALTE11C1
Secondary Id
ALTE11C1
Secondary Id
U10CA095861
Secondary Id
UG1CA189955
Secondary Outcomes
Outcome Description
Describe the number of patients with AOF as measured at 12 months by an FSH \> 40 divided by the total population.
Outcome Time Frame
Up to 12 months
Outcome Measure
Rate of AOF
Outcome Description
Describe the number of samples collected.
Outcome Time Frame
At enrollment (or diagnosis) and Day 5 post enrollment
Outcome Measure
Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients with newly diagnosed lymphoma at Children's Oncology Group
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
29
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alice Lee
Investigator Email
alee5@montefiore.org