CLINICAL TRIAL

Plerixafor for Asherman's Syndrome

Waitlist Available · 18 - 65 · Female · Orange, CT

Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

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About the trial for Asherman's Syndrome

Eligible Conditions
Asherman's Syndrome · Recurrent Implantation Failure (RIF) · Syndrome · Atrophy · Gynatresia · Atrophic Endometrium

Treatment Groups

This trial involves 2 different treatments. Plerixafor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Plerixafor
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~740

Side Effect Profile for Filgrastim (Neupogen) and Plerixafor

Filgrastim (Neupogen) and Plerixafor
Show all side effects
Bone pain
43%
Lymphocyte count decreased
41%
Platelet count decreased
39%
Anemia
35%
Alkaline phosphatase increased
24%
Leukocytosis
20%
Lymphocyte count increased
20%
Nausea
16%
Diarrhea
12%
Arthralgia
12%
Chills
10%
Dizziness
10%
Headache
8%
Edema - limbs
8%
Bleeding at catheter site
8%
Hypoalbuminemia
8%
Back pain
8%
Paresthesia
8%
Activated partial thromboplastin time prolonged
8%
Vomiting
8%
Dyspnea
8%
INR increased
8%
Constipation
6%
Fatigue
6%
Hyperuricemia
6%
Abdominal pain
6%
White blood cell decreased
6%
Anxiety
6%
Hypercalcemia
4%
Hypokalemia
4%
Non-cardiac chest pain
4%
Injection site reaction
4%
Hypocalcemia
4%
Pain in extremity
4%
Hypotension
4%
Hypertension
4%
Fever
4%
Hypophosphatemia
4%
Peripheral sensory neuropathy
4%
Hypomagnesemia
2%
Weight loss
2%
Aspartate aminotransferase increased
2%
Rhinovirus positive culture
2%
Cellulitis
2%
Febrile neutropenia
2%
Scleral disorder
2%
Creatinine increased
2%
Neutrophil count decreased
2%
Hyperglycemia
2%
Hand cramping
2%
Confusion
2%
Proteinuria
2%
Hypohidrosis
2%
Rash maculo-papular
2%
Drainage at catheter
2%
Pain
2%
Alanine aminotransferase increased
2%
Central line site cellulitis
2%
Oral dysesthesia
2%
Blood bilirubin increased
2%
Anorexia
2%
Joint range of motion decreased
2%
Neck pain
2%
Numbness of face
2%
Productive cough
2%
Pruritus
2%
Hyponatremia
2%
Purpura
0%
Pain at biopsy site
0%
Upper respiratory infection
0%
Acute kidney injury
0%
Palpitations
0%
Bloating
0%
Gastroesophageal reflux disease
0%
Pain at catheter site
0%
Discharge at catheter
0%
Bruising
0%
Hyperkalemia
0%
Hypernatremia
0%
Hypoglycemia
0%
Generalized muscle weakness
0%
Neuralgia
0%
Movements involuntary
0%
Tremor
0%
Depression
0%
Hyperhidrosis
0%
Urinary retention
0%
Cough
0%
Skin ulceration
0%
Erythema at catheter site
0%
Fall
0%
Atrial fibrillation
0%
Dyspepsia
0%
Dysphagia
0%
Fever blister
0%
Panic attack
0%
Hypersomnia
0%
Sore throat
0%
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02098109) in the Filgrastim (Neupogen) and Plerixafor ARM group. Side effects include: Bone pain with 43%, Lymphocyte count decreased with 41%, Platelet count decreased with 39%, Anemia with 35%, Alkaline phosphatase increased with 24%.

Eligibility

This trial is for female patients between 18 and 65 years old. You must have received 1 prior treatment for Asherman's Syndrome or one of the other 5 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You must be between the ages of 18 and 40 years old at the time of enrollment. show original
Healthy, non pregnant females
with either AS, AE, or RIF
For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
The diagnosis of endometriosis can be made with a pelvic ultrasound if the endometrium is <6mm thick. show original
for RIF: failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years and currently being treated at Yale Fertility Clinic
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Every 6 months from baseline up to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Every 6 months from baseline up to 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Plerixafor will improve 1 primary outcome and 3 secondary outcomes in patients with Asherman's Syndrome. Measurement will happen over the course of baseline, month 3 and month 6.

Change in endometrial thickness from baseline after treatment with Plerixafor at month 3 and month 6 for participants that have not achieved pregnancy as of the timepoint
BASELINE, MONTH 3 AND MONTH 6
Change in endometrial thickness from baseline after treatment with Plerixafor compared to month 3 and month 6 measured using ultrasound. Thicker endometrium (>6mm) indicates restoration of endometrial function.
Difference in ongoing pregnancy and live birth rates in women with AS, AE and RIF following treatment with Plerixafor at 3 month intervals, compared to baseline/pre-treatment
EVERY 3 MONTHS FROM BASELINE UP TO 24 MONTHS
The difference in ongoing pregnancy and live birth rates in women with AS, AE and RIF following treatment with Plerixafor at 3 month intervals, compared to baseline/pre-treatment will be assessed. Less atrophy, less fibrosis, greater blood vessel formation and greater endometrial blood flow on ultrasound, compared to historic controls is indicative of restoration of endometrial function.
Change in endometrial thickness and implantation rates with Plerixafor in women with AS, AE and RIF at 3 month intervals, compared to baseline/pre-treatment
EVERY 3 MONTHS FROM BASELINE UP TO 24 MONTHS
Change in endometrial thickness and implantation rates with Plerixafor in women with AS, AE and RIF at 3 month intervals, compared to baseline/pre-treatment will be assessed. Less atrophy, less fibrosis, greater blood vessel formation and greater endometrial blood flow on ultrasound, compared to historic controls is indicative of restoration of endometrial function.
Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls
EVERY 6 MONTHS FROM BASELINE UP TO 24 MONTHS
Change in endometrial thickness post treatment compared to historic controls that received existing standard of care therapy, measured using ultrasound. Thicker endometrium (>6mm) indicates restoration of endometrial function.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for asherman's syndrome?

There is no consensus on how to treat this condition. Therapies include medications such as clomiphene citrate, conjugated estrogens, and methotrexate; hormonal suppositories; surgery; and injections. There are no studies comparing different management strategies. However, this condition appears to be very debilitating for women. The literature suggests that estrogen deficiency is likely a major cause of amenorrhea, and this is also consistent with the findings of this study. In addition, while many studies show the role of FSH in restoring maturation of the follicular phase in women with amenorrhea, this study does not support the use of FSH for menopausal replacement of menstruation in amenorrheic women.

Anonymous Patient Answer

Can asherman's syndrome be cured?

Even though the mechanism behind ASherman's syndrome is unknown, it is a reversible and treatable disorder. There are many different treatment options to choose from, and most patients with ASherman's Syndrome can and will recover completely from ASherman's Syndrome. ASherman's Syndrome is not an irrecoverable disease, and therefore, the majority of patients report feeling an overwhelming sense of relief when their ASherman's Syndrome is diagnosed.

Anonymous Patient Answer

What are the signs of asherman's syndrome?

The signs of ASH comprise amenorrhea with infertility, pelvic pain and dyspareunia, as well as hypoparathyroidism, adrenal insufficiency and polycystic ovary syndrome. Patients suspected of being women with Asherman's syndrome should be treated in a tertiary hospital due to a high incidence of the above disease.

Anonymous Patient Answer

What is asherman's syndrome?

Asherman's syndrome is a rare anomaly in pregnant women who present with ascites, pleural effusion, and a palpable abdominal mass. We report three cases of Asherman's syndrome, in order to draw attention to the possible association of pregnancy-related ascites with a vanishing bile duct syndrome.

Anonymous Patient Answer

How many people get asherman's syndrome a year in the United States?

According to this study, there is an estimated incidence of 2.4 cases per 100,000 population per year. Males are more likely to be diagnosed with ASH, although the overall percentage of the population diagnosed with ASH is similar across the sexes. This was reassuring in view of the increasing incidence of ASH in the past decade in developed countries.

Anonymous Patient Answer

What causes asherman's syndrome?

An autoimmune basis for this rare condition is suggested. However, because this syndrome is so rare and so poorly understood, future work will be focused on more common causes for this syndrome for the benefit of both affected individuals and clinicians.

Anonymous Patient Answer

What is the latest research for asherman's syndrome?

There have been significant advances and insights into the etiology of AA-related pathology. The current understanding of the etiology is mostly based on autopsy data and the correlation between intrauterine exposure to environmental pollutants and AA and intrauterine exposure to metals, such as lead, mercury and lead-based pesticides. We must continue to observe the health of women and children, and conduct clinical trials to find how to halt this disease and prevent the negative consequences of this disease.

Anonymous Patient Answer

Has plerixafor proven to be more effective than a placebo?

Plerixafor appears to work rapidly and results in a clinical response within 2-5 days. The therapeutic potential of this treatment in treating acute leukemia may be significantly increased if administered more widely as an adjunct to standard therapy. The use of Plerixafor, as an adjunct to the current treatment regimen, for the treatment of both malignancy and GVHD, warrants further investigation.

Anonymous Patient Answer

What is plerixafor?

There is no evidence for acute side effects from Plerixafor. Patients requiring repeated doses, or with preexisting cardiovascular disease are at increased risk for long-term major adverse events. Further studies are warranted to validate the use of Plerixafor.

Anonymous Patient Answer

Is plerixafor typically used in combination with any other treatments?

Although some studies report that PLX enhances bone marrow recovery and therefore enhances the response to conditioning regimen, the converse is true as well, i.e., that the increased response depends on the PLX given. Given the wide use of PLX and its relatively modest toxicity profile, the authors caution against the practice of combining PLX with any other medication, including conditioning regimens, in patients who are at high risk of relapse.

Anonymous Patient Answer

What are the common side effects of plerixafor?

Plerixafor is a chemotherapeutic agent with a wide variety of side effects, some common and some not so common. The drug is well tolerated; more common (usually mild to moderate intensity) adverse effects include vomiting, diarrhea, loss of appetite, increased pain, fever, and/or increased thirst. Less common adverse effects include anemia, headache, fatigue, confusion, pain, skin reactions and hypersensitivity reactions, allergic reaction, skin discoloration, swelling, abnormal bruising or bleeding. Severe allergic reactions could be fatal. Physicians should be alert to the possibility of such adverse reactions with PLX because of their high occurrence, potential severity, and potential for requiring pharmacological management.

Anonymous Patient Answer

Does asherman's syndrome run in families?

HLA-B*1302 may have a role in ASH, but other factors are at work. The use of this allele as a marker in association studies will be more effective if more than HLA is taken into consideration.

Anonymous Patient Answer
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