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Compares treatment options for Graft Vs Host Disease
Official title Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
ClinicalTrials.gov ID: NCT04380740
What this study is testing
What is Abatacept?
Abatacept is an investigational medicine, being studied as a potential treatment for graft vs host disease.
Also referred to as orencia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Must be at least 2 years old and weigh 10 kg.
- Must have a willing unrelated adult donor (bone marrow or peripheral blood). Donors may have a single mismatch (i.e. be a 7/8) and this mismatch may...
- All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to...
- Must have a hematologic malignancy treatable by HCT (except for those stipulated below under study
You likely can't join if
- ), which is in remission by standard testing (no patients in relapse will be included).
- Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to...
- Karnofsky performance score or Lanskey Play-Performance Scale score \>/= 80.
- If the patient does not meet defined eligibility requirements, the PI/study committee must be contacted to determine eligibility. Exclusion Criteria:
- Patients with the following hematologic malignancies will be excluded: Chronic Lymphocytic Leukemia, Myeloma and Primary Myelofibrosis.
- Active Relapse (\>5% blasts) of their primary malignancy.
See the full eligibility criteria
- Must be at least 2 years old and weigh 10 kg.
- Must have a willing unrelated adult donor (bone marrow or peripheral blood). Donors may have a single mismatch (i.e. be a 7/8) and this mismatch may be at the allele or antigen level; however, donors with allele level...
- All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- Must have a hematologic malignancy treatable by HCT (except for those stipulated below under study
- ), which is in remission by standard testing (no patients in relapse will be included).
- Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to transplant morbidities or non-hematologic cancers.
- Karnofsky performance score or Lanskey Play-Performance Scale score \>/= 80.
- If the patient does not meet defined eligibility requirements, the PI/study committee must be contacted to determine eligibility. Exclusion Criteria:
- Patients with the following hematologic malignancies will be excluded: Chronic Lymphocytic Leukemia, Myeloma and Primary Myelofibrosis.
- Active Relapse (\>5% blasts) of their primary malignancy.
- For patients with Acute Lymphocytic Leukemia (ALL) with pre-transplant MRD testing performed as standard practice at the treating institution, patients with MRD \>0.01% will be ineligible.
- For patients with Acute Myeloid Leukemia (AML) with pre-transplant MRD testing as standard of practice at the treating institution, patients with any MRD status are eligible and should be enrolled at the discretion of...
- For patients with MDS, those with \>5% blasts will be excluded.
- Prior allogeneic HCT.
- Uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment.
- HIV infection.
- Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression.
- Prisoners or others who are compulsorily detained.
- Any patient with a known or suspected inherited predisposition to cancer should be discussed with the study team prior to screening for eligibility.
- Patients with a known inherited or constitutional predisposition to transplant morbidities, including, but not limited to Fanconi Anemia, Dyskeratosis Congenita, Shwachman-Diamond Syndrome and Down Syndrome will be...
- Patients with known inherited or constitutional predisposition to non-hematologic cancers including, but not limited to Li-Fraumeni syndrome, BRCA1 and BRCA2 mutations will be excluded.
- Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease...
- Incompletely treated active tuberculosis Infection.
- Pregnancy (positive serum b-HCG) or breastfeeding.
- Estimated GFR of \< 50 mL/min/1.73m2.
- Cardiac ejection fraction \< 50 (using M-Mode if assessment is done by ECHO)
- T.bilirubin \> 2 × upper limit of normal or ALT \> 4 × upper limit of normal or unresolved veno-occlusive disease.
- Pulmonary disease with FVC, FEV1 or DLCO parameters \<45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be...
- Presence of antibodies to a mismatched donor HLA antigen (please refer to Section 3.4.g).
- Patients who have developed severe AGVHD, severe CGVHD or relapse will be excluded at the time of randomization.
- Exclusion Criteria Prior to Randomization (prior to 5th dose of abatacept/placebo):
- Severe allergic reaction during the first 4 doses of abatacept
- If any clinical events occur that preclude further dosing of abatacept, those patients will be deemed ineligible for randomization
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Rochester, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.