Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT02169505
Eligibility Criteria:
Inclusion Criteria:
1. Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days (matched related or matched unrelated donors only).
2. Age 18 to 65 years.
3. Performance status: Zubrod 0-1 or Karnofsky 80-100.
4. Serum creatinine \< 1.5 mg/dL or creatinine clearance greater than or equal to 40 cc/min as defined by MDRD method from National Kidney Disease Education Program (NKDEP).
5. Serum direct bilirubin \< 1.5 mg/dL (unless Gilbert's syndrome).
6. SGPT \< 200 IU/L unless related to patient's malignancy.
7. Evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater to 1000 without growth factor support for at least 5 days.
8. Patients with previous exposure to brentuximab pre-transplant are eligible for the study.
Exclusion Criteria:
1. Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test.
2. Presence of steroid-refractory acute graft-versus-host disease (GVHD).
3. Patients that underwent allogeneic transplantation as a treatment of graft failure.
4. Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02169505
Study Brief:
Protocol Section:
NCT02169505