Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)

• Status: Terminated
• Trial end date: 2017-08-14
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab vedotin can help to prevent the disease from coming back.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin

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.