Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD)

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Withdrawn

Phase 2

Conditions

PTLD

Post-transplant Lymphoproliferative Disorder

Treatments

Drug: Obinutuzumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03086395

CASE8Z15

Details and patient eligibility

About

Patients with post transplant lymphoproliferative disorder (PTLD) that have been treated with at least one type of chemotherapy, but whose lymphoma is not responding or coming back after the previous treatment will be asked to participate in this study.

This clinical trial uses a drug called Obinutuzumab. The Food and Drug Administration (FDA) has approved Obinutuzumab for sale in the United States for certain diseases. Obinutuzumab is still being studied in clinical trials to learn more about what its side effects are and whether or not it is effective in the disease or condition being studied. Obinutuzumab is considered an investigational drug in this study

Obinutuzumab (GA101) is an antibody directed against cluster of differentiation antigen 20 (CD20). Antibodies are protein that are part of the immune system that can target cancer cells. Obinutuzumab sticks to a target called CD20. CD20 is an important molecule on some cancer cells (including non-Hodgkin lymphoma) and some normal cells of the immune system.

This study is being done to test if the study drug has an effect on post transplant lymphoproliferative disorder and to see how lymphoma will respond to the study drug.

Full description

Primary Objective:

• To determine the overall response rate of obinutuzumab in relapsed/refractory post-transplant lymphoproliferative disorder (PTLD) in both solid organ transplant (SOT) and bone marrow transplant (BMT) patients

Secondary Objectives:

Complete remission (CR) rate
Duration of response (DOR)
Progression free survival (PFS)
Overall survival (OS)
Time to treatment failure (TTF)
Safety and tolerability of obinutuzumab

Patient Population:

Relapsed or refractory post-transplant lymphoproliferative disorder (PTLD) patients who have received at least one prior therapy

Study Design:

Phase II study of single agent obinutuzumab in relapsed/refractory (RR) post-transplant lymphoproliferative disorder (PTLD) in both SOT and BMT patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed relapsed/refractory post-transplant lymphoproliferative disorder
Relapsed/refractory disease with at least 1 prior chemotherapy regimen
Measurable disease ≥1.5 cm
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG 3 will be permitted if the decline in the performance status is attributed to the lymphoma
Able to sign the consent form
Adequate organ function
- bilirubin ≤1.5 times upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN or ≤5 times ULN for patients with document hepatic involvement with lymphoma
- serum creatinine clearance >50 ml/min
- absolute neutrophil count (ANC) ≥500/μL (unless documented bone marrow involvement with lymphoma)
- hemoglobin >8 gm/dl
- platelet count ≥50,000/μL (unless documented bone marrow involvement with lymphoma)

Exclusion criteria

Prior treatment with obinutuzumab
Pregnancy or breast feeding women
Current active malignancy other than PTLD, requiring active treatment
Presence of central nervous system (CNS) involvement
HIV positive patients
Myocardial infarction within the past 6 months
Patients with the following medical conditions that could affect their participation in the study:
- any active acute or chronic or uncontrolled infection
- liver disease including history of viral hepatitis B or C, evidence of cirrhosis, chronic active or persistent hepatitis
- a known history of HIV
- symptomatic cardiac disease, including congestive heart failure, coronary artery disease, and arrhythmias
Current therapy with chemotherapy or investigational agents within 4 weeks of start of study treatment