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

NCT03086395 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CASE8Z15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-transplant Lymphoproliferative Disorder; PTLD

Keywords

relapsed; refractory

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate will be estimated by the total number of patients who achieve a CR and PR divided by the total number of evaluable patients. Response will be assessed using CT scans according to the revised Cheson criteria * CR is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy * PR is defined as at least 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses

  Up to 36 months after beginning treatment

Secondary Outcomes (5)

• Complete Response Rate

  Up to 36 months after beginning treatment

• Progression Free Survival

  Up to 36 months after beginning treatment

• Overall Survival

  Up to 36 months after beginning treatment

• Duration of Response

  Up to 36 months after beginning treatment

• Time to Treatment Failure

  Up to 36 months after beginning treatment

Study Arms (1)

Obinutuzumab

EXPERIMENTAL

Patients will be treated with a total of 2 cycles of obinutuzumab.

Drug: Obinutuzumab

Interventions

Obinutuzumab DRUG

Patients will be treated with a total of 2 cycles of obinutuzumab. Cycle 1 obinutuzumab dose is 1000 mg given intravenously (IV) on day 1, 8, 15. Cycle #1 day #1 dose of 1000 mg of obinutuzumab will be administered over 2 days. During Cycle 1, Day 1, 100 mg will be administered. On the following day (Cycle 1, Day 2), 900 mg will be administered. During cycle 2 patients will receive a single dose of obinutuzumab1000 mg IV on day 1. Cycle #2 will be given 21 days after the first cycle.

Also known as: Gazyva

Obinutuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Recurrence

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deepa Jagadeesh, MD, MPH

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2021
• Last Updated: March 22, 2017

Record last verified: 2017-03