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Post-transplant Lymphoproliferative DisorderPhase 2NCT03086395

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

A Phase 2 study testing Obinutuzumab in people with Post-transplant Lymphoproliferative Disorder and PTLD, run by Case Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Apr 2017to 1 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

About this study

Official title: Phase II Study of Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD)

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

Read more

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.

Read the detailed 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

Being tested
Obinutuzumab
Keywords
relapsed, refractory
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called Gazyva

    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.

Study groups in NCT03086395
Study groupRoleWhat they receive
ObinutuzumabExperimentalPatients will be treated with a total of 2 cycles of obinutuzumab.
Receives: Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 36 months after beginning treatment

Secondary outcomes (5)

  1. Complete Response Rate

    CR is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy. A post-treatment residual mass of any size is permitted as long as it is proton emission tomography (PET) negative. CR rate will be calculated by dividing the dividing the total number of patients who have achieved CR by the total number of patients who have achieved a CR and PR.

    Measured: Up to 36 months after beginning treatment

  2. Progression Free Survival

    Progression-free survival (PFS) is defined as the time from enrollment into the study to disease progression or death due to any cause. It may be defined as the date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed.

    Measured: Up to 36 months after beginning treatment

  3. Overall Survival

    The OS is defined as the time from enrollment to the time of death due to any cause. For a patient who is alive at the end of study follow-up, observation of OS is censored on the date of last contact.

    Measured: Up to 36 months after beginning treatment

  4. Duration of Response

    Duration of response (DOR) is defined as the time from first documentation of objective tumor response (CR or PR) to the time to tumor progression or death due to any cause.

    Measured: Up to 36 months after beginning treatment

  5. Time to Treatment Failure

    Time to treatment failure (TTF) is defined as the time from enrollment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

    Measured: Up to 36 months after beginning treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study start1 Apr 2017 (estimated)
  3. Primary completion1 Jan 2018 (estimated)
  4. Study completion1 Jan 2021 (estimated)

Why it stopped: Funding Unavailable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086395
Sponsor's protocol ID
CASE8Z15
Status last verified
Mar 2017
First submitted
16 Mar 2017
Last updated
22 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab in people with Post-transplant Lymphoproliferative Disorder and PTLD, run by Case Comprehensive Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 36 months after beginning treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03086395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.

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