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Post-transplant Lymphoproliferative DiseasePhase 2NCT01058239

Bortezomib Plus Rituximab for EBV+ PTLD

A Phase 2 study testing bortezomib and rituximab in people with Post-transplant Lymphoproliferative Disease and Solid Organ Transplant, run by Massachusetts General Hospital at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib and rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesUnited States
Study dates
Nov 2011to Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must have had a prior solid organ or allogeneic stem cell transplant.
  • Patients may be newly-diagnosed or relapsed after prior therapy
  • Patients must have histologically confirmed CD20+ B-cell PTLD diagnosed according to WHO criteria. PTLD may be characterized as early lesions, PTLD/polymorphic, PTLD/monomorphic, or PTLD/other, all of which are eligible for this trial. B-cell PTLD must be associated with EBV as demonstrated either by detection of EBV antigens in tumor samples, or by increased EBV quantitative viral load in serum.
  • Patients must have measurable disease
  • 18 years of age or older
  • Estimated life expectancy of > 3 months
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  • ECOG Performance status of 0, 1, or 2
  • Adequate organ and marrow function
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Who cannot join

  • Patients receiving any other study agents. Patients already on prophylactic doses of ganciclovir or valganciclovir because of a prior history of CMV infection or because of risk factors for CMV infection are eligible for the study and may continue CMV prophylaxis.
  • Patients with known brain metastases or central nervous system (CNS) involvement of their lymphoma.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, rituximab, ganciclovir or valgancyclovir.
  • Patients with Grade 2 or greater neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
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  • Pregnant or breastfeeding women
  • Individuals with a history of malignancy are ineligible except for those outlined in the protocol
  • Known HIV positive individuals
  • Active HBV infection may be included only if they are on appropriate anti-hepatitis B therapy and have an undetectable HBV viral load
  • Patient has received other investigational drugs within 14 days before enrollment
  • Prior bortezomib

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Bortezomib Plus Rituximab for EBV + Post Transplant Lymphoproliferative Disease (PTLD)

Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Rituximab is a type of drug called an "antibody" that specifically destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) to treat multiple myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the addition of bortezomib to rituximab treatment can increase the rate of complete remissions and cures of PTLD after organ or stem cell transplant.

Read the detailed description
  • Both rituximab and bortezomib will be given to participants intravenously. Each cycle of treatment will consist of 21 days. Rituximab will be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles. Bortezomib will be given on Days 1, 4, 8 and 11 of every cycle. Participants will receive a maximum of 4 cycles.
  • The following study procedures will be performed during each cycle throughout the study: Medical history review; Physical exam; Performance Status; Questionnaire; Blood draws and; PET/CT scans (After cycles 2, 4 and 6 only).
  • After Cycle 4, if the study doctor feels the participant has had a complete response to treatment, then they will continue onto the Post-Treatment Surveillance period, which will consist of regular clinic visits over two years.
  • However, if the study doctor feels the participant has had a partial response to treatment and that they may benefit from continuing, they will receive an additional two cycles of bortezomib and be given daily tablets of the antiviral drug valganciclovir to help further target EBV.
Being tested
bortezomib, rituximab
Keywords
bortezomib, rituximab, PTLD, EBV, transplantation
Medical subject headings
Epstein-Barr Virus Infections

What participants receive

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

  • bortezomibDrug

    Also called Velcade

    Given intravenously on days 1, 4, 8 and 11 of every cycle

  • rituximabDrug

    Also called Rituxan, Mabthera

    given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles

Study groups in NCT01058239
Study groupRoleWhat they receive
Rituximab plus BortezomibExperimentalThis is a single arm trial adding the new drug bortezomib to the standard drug rituximab
Receives: Drug: bortezomib; Drug: rituximab

What is being measured

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

  1. Overall Response Rate

    Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response. The complete list of criteria used to evaluate response is too long to be detailed in the allotted space here, but response is defined more generally as:

    • Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
    • Partial Response (PR): ≥ 50% decrease in the sum of the products of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.

    Measured: 4 months

Secondary outcomes (5)

  1. Complete Response Rate

    The number of participants with complete responses as assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response.

    Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

    Measured: 4 Months

  2. Six-Month Progression Free Survival

    Percent of participants with progression free survival (alive without disease progression) six months after registration. Progression was evaluated using the International Working Group criteria for lymphoma response.

    > Progressive Disease (PD) or Relapsed Disease (RD):

    1. Appearance of any new lesion > 1.5 cm in any axis during or at end of therapy. Increased Radiolabeled[18F]-2-fluoro-2-deoxy-D-glucose (FDG) uptake in a previously unaffected site will be considered PD/RD only after confirmation by other modalities.
    2. ≥ 50% increase from nadir in the sum of the products of the largest diameters (SPD) of any previously involved node, or in a single involved node, or in the sizes of other lesions.
    3. ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis.
    4. PET (positron emission tomography) positive prior to therapy: post-treatment PET should be positive unless lesion is too small to be detected with current PET sys

    Measured: six months

  3. Overall Survival

    The percent of participants surviving at 6 months and 1 year.

    Measured: 6 months, 1 year

  4. Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load

    The Mean epstein barr virus (EBV) viral load at the given time points.

    Measured: baseline, 21, 42, 63, 84 days (end of cycles 1, 2, 3, 4)

  5. Treatment Related Toxicities

    The toxicities experienced by participants that were deemed to be related to the study treatment. Data is shown as the number of participants that experienced any grade toxicity that was deemed to be related to treatment. Toxicities were assessed with the use of Common Toxicology Criteria for Adverse Events (CTCAE).

    Measured: 2 years

Timeline

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

  1. First posted28 Jan 2010 (estimated)
  2. Study startNov 2011
  3. Primary completionDec 2016
  4. Study completionNov 2017

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01058239
Sponsor's protocol ID
09-346
Other IDs
X05289
Status last verified
Jan 2018
First submitted
26 Jan 2010
Last updated
15 Feb 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib and rituximab in people with Post-transplant Lymphoproliferative Disease and Solid Organ Transplant, run by Massachusetts General Hospital at 3 sites in United States.

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 9 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: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 15 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: 4 months). 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 NCT01058239.

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 15 Feb 2018.

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