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TerminatedNCT00869323Updated Dec 5, 2017Results posted

Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders

A Phase 2 interventional study of rituximab and bortezomib in Lymphoproliferative Disorder, sponsored by Masonic Cancer Center, University of Minnesota. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment

Why this study was terminated
Funding unavailable
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.

Read the detailed description

OBJECTIVES:

Primary

  • To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.

Secondary

  • To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients.
  • To characterize the quantitative and qualitative toxicities of this regimen.

OUTLINE:

  • Induction therapy: Patients receive bortezomib intravenously (IV) and rituximab IV on days 1, 8, 15, and 22.

Patients achieving complete remission (CR) after completion of induction therapy proceed to maintenance therapy after 6 months of rest. Patients achieving partial remission (PR) or stable disease after completion of induction therapy receive additional bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/PR after completion of bortezomib therapy proceed to maintenance therapy after 3 months of rest.

  • Maintenance therapy: Patients receive bortezomib IV and rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years.

02

Conditions studied

  • Lymphoproliferative Disorder

Keywords

  • post-transplant lymphoproliferative disorder
03

In context

Lymphoproliferative Disorders

231 studies on the registry are indexed under Lymphoproliferative Disorders; 45 are open to participants now.

This study's enrollment of 3 is below the median of 41 across 179 interventional studies indexed under Lymphoproliferative Disorders.

Browse Lymphoproliferative Disorders studies →

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed CD20+ B-cell post-transplant lymphoproliferative disorder
  • Has undergone prior solid organ transplant
  • Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
  • Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal
  • Total bilirubin ≤ 2.0 mg/dL

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Peripheral neuropathy ≥ grade 2
  • Known lymphomatous meningitis or central nervous system (CNS) involvement
  • HIV infection
  • Uncontrolled infection
  • Myocardial infarction within the past 6 months or uncontrolled angina
  • New York Heart Association class III-IV heart failure
  • Severe uncontrolled ventricular arrhythmias
  • Evidence of acute ischemia or active conduction system abnormalities by electrocardiogram (EKG)
  • Concurrent serious medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • Diagnosis or treatment for another malignancy within the past 3 years, except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
  • Known hypersensitivity to rituximab, bortezomib, boron, or any of the other agents used in this study
  • Less than 14 days since prior investigational drugs
  • Less than 4 weeks since prior bortezomib therapy (12 weeks for rituximab) and recovered from toxic effects prior to enrollment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Treated Patients

    This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).

    Biological: rituximab · Drug: bortezomib

Interventions

  • Biologicalrituximab

    375 mg/m\^2 intravenously on Days 1,8, 15 and 22

    Also known as: Rituxan

  • Drugbortezomib

    1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22

    Also known as: Velcade

06

What researchers measure

Primary outcomes

  1. Number of Patients With Overall (Complete and Partial) Response Rates

    Time frame: Day 1 to 2 Years Post Treatment

Secondary outcomes

  1. Remission Duration Among Patients Who Respond to Treatment

    Time frame: Day 1 to 8 Months Post Treatment

  2. Time to Treatment Failure

    Time frame: Day 1 to Time of Disease Progression

  3. Relapse-free Survival

    Time frame: at 2 years

  4. Overall Survival

    Time frame: at 2 years

07

Results

Posted Apr 5, 2017

Participant flow

Induction Therapy
Participant flow — Induction Therapy
MilestoneTreated Study Participants
Started3
Completed3
Not completed0
Maintenance Therapy
Participant flow — Maintenance Therapy
MilestoneTreated Study Participants
Started2
Completed1
Not completed1
Withdrew: Concurrent illness1

Outcome measures

PrimaryNumber of Patients With Overall (Complete and Partial) Response Rates
Time frame:
Day 1 to 2 Years Post Treatment
Reported as:
Number · participants
Number of Patients With Overall (Complete and Partial) Response Rates
participantsTreated Study Participants
Number of Patients With Overall (Complete and Partial) Response Rates2
SecondaryRemission Duration Among Patients Who Respond to Treatment
Time frame:
Day 1 to 8 Months Post Treatment
Reported as:
Median · months
Remission Duration Among Patients Who Respond to Treatment
monthsTreated Study Participants
Remission Duration Among Patients Who Respond to Treatment45 (22 to 68)
SecondaryTime to Treatment Failure
Time frame:
Day 1 to Time of Disease Progression
Reported as:
Number · months
Time to Treatment Failure
monthsTreated Study Participants
Time to Treatment Failure1
SecondaryRelapse-free Survival
Time frame:
at 2 years
Reported as:
Number · participants
Relapse-free Survival
participantsTreated Study Participants
Relapse-free Survival2
SecondaryOverall Survival
Time frame:
at 2 years
Reported as:
Number · participants
Overall Survival
participantsTreated Study Participants
Overall Survival1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treated Study Participants—2/3 (66.7%)3/3 (100%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventTreated Study Participants
FeverGeneral disorders1/3
Urinary tract infectionInfections and infestations1/3
Renal failureRenal and urinary disorders1/3
Pain in extremityMusculoskeletal and connective tissue disorders1/3
HypertensionVascular disorders1/3
MyoclonusMusculoskeletal and connective tissue disorders1/3
ConfusionNervous system disorders1/3
Neuropathic painNervous system disorders1/3
PsychosisNervous system disorders1/3
AnemiaBlood and lymphatic system disorders1/3
Most frequent other events
Showing 10 of 19
Most frequent other events
EventTreated Study Participants
AnemiaBlood and lymphatic system disorders2/3
Aspartate aminotransferase increasedInvestigations1/3
Alanine aminotransferase increasedInvestigations1/3
FeverGeneral disorders1/3
DehydrationGastrointestinal disorders1/3
HypercalcemiaMetabolism and nutrition disorders1/3
MyoclonusMusculoskeletal and connective tissue disorders1/3
ConfusionNervous system disorders1/3
Neuropathic painNervous system disorders1/3
PsychosisNervous system disorders1/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treated Study Participants
<=18 years0
Between 18 and 65 years2
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Treated Study Participants
Female2
Male1
08

Study locations

2 sites
  • University of Minnesota Medical Center - Fairview
    Minneapolis, Minnesota 55455, United States
  • Washington University School of Medicine - Oncology Division
    Saint Louis, Missouri 63110, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00869323
Lead sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Millennium Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Mar 26, 2009
Start date
Mar 2009
Primary completion
Mar 2013
Completion
Dec 2016
Results posted
Apr 5, 2017
Last update
Dec 5, 2017

Study contacts

Anne H. Blaes, MD
principal investigator · Masonic Cancer Center, University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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