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Follicular LymphomaPhase 1/2NCT01460602

Velcade, Nipent, Rituxan (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma

A Phase 1/2 study testing MTD of Velcade, Nipent and Rituxan established in Part 1 in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
MTD of Velcade, Nipent and Rituxan established in Part 1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2010to Oct 2014
Phase
Phase 1/2
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent.
  • Male or female subject 18 years of age and older
  • Karnofsky Performance Status (KPS) score of 50%. ECOG Performance Status score greater than 2.
  • Histologically confirmed follicular Grade 1-3a, marginal zone or mantle cell NHL.
  • Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
  • Bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension
Show all 10Show fewer
  • Hematologic, hepatic, and renal function parameters.
  • Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
  • Expected survival of 3 months
  • Accepted birth control methods during treatment and for 12 months after completion of treatment.

Who cannot join

  • Follicular lymphoma Grade 3b
  • History of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations
  • Grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment
  • Serum creatinine 2.5 mg/dL within 14 days before enrollment.
  • Absolute neutrophil count (ANC) < 1,000/L, platelet count < 70,000/L within 14 days before enrollment
  • Aspartate transaminase (AST [SGOT]) and alanine transaminase (ALT/SGPT]) > 2 x the upper limit of normal (ULN), total bilirubin > 3 ULN
Show all 23Show fewer
  • Rituxan refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior Rituxan or prior Rituxan-containing regimen, or a response with a TTP of less than 6 months)
  • Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosurea or mytomycin-C)
  • Prior lymphoma vaccine therapy within 12 months to Study Day 1
  • Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1
  • Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1
  • Known history of hepatitis or hepatic disease.
  • Presence of central nervous system (CNS) lymphoma
  • Known history of HIV infection or AIDS
  • Histologic transformation (Follicular or Marginal zone to diffuse large B cell lymphoma [DLBCL]
  • Presence of pleural or peritoneal effusion with positive cytology for lymphoma
  • Another primary malignancy requiring active treatment
  • Serious non-malignant disease (e.g., congestive heart failure [CHF], hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions (including psychiatric), which would compromise protocol objectives n the opinion of the Investigator and/or Sponsor
  • New York Heart Association Class III or IV (Appendix D) cardiac disease
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
  • Female subject who is pregnant or currently breast-feeding
  • Received other investigational drugs with 14 days before enrollment
  • Hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LSU - Shreveport Health Sciences Center, Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

Other trials in United States

About this study

Official title: Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma

This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma.

Read the detailed description

Number of Subjects: During the Phase 1 part of the study as many as 15 subjects may be enrolled, based on the dose escalation scheme; the actual number of subjects enrolled will depend on the dose level at which the maximum tolerated dose (MTD) is established.

During the Phase 2 part of the study, approximately 15 subjects will be enrolled in order to obtain a total 30 response-evaluable subjects.

Study Objectives:

The primary objectives of this study are:

  • Assess the CR and ORR following treatment with VELCADE (bortezomib), Nipent (pentostatin) and Rituxan (rituximab) (VNR) in subjects with follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) who have relapsed or been refractory after receiving at least 1 prior therapy.

The secondary objectives of this study are to:

  • Determine the MTD of VELCADE and Nipent in combination with Rituxan (VNR) in subjects with follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) who have relapsed or been refractory after receiving at least 1 prior therapy
  • Evaluate the safety and tolerability of VNR
  • Determine the time to response
  • Determine duration of response
  • Determine the time to progression (TTP)
  • Determine the progression free survival (PFS) rate
  • Determine the 1-year survival
  • Determine overall survival (OS)
Being tested
MTD of Velcade, Nipent and Rituxan established in Part 1
Keywords
Lymphoma, Follicular, Marginal Zone, Mantle Cell, Velcade, bortezomib, Nipent, pentastatin, Rituxan, rituximab, Turturro, Shreveport
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Lymphoma

What participants receive

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

  • MTD of Velcade, Nipent and Rituxan established in Part 1Drug

    One of the following dose levels will be chosen and used in Part 2:

    1. (VAN1) VA= 1.3 mg/m2 IV Days 1, 4, 8, 11 N1= 2 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
    2. (VAN2) VA= 1.3 mg/m2 IV Days 1, 4, 8, 11 N1= 4 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
    3. (VBN1) VA= 1.5 mg/m2 IV Days 1, 4, 8, 11 N1= 2 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
    4. (VBN2) VA= 1.5 mg/m2 IV Days 1, 4, 8, 11 N1= 4 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
Study groups in NCT01460602
Study groupRoleWhat they receive
Part 1: establish MTDExperimentalPart 1 consists of dosing to determine maximum tolerated dose (MTD) and dose limiting toxicity (DLT).
Receives: Drug: MTD of Velcade, Nipent and Rituxan established in Part 1
Part 2: The MTD from Part 1ExperimentalDuring the Phase 2 part of the study, approximately 24 additional subjects will be enrolled in order to obtain a total of 30 response-evaluable subjects treated at the maximum tolerated dose.
Receives: Drug: MTD of Velcade, Nipent and Rituxan established in Part 1

What is being measured

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

  1. CR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapy

    Study Days 1, 4, 8, 11 of 6 cycles (up to 3 weeks each) and Days 63/126, then Study Months 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48

    Measured: up to 48 months

  2. ORR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapy

    Study Days 1, 4, 8, 11 of 6 cycles (up to 3 weeks each) and Days 63/126, then Study Months 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48

    Measured: up to 48 months

Secondary outcomes (2)

  1. Maximum Tolerated Dose

    Number of participants with adverse events as a measure of safety and tolerability

    Measured: Study Days 1, 4, 8, 11 of 6 cycles (up to 3 weeks each) and Days 63/126, then Study Months 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48

  2. Rate of progression of disease

    Summary data on time to progression of disease of study subjects

    Measured: Study Days 1, 4, 8, 11 of 6 cycles (up to 3 weeks each) and Days 63/126, then Study Months 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48

Timeline

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

  1. First posted27 Oct 2011 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2014
  4. Study completionOct 2014

Why it stopped: Investigator has relocated to MD Anderson

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460602
Sponsor's protocol ID
X05266
Status last verified
Jul 2020
First submitted
10 Jun 2010
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MTD of Velcade, Nipent and Rituxan established in Part 1 in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Louisiana State University Health Sciences Center Shreveport at 1 site 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 10 inclusion and 23 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

CR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapy (time frame: up to 48 months). The study lists 2 primary outcomes in all. 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 NCT01460602.

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 1 Sep 2020.

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