LymphomaPhase 1/2NCT00290706

A Phase I/II Trial of VELCADE & Gemcitabine for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma

A Phase 1/2 study testing bortezomib and gemcitabine hydrochloride in people with Lymphoma, run by Northwestern University at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma
What is being tested?: bortezomib and gemcitabine hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 3 sitesUnited States
Study dates: 7 Apr 2006to 5 Sep 2012
Phase: Phase 1/2
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

DISEASE CHARACTERISTICS:

Diagnosis of B- or T-cell non-Hodgkin's lymphoma (NHL)
Intermediate histology B-cell NHL, including any of the following:
Diffuse large B-cell lymphoma
Transformed large cell lymphoma
Any T-cell NHL histology
Cutaneous T-cell lymphoma (CTCL) or mycosis fungoides (MF) allowed
Relapsed or refractory disease, defined as disease progressed after prior complete remission (CR), partial remission (PR), or stable disease (SD) to last therapy OR failure to achieve CR, PR, or SD after completion of last therapy
Must have received 1-3 prior therapeutic regimens
Cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) AND cyclophosphamide, vincristine, and prednisone (CVP) OR CHOP with rituximab (CHOP-R) AND CVP with rituximab (CVP-R) is considered 1 regimen
Monoclonal antibody (e.g., rituximab) given as maintenance therapy is considered 1 regimen
Salvage chemotherapy followed by an autologous stem cell transplant is considered 1 regimen
No more than 7 prior therapeutic regimens for patients with CTCL or MF
No mantle cell lymphoma

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 3 months
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
At least 50,000/mm^3 if documented bone marrow involvement
Hemoglobin ≥ 8.0 g/dL
AST and ALT ≤ 3 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN
Bilirubin ≤ 2 times ULN
Creatinine ≤ 2.0 mg/dL
No known history of HIV infection
No other active infection
No uncontrolled hypertension
No peripheral neuropathy ≥ grade 2 within the past 2 weeks
No myocardial infarction within the past 6 months
No New York Heart Association class III or IV heart failure
No uncontrolled angina
No severe uncontrolled ventricular arrhythmias
No acute ischemia or active conduction system abnormalities by ECG
No hypersensitivity to bortezomib, boron, or mannitol
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier-method contraception
No serious medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Prior autologous and/or allogeneic stem cell transplantation allowed
More than 3 weeks since prior chemotherapy, radiotherapy, or immunotherapy
More than 3 weeks since prior systemic biologic anticancer therapy
More than 3 weeks since prior systemic corticosteroids (e.g., oral prednisone > 10 mg per day)
More than 2 weeks since prior investigational drug
No prior bortezomib or gemcitabine hydrochloride
No other concurrent systemic cytotoxic chemotherapy or investigational agents

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Northwestern University
Chicago, Illinois, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
University of Chicago Cancer Research Center
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: A Phase I/II Trial of Combination Bortezomib (VELCADE) and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma

PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with gemcitabine and to see how well they work in treating patients with relapsed or refractory B-cell or T-cell non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

Determine the response rate (complete and partial remission) in patients with relapsed or refractory aggressive B- or T-cell non-Hodgkin's lymphoma treated with gemcitabine hydrochloride and bortezomib.
Determine the maximum tolerated dose of bortezomib when administered with gemcitabine hydrochloride in these patients.

Secondary

Determine the time to treatment failure, duration of response, and overall survival of patients treated with this regimen.
Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II, open-label study.

Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity (DLT) OR the dose that at which 2 of 6 patients experience DLT.

Phase II: Patients receive gemcitabine hydrochloride and bortezomib as in phase I at the MTD.

After completion of study therapy, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Conditions: Lymphoma
Being tested: bortezomib, gemcitabine hydrochloride
Keywords: recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent mycosis fungoides/Sezary syndrome
Medical subject headings: Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides

What participants receive

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

bortezomibDrug
Also called Velcade®, PS-341
Bortezomib 1.6mg/m2 on days 1 and 15 of each cycle, given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.
gemcitabine hydrochlorideDrug
Also called Gemzar®
Gemcitabine dose of 800 mg/m2 over 30 minutes on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.

Study groups in NCT00290706
Study group	Role	What they receive
Gemcitabine 800 mg/m2 + Bortezomib IVP over 3-5 seconds	Experimental	Gemcitabine dose of 800 mg/m2 over 30 minutes followed by Bortezomib IVP given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles. Receives: Drug: bortezomib; Drug: gemcitabine hydrochloride

What is being measured

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

Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.
Response rate in patients with relapsed or refractory B- and T-cell NHL with Gemcitabine and Bortezomib combination treatment will be defined as the number of patients with Complete Remission [CR] and Partial Remission [PR]. CT scans at screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8 assessed by the Response Criteria for Non-hodgkins Lymphoma will be used to determine response where:
CR=Complete disappearance of all detectable clinical and radiographic evidence of disease PR=> 50% decrease in SPD of the six largest dominant nodes or nodal masses
Measured: At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8

Secondary outcomes (3)

Time to Treatment Failure and Duration of Response
Time to treatment failure and duration of response will be measured by CT Scan at screening and after completing cycle 3, cycle 6 and 30 days after cycle 8, then every 6 months for 3 years
Measured: At screening and after completing cycle 3, cycle 6 and 30 days after cycle 8, then every 6 months for 3 years
Overall Survival
Overall survival will be evaluated every 6 months while on treatment and then every 6 months while off of treatment for up to 3 years
Measured: Every 6 months while on treatment and then every 6 months while off of treatment for up to 3 years
Evaluate Safety and Tolerability of Bortezomib and Gemcitabine Therapy
Safety and tolerability of the study drugs will be assessed on Day 1 and on either Day 8 or Day 15 of each treatment cycle (1 Cycle - 28 days) while on active treatment; and 30 days post last treatment. Adverse Events that are experienced by patients, determined to be either grade 3 or grade 4 and at least possibly related to at least one of the study drugs as assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) will be collected. In general adverse events (AEs) will be graded according to the following:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Measured: During treatment through a maximum of 8 Cycles (1 Cycle = 28 Days) and 30 days post last treatment

Timeline

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

7 Apr 20065 Sep 2012

First posted13 Feb 2006 (estimated)
Study start7 Apr 2006
Primary completion11 Feb 2011
Study completion5 Sep 2012

Why it stopped: Closed per Data Monitoring Committee due to lack of efficacy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphomaStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00290706
Sponsor's protocol ID: NU 04H4
Other IDs: NU 04H4, VEL-03-082, STU00007425
Status last verified: May 2019
First submitted: 9 Feb 2006
Last updated: 28 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Trial of Combination Bortezomib (VELCADE) and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT00290706
Acronym / sponsor ID: NU 04H4
Conditions: Lymphoma
Keywords: recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent mycosis fungoides/Sezary syndrome
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Closed per Data Monitoring Committee due to lack of efficacy
Enrolment: 32 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Eli Lilly and Company, Millennium Pharmaceuticals, Inc.
Study start: 7 Apr 2006 (actual)
Primary completion: 11 Feb 2011 (actual)
Study completion: 5 Sep 2012 (actual)
First posted: 13 Feb 2006 (estimated)
Results: Posted 28 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

Determine the response rate (complete and partial remission) in patients with relapsed or refractory aggressive B- or T-cell non-Hodgkin's lymphoma treated with gemcitabine hydrochloride and bortezomib.
Determine the maximum tolerated dose of bortezomib when administered with gemcitabine hydrochloride in these patients.

Secondary

Determine the time to treatment failure, duration of response, and overall survival of patients treated with this regimen.
Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II, open-label study.

Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Phase II: Patients receive gemcitabine hydrochloride and bortezomib as in phase I at the MTD.

After completion of study therapy, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gemcitabine 800 mg/m2 + Bortezomib IVP over 3-5 seconds	Experimental	Drug: bortezomib, Drug: gemcitabine hydrochlorideGemcitabine dose of 800 mg/m2 over 30 minutes followed by Bortezomib IVP given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bortezomibAlso: Velcade®, PS-341Bortezomib 1.6mg/m2 on days 1 and 15 of each cycle, given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.	Drug	Gemcitabine 800 mg/m2 + Bortezomib IVP over 3-5 seconds
gemcitabine hydrochlorideAlso: Gemzar®Gemcitabine dose of 800 mg/m2 over 30 minutes on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.	Drug	Gemcitabine 800 mg/m2 + Bortezomib IVP over 3-5 seconds

Primary outcome

Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.
Time frame: At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8
Response rate in patients with relapsed or refractory B- and T-cell NHL with Gemcitabine and Bortezomib combination treatment will be defined as the number of patients with Complete Remission [CR] and Partial Remission [PR]. CT scans at screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8 assessed by the Response Criteria for Non-hodgkins Lymphoma will be used to determine response where: CR=Complete disappearance of all detectable clinical and radiographic evidence of disease PR=> 50% decrease in SPD of the six largest dominant nodes or nodal masses

3 secondary outcomes

Time to Treatment Failure and Duration of Response
Time frame: At screening and after completing cycle 3, cycle 6 and 30 days after cycle 8, then every 6 months for 3 years
Overall Survival
Time frame: Every 6 months while on treatment and then every 6 months while off of treatment for up to 3 years
Evaluate Safety and Tolerability of Bortezomib and Gemcitabine Therapy
Time frame: During treatment through a maximum of 8 Cycles (1 Cycle = 28 Days) and 30 days post last treatment

Results and safety

Results posted to the registry on 28 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2	5	0
Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2	6	0
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8	7	1
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15	14	2

Primary outcome: Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.

Time frame: At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8. Number. Unit: participants

Measure	Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2 n = 0	Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 n = 0	Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8 n = 1	Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15 n = 2
Value	–	–	1	2

Population analysed: Patients must complete 3 cycles of treatment to be evaluable for this outcome measure. Only 3 patients reached Cycle 3 and the study closed before accrual was met due to lack of efficacy. Below shows response of patients that reached Cycle 3 and is not a reflection of response rate.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of treatment through 30 days post treatment. The study was designed for a maximum of 8 Cycles of treatment (1 Cycle = 28 days) and the range of cycles attemted by any patient was 1 - 8.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.3 mg/m2	4 of 5 (80%)	5 of 5 (100%)	5 of 5
Cohort 1 -Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2	2 of 6 (33.3%)	6 of 6 (100%)	6 of 6
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8	3 of 7 (42.9%)	7 of 7 (100%)	7 of 7
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15	6 of 14 (42.9%)	14 of 14 (100%)	11 of 14

Limitations and caveats (from the sponsor): The study was terminated before the accrual goal was met as it was determined that the study lacked efficacy. Most patients did not reach 3 cycles of treatment in order to be evaluable for response.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leo Gordon, MD principal investigator

Northwestern University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bortezomib and gemcitabine hydrochloride in people with Lymphoma, run by Northwestern University 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?

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: stopped early, as of the sponsor's last update on 28 May 2019. 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 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?

Yes. Results are posted in the registry (first posted 28 May 2019). 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?

Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment. (time frame: At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8). 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 NCT00290706.

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 28 May 2019.