LymphomaPhase 2NCT00086034
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma
A Phase 2 study testing Motexafin gadolinium in people with Lymphoma and Non-Hodgkin's Lymphoma, run by Pharmacyclics LLC. at 7 sites in United States.
Trial summary
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- Motexafin gadolinium
- How many people
- 35 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- 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
- ≥ 18 years old
- Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
- Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
- ECOG performance status score either 0 or 1
- Willing and able to provide written informed consent
Who cannot join
- Laboratory values of:
- Platelet count < 50,000/µL
- AST or ALT > 2 x the upper limit of normal (ULN)
- Total bilirubin > 2 x ULN
- Creatinine > 2.0 mg/dL
- and
Show all 9Show fewer
- Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
- Uncontrolled hypertension
- Known history of porphyria, G6PD deficiency, HIV
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Baltimore, Maryland, 21231
Study site
Chicago, Illinois, 60611
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33136
Study site
Rochester, Minnesota, 55905
Study site
San Diego, California, 92121
Study site
Stanford, California, 94305
About this study
Official title: Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.
- Conditions
- Lymphoma, Non-Hodgkin's Lymphoma
- Being tested
- Motexafin gadolinium
- Keywords
- Lymphoma, Non-Hodgkin's Lymphoma, Indolent lymphoma, Relapsed lymphoma, Refractory lymphoma, Motexafin gadolinium
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin gadoliniumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Secondary outcomes (3)
Progression-free survival
Duration of clinical response
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Brad Kahl, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086034
- Sponsor's protocol ID
- PCYC-0221
- Status last verified
- May 2007
- First submitted
- 21 Jun 2004
- Last updated
- 15 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00086034
- Acronym / sponsor ID
- PCYC-0221
- Conditions
- Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Lymphoma, Non-Hodgkin's Lymphoma, Indolent lymphoma, Relapsed lymphoma, Refractory lymphoma, Motexafin gadolinium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- First posted
- 23 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old
- Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
- Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
- ECOG performance status score either 0 or 1
- Willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Platelet count < 50,000/µL
- AST or ALT > 2 x the upper limit of normal (ULN)
- Total bilirubin > 2 x ULN
- Creatinine > 2.0 mg/dL
- and
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 |
|---|---|---|
| Motexafin gadolinium | Drug | – |
Primary outcome
Clinical response rate
3 secondary outcomes
Progression-free survival
Duration of clinical response
Safety and tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
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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.
Brad Kahl, MD principal investigator
University of Wisconsin, Madison
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motexafin gadolinium in people with Lymphoma and Non-Hodgkin's Lymphoma, run by Pharmacyclics LLC. at 7 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 5 inclusion and 9 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 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2007.