Mantle Cell LymphomaPhase 2NCT00090090
Elsamitrucin (SPI 28090) for Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 2 study testing Elsamitrucin in people with Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Spectrum Pharmaceuticals, Inc at 7 sites in United States.
Trial summary
To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- What is being tested?
- Elsamitrucin
- How many people
- 114 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2004to Oct 2006
- 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
- Relapsed or Refractory mantle cell lymphoma and/or CLL/SLL except Burkitt's, Burkitt's like or HIV-associated lymphoma
- at least one prior cytotoxic chemotherapy regimens
- measurable disease
- adequate bone marrow, liver and kidney function
- ECOG PS 0-2
Who cannot join
- prior treatment with elsamitrucin
- prior chemo, antibody or radiotherapy for NHL within 28 days prior to start to treatment
- HIV positive or known AIDS syndrome
- uncontrolled medical disease or psychiatric condition/s
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Alta Bates Cancer Center
Berkeley, California, 94704
Providence Saint Joseph Medical Center
Burbank, California, 91505
USC Norris Cancer Center
Los Angeles, California, 90033
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
North Shores University Hospital
Manhasset, New York, 11021
North Valley Hematology Oncology Medical Group
Mission Hills, California, 91343
Cancer and Blood Institute Medical Group
Rancho Mirage, California, 92270
About this study
Official title: A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s).
- Being tested
- Elsamitrucin
- Medical subject headings
- Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElsamitrucinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2004 (estimated)
- Study startApr 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090090
- Sponsor's protocol ID
- ELSA 2004-001
- Status last verified
- Jan 2008
- First submitted
- 24 Aug 2004
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen SL, Schacter LP, Lichtman SM, Bukowski R, Fusco D, Hensley M, O'Dwyer P, Mittelman A, Rosenbloom B, Huybensz S. Phase II study of elsamitrucin (BMY-28090) for the treatment of patients with refractory/relapsed non-Hodgkin's lymphoma. Invest New Drugs. 1996;14(2):213-7. doi: 10.1007/BF00210793.
PubMed 8913843
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00090090
- Acronym / sponsor ID
- ELSA 2004-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 25 Aug 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.
To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Relapsed or Refractory mantle cell lymphoma and/or CLL/SLL except Burkitt's, Burkitt's like or HIV-associated lymphoma
- at least one prior cytotoxic chemotherapy regimens
- measurable disease
- adequate bone marrow, liver and kidney function
- ECOG PS 0-2
Key exclusion criteria (4 listed)
- prior treatment with elsamitrucin
- prior chemo, antibody or radiotherapy for NHL within 28 days prior to start to treatment
- HIV positive or known AIDS syndrome
- uncontrolled medical disease or psychiatric condition/s
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 |
|---|---|---|
| Elsamitrucin | Drug | – |
Primary outcome
Not reported in the source record.
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 Jan 2008.
- Background: PubMed 8913843Allen SL, Schacter LP, Lichtman SM, Bukowski R, Fusco D, Hensley M, O'Dwyer P, Mittelman A, Rosenbloom B, Huybensz S. Phase II study of elsamitrucin (BMY-28090) for the treatment of patients with refractory/relapsed non-Hodgkin's lymphoma. Invest New Drugs. 1996;14(2):213-7. doi: 10.1007/BF00210793.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elsamitrucin in people with Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Spectrum Pharmaceuticals, Inc 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 4 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 Jan 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00090090, which also lists 1 linked publication.
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 Jan 2008.