Non-Hodgkin's LymphomaPhase 2NCT00038545
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase 2 study testing Filgrastim SD/01, Paclitaxel and Topotecan in people with Non-Hodgkin's Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Filgrastim SD/01, Paclitaxel and Topotecan
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2001to 27 Apr 2004
- 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
- Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma \& transformed lymphoma.)
- No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks.
- Not be eligible for treatment of a higher priority.
- Performance status <2 Zubrod, > 60 Karnofsky.
- Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L.
- Bilirubin <1.5mg/dL, SGOT, SGPT < 2 x normal values.
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- Serum creatinine < 1.8 mg/dL.
- Age > 18 yrs.
- Signed informed consent.
- Life expectancy of > 12 weeks.
- No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11.
- No prior stem cell or bone marrow transplantation.
- No prior second malignancies except for basal cell carcinoma of the skin.
Who cannot join
- Active or prior history of CNS lymphoma.
- Serious intercurrent medical illnesses requiring hospitalization.
- History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids).
- Prior exposure to Filgrastim-SD/01.
- Women who are pregnant or lactating.
- Participation in another clinical trial.
- Positive HIV antibody.
- History of prior sensitivity to E. coli derived products (such as filgrastim/neupogen).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Filgrastim SD/01, Paclitaxel, Topotecan
- Keywords
- LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim SD/01Drug
PaclitaxelDrug
TopotecanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2002 (estimated)
- Study start18 May 2001
- Primary completion27 Apr 2004
- Study completion27 Apr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anas Younes, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038545
- Sponsor's protocol ID
- DM01-008
- Status last verified
- Oct 2018
- First submitted
- 31 May 2002
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00038545
- Acronym / sponsor ID
- DM01-008
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 May 2001
- Primary completion
- 27 Apr 2004 (actual)
- Study completion
- 27 Apr 2004 (actual)
- First posted
- 3 Jun 2002 (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.
For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma
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 (13 listed)
- Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma \& transformed lymphoma.)
- No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks.
- Not be eligible for treatment of a higher priority.
- Performance status <2 Zubrod, > 60 Karnofsky.
- Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L.
Key exclusion criteria (8 listed)
- Active or prior history of CNS lymphoma.
- Serious intercurrent medical illnesses requiring hospitalization.
- History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids).
- Prior exposure to Filgrastim-SD/01.
- Women who are pregnant or lactating.
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 |
|---|---|---|
| Filgrastim SD/01 | Drug | – |
| Paclitaxel | Drug | – |
| Topotecan | 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 30 Oct 2018.
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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.
Anas Younes, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim SD/01, Paclitaxel and Topotecan in people with Non-Hodgkin's Lymphoma, run by M.D. Anderson Cancer Center 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 13 inclusion and 8 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 30 Oct 2018. 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 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?
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 30 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.