A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
1 other identifier
interventional
25
1 country
1
Brief Summary
For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2001
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2001
CompletedFirst Submitted
Initial submission to the registry
May 31, 2002
CompletedFirst Posted
Study publicly available on registry
June 3, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2004
CompletedOctober 30, 2018
October 1, 2018
2.9 years
May 31, 2002
October 29, 2018
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anas Younes, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2002
First Posted
June 3, 2002
Study Start
May 18, 2001
Primary Completion
April 27, 2004
Study Completion
April 27, 2004
Last Updated
October 30, 2018
Record last verified: 2018-10