Phase 2
N=67
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma
Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00884286 ↗Enrolled (actual)
67
Serious AEs
37.5%
Results posted
Mar 2018
Primary outcome: Primary: Objective Response Rate — 2; 4; 6; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aplidin® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PharmaMar
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
2; 4; 6; 17; 5; 0 | — |
| SECONDARY Time to Response Onset |
7.5 | — |
| SECONDARY Duration of Response |
2.2 | — |
| SECONDARY Time to Progression |
1.6; 1.3 | — |
| SECONDARY Time to Subsequent Chemotherapy |
3.8; 1.9 | — |
| SECONDARY Progression-free Survival |
1.6; 1.3 | — |
| SECONDARY Overall Survival |
10.2; 4.5 | — |
Summary
This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Histologically confirmed aggressive lymphomas,
- Patient requires treatment because NHL relapses
- Measurable disease
- Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade 18 years.
- Performance status (ECOG) < 2
- Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study)
- Left ventricular ejection fraction within normal limits.
Exclusion Criteria
- Prior therapy with Aplidin®.
- Concomitant therapy with any anti-lymphoproliferative agent
- Acute lymphoblastic leukemia.
- CNS lymphoma.
- HIV-associated lymphoma.
- Prior gene therapy with viral vectors.
- More than three previous lines of systemic biological agents or chemotherapies. Wash-out periods since the end of the precedent therapy less than:
- 6 weeks for nitroso-urea or high dose chemotherapy
- 3 weeks for other chemotherapies or biological agents
- 4 weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
- 4 weeks for major prior surgery
- 30 days for any investigational product
- 4 weeks for immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation.
- Pregnant or lactating women.
- Men and women of reproductive potential who are not using effective contraceptive methods
- History of another neoplastic disease. Exceptions: Non-melanoma skin cancer,cCarcinoma in situ of any site,any other cancer curatively treated and no evidence of disease for at least 10 years.
- Known cerebral or leptomeningeal involvement.
- Other relevant diseases or adverse clinical conditions
- Treatment with any investigational product in the 30 days period before inclusion in the study.
- Known hypersensitivity to Aplidin®, mannitol, cremophor EL, or ethanol
- Limitation of the patient's ability to comply with the treatment or follow-up protocol.
Data sourced from ClinicalTrials.gov (NCT00884286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.