PER-166-08
Completed
未知
A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin´s Lymphoma
PharmaMar,0 sites0 target enrollmentFebruary 9, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C82 Follicular lymphoma-C83 Non-follicular lymphoma-C85 Other and unspecified types of non-Hodgkin lymphoma
- Sponsor
- PharmaMar,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Obtain written informed consent before the start of any specific study procedure.
- •Histologically confirmed aggressive lymphomas
- •The patient requires treatment because NHL has recurred after the response to chemotherapy at standard or high doses \+ germ cell transplantation, or NHL is refractory (that is, it has not been possible to achieve at least RC, RP or EE) at most recent chemotherapy.
- •Autotransplantation and / or germ cell allotransplantation is allowed. In case of hematopoietic germ cell allogeneic transplantation (HSCT), the patient must be without immunosuppressive medication before being able to be included.
- •The disease is measurable: existence of a two\-dimensional lesion larger than 2 cm in its largest diameter or malignant lymphocytosis greater than 5 x 10 ^ / L. Another procedure for the formulation of measurable disease could be allowed in a given case if approved by PharmaMar.
- •Resolution of all non\-hematological toxicity resulting from previous treatments. The presence of alopecia and symptomatic peripheral neuropathy of grade \<2 of NCI CTCs is allowed.
- •Age\> 18 years.
- •Functional status (ECOG) \<2
- •Appropriate renal, hepatic and bone marrow functions (evaluated \<14 days before inclusion in the study)
Exclusion Criteria
- •Pretreatment with Aplidin®
- •Concomitant treatment with any antilinfoproliferative agent, including glucocorticoids at a daily dose greater than 10 mg of prednisone or equivalent, unless they were indicated for symptom control and disease progression had been documented while the patient was on steroids.
- •Acute lymphoblastic leukemia.
- •Lymphoma in CNS.
- •Lymphoma associated with HIV.
- •Previous gene therapy with viral vectors.
- •More than three previous lines of systemic biological agents or systemic chemotherapies. (Bone marrow transplantation and germ cell transplantation as consolidation therapy of a previous response are considered as a chemotherapy line).
- •Washing periods from the end of the previous treatment under: 6 weeks for chemotherapy with nitrosoureas or high\-dose chemotherapy, 3 weeks for other chemotherapies or biological agents, 4 weeks for radiotherapy or radionuclide treatment (6 weeks in the case of previous extensive external radiotherapy (distribution over more than 25% of bone marrow)), 4 weeks for previous major surgery, 30 days for any product under investigation, 4 weeks for immunosuppressive treatment after germ cell allogeneic transplantation hematopoietic
- •Pregnant or breastfeeding women.
- •Men and women of childbearing age who do not use effective contraceptive methods
Outcomes
Primary Outcomes
Not specified
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