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Clinical Trials/EUCTR2004-001117-34-ES
EUCTR2004-001117-34-ES
Active, not recruiting
Phase 1

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.

Pharma Mar S.A.0 sites0 target enrollmentSeptember 16, 2004
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Pharma Mar S.A.
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 16, 2004
End Date
June 16, 2010
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Written informed consent obtained before starting any study\-specific procedure.
  • •2\. Histologically confirmed aggressive lymphomas, including the following:
  • •2\.1 B\-Cell neoplasms.
  • •2\.1\.1 Precursor B\-cell neoplasm
  • •2\.1\.1\.1\.1 Precursor B\-lymphoblastic lymphoma
  • •2\.1\.2 Mature (peripheral) B\-cell neoplasms
  • •2\.1\.2\.1\. 1 Follicular lymphoma (histologic conversion)
  • •2\.1\.2\.1\. 2 Mantle\-cell lymphoma (diffuse pattern or blastic variant)
  • •2\.1\.2\.1\. 3 Diffuse large B\-cell lymphoma
  • •2\.1\.2\.1\. 4 Mediastinal large B\-cell lymphoma

Exclusion Criteria

  • •1\. Prior therapy with Aplidin®.
  • •2\. Concomitant therapy with any anti\-lymphoproliferative agent, including glucocorticoids at a daily dose greater than 10 mg prednisone or equivalent, except when they were indicated for symptom control and disease progression was documented while on esteroids.
  • •3\. Acute lymphoblastic leukemia.
  • •4\. CNS lymphoma.
  • •5\. HIV\-associated lymphoma.
  • •6\. Prior gene therapy with viral vectors.
  • •7\. More than three previous lines of systemic biological agents or chemotherapies. (Bone marrow or stem cell transplantation as consolidation therapy of a previous response is understood as one line of chemotherapy).
  • •8\. Wash\-out periods since the end of the precedent therapy less than:
  • •o6 weeks for nitroso\-urea or high dose chemotherapy
  • •o4 weeks for other chemotherapies or biological agents

Outcomes

Primary Outcomes

Not specified

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