Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Lymphoma

Leukemia

Aggression

Leukemia-Lymphoma, Adult T-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Lymphosarcoma

Aplidin® given as a 1-hour weekly IV infusion

Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.

Aplidin®

Vincent Ribrag, MD

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.

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.

Primary

• To assess the anti-tumour activity of Aplidin® given as a 1-hour weekly IV infusion, in patients with aggressive non-Hodgkin's Lymphoma, relapsing or refractory to a prior therapy.

Secondary

* To further investigate the safety profile of Aplidin® given as 1-hour weekly IV infusion in this patient population.
* To obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma

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

The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkin's Lymphoma.

The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkin's Lymphoma (NHL).

Time to response onset was defined as the time from the first day of plitidepsin treatment to the first documentation of response.

Duration of response was defined as the time from the first documented objective response (CR, CRu or PR) to disease progression or death. Patients who had not progressed or died were to have their duration censored at the date of their last disease assessment.

Time to progression (TTP) was to be calculated from the first day of plitidepsin treatment to the date of disease progression.

Time to subsequent therapy was to be calculated from the first infusion of the study drug to the start date of the subsequent therapy. Patients without subsequent therapy were to be censored at their last reported date.

Progression-free survival (PFS) was to be calculated from the date of registration to the date of first objective disease progression or death from any cause. Patients who were lost to follow-up without documentation of progression were to be censored at the last date they were assessed and found progression-free.

A patient receiving a new treatment in the absence of documented progression was to be considered as progressing at the time of re-treatment.

Overall survival (OS) was to be calculated from the date of registration to the date of death from any cause. Patients with no documented death were to be censored at the last date they were known to be alive.

PharmaMar

Only 64 out of 67 included patients were treated, therefore, 64 patients were considered as participant at risk.

Aplidin® given as a 1-hour weekly IV infusion

Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.

Aplidin® (Cohort Non-cutaneous PTCL)

Aplidin® (Cohort Other Lymphomas)

Aplidin® (Cohort Non-cutaneous)

Aplidin® (Cohort Other Lymphoma)

Total

17 years

Between 18 and 49 years

Between 50 and 69 years

>= 70 years

A 17 year-old patient was included and it was considered by the Sponsor as a non-clinically relevant protocol deviation.

Age, Customized

Sex: Female, Male

Italy

France

Switzerland

Peru

Spain

Region of Enrollment

Clinical Development Department of PharmaMar´s Oncology,Business Unit.,

Non-cutaneous PTCL

Other lymphomas

Arm One

The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous Peripheral T-cell Lymphoma (PTCL), and for the subset of treated patients with other lymphomas.

Objective Response Rate

Arm One (Non-cutaneous PTCL Cohort)

The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.

Six responders belong to the Non-cutaneous PTCL cohort

Time to Response Onset

The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.

The six responders belong to the Non-cutaneous PTCL cohort.

Duration of Response

The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma	NCT00884286	Leukemia Lymphoma	Aplidin®	18 Years -	PharmaMar
Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma	NCT00884286	Leukemia Lymphoma	Aplidin®	18 Years -	PharmaMar

Spots Global Cancer Trial Database for aggressive non hodgkin lymphoma