Hemotrial Un proyecto de SEHH

Ensayo clínico

Pixantrone (BBR 2778) versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

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Resumen

2017-03-15 03:55:22
2004-000480-10
PIX301
Pixantrone (BBR 2778) versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma: A Randomized, Controlled, Phase III Comparative Trial
N/A
PIX301

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
CELL THERAPEUTICS INC. (EUROPE)-SEDE SECONDARIA Italy

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Lastet Inyectable
Almirall Prodesfarma S.A. Pixantrone
BBR 2778 Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

BBR 2778

Concentración del fármaco:

mg milligram(s) equal

50

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Comparator Novantrone 20 mg, solucion inyectable
Wyeth Farma, S.A. Lastet Inyectable
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

20

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Comparator
Novantrone 20mg, solucion inyectable
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

2

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

Non-Hodgkin's Lymphoma


The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents in terms of complete response (CR) and unconfirmed complete response (CRu) rate according to the report of the international workshop to standardize response criteria for Non Hodgkin's Lymphoma

Secondary objectives are to compare efficacy as demonstrated by overall survival, CR and CRu rate in histologically confirmed patients, objective overall response lasting at least 4 months, and time to progression. Additional pre specified analyses will be overall response rate, time to initial response, time to complete response, duration of response, dose intensity, cardiac function, and safety

Information no disponible en EudraCT


All of the following characteristics are required for study eligibility:1. Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification. The histological specimen used to determine eligibility must be the most recently obtained specimen. Lymph node biopsy slides or tissue blocks suitable for review must be available. - follicular lymphoma – grade III- transformed indolent lymphoma- diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, primary effusion lymphoma (includes previously called immunoblastic lymphoma)- peripheral T-cell lymphoma, not otherwise characterized(encompasses diffused mixed cell lymphoma)- anaplastic large cell lymphoma, T/null cell, primary systemic typeNote: patients with any Ann Arbor stage, International Prognostic Index (IPI) score or bone marrow status are eligible.2. Patients must have received rituximab in prior regimens in those countries where it is available and when neoplastic cells express CD20.3. At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion. Patients with the following sites of disease are NOT eligible:- Patients with only skin lesions or only palpable lymph nodes. - Patients with spleen or bone marrow as only site of disease. 4. Relapse after 2 or more prior regimens of chemotherapy, including:- first line treatment with a standard anthracycline-containing regimen such as CHOP or equivalent- at least one additional combination chemotherapy regimen. High dose chemotherapy or chemoradiotherapy with autologous stem cell support counts as one prior regimen.5. Patients must be sensitive to anthracycline/anthracenedione. Sensitive is defined as:- Previously responded to anthracycline/anthracenedione, and - Relapsed after a response duration ?6 months.6. Age ?18 years. 7. ECOG performance status of ?2.8. Life expectancy ?3 months according to investigator opinion.9. Hb ? 8g/dL, neutrophils ?1.5 x 10exp9/L and platelets ?100 x10exp9/L. If there is bone marrow involvement then neutrophils >0.5 x 10exp9/L and platelets >50 x 10exp9/L is acceptable.10. Serum bilirubin ?1.5 x the institution’s upper limit normal (ULN) and creatinine ? 1.5 ULN and alkaline phosphatase ? 2.0 x the institution’s ULN and AST or ALT? 2.0 x the institution’s ULN. If hepatic involvement by lymphoma is present, AST or ALT may be ? 5.0 x the institution’s ULN.11. Patients previously treated with one of the comparative agents must be sensitive to that agent, if it will be used in this trial. Sensitive is defined as: - Previously responded to that agent, and- Relapsed after a response duration ? 6 months.12. Patients must have recovered from all acute toxicities from prior therapy (except alopecia and grade 1 peripheral neuropathy).13. LVEF ?50% determined by MUGA scan.14. Ability to comply with the visit schedule and assessments required by the protocol. 15. Signed approved informed consent, with understanding of study procedures.

None of the following characteristics may be present:1. Prior treatment with a cumulative dose of doxorubicin or equivalent (see section 17.2) exceeding 450 mg/m² according to the following calculation index: X/450 + Y/160 < 1where X is the doxorubicin dose in mg/m² and Y the mitoxantrone dose in mg/m².2. Prior allogenic stem cell transplant.3. Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma.4. Active CNS lymphoma.5. HIV-related lymphoma.6. Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 4 weeks before randomization.7. Major thoracic and/or abdominal surgery within the 4 weeks before randomization from which the patient has not fully recovered. Patients who have had minor surgery may be enrolled after a ?1 week recovery period.8. Clinically significant cardiovascular abnormalities (equal to NYHA grade II - IV), myocardial infarction within the prior 6 months, severe arrhythmia or uncontrolled hypertension.9. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.10. History of or clinical symptoms suggesting HIV, HBV or HCV infection. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B virus will not be excluded.11. History of another malignancy except cured basal cell carcinoma of skin or carcinoma in–situ of uterine cervix.12. Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise unsuitable.13. Other investigational drug study within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.14. Pregnant women or nursing mothers. 15. Potentially fertile men and women not willing to use adequate contraception during the study and for 6 months after the last day of study drug administration.16. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Complete response (CR) and unconfirmed Complete response (CRu) rate: The total proportion of patients with CR or CRu.CR and CRu will be defined according to the report of the international workshop to standardize response criteria for NHL.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

3
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


20

Para estudios internacionales:


250
320

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha