Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase II, Single-Arm Trial of Naked Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients with Waldenström's Macroglobulinemia

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Resumen

2017-03-15 03:55:37
2004-001563-21
IM-T-hLL2-18
A Phase II, Single-Arm Trial of Naked Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients with Waldenström's Macroglobulinemia
hLL2-18
IM-T-hLL2-18

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Immunomedics, Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
epratuzumab
IMMU-103 Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
IMMU-103 hLL2

Concentración del fármaco:
mg/ml milligram range

9 to 11

Contenido del fármaco

Information no disponible en EudraCT
Si

No
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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

Waldenström's Macroglobulinemia (WM) is an uncommon B-cell lymphoproliferative disorder that predominantly involves older patients with a slight male preponderance. WM resembles myeloma and chronic lymphocytic leukemia, but has been described as a low-gr

The primary objective is to evaluate the efficacy of epratuzumab in WM as determined by the response rate for patients with partial or complete responses.

To evaluate the duration of response (DR) and time to progression (TTP). To examine the safety, tolerability and immunogenicity of epratuzumab as determined by adverse experiences/toxicity, changes in vital signs and criticial laboratory data and human anti-human antibodies (HAHA). To obtain pharmacokinetics determined from serum epratuzumab levels and pharmacodynamics determined from peripheral blood B-cell counts.

Information no disponible en EudraCT


1. Male or females, 18 years old or greater.2. Documented diagnosis of WM satisfying criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.3. Measurable disease, defined as serum monoclonal IgM protein greater than or equal to 1000 mg/dL by electrophoresis.4. Lymphoplasmacytic infiltration of the bone marrow > 10% involvement.5. Failed at least one, but no more than 3, regimen(s) of prior therapy.6. Karnofsky Performance Status (KPS) greater than or equal to 60.7. Minimal life expectancy of 6 months.8. Must be willing and able to give informed consent.

1. Pregnant women.2. Lactating women, unless they agree not to breastfeed for a period of 3 months after completing treatment.3. Women of childbearing potential and fertile men who are unwilling to practice birth control during and for a period of 12 weeks after completing treatment.4. Major surgery, radiation, chemotherapy, stem cell transplant, or any other therapy within 4 weeks prior to enrollment and recovered from all treatment-related toxicity.5. Prior therapies must not include more than one prior therapy with rituximab, and patients who were refractory to rituximab are excluded, where refractory is defined as failure to achieve an objective response to rituximab or having progression of disease within 6 months after rituximab.6. Prior therapy with other murine, chimeric, human or humanized monoclonal antibodies, unless HAHA is negative.7. Prior treatment with any other investigational agents, unless follow-up is completed and patient is off study.8. < 2 weeks beyond corticosteroids.9. Hemoglobin < 7.0 g/dL, absolute neutrophil count, < 1000 mm³, platelets < 50,000/mm³, without ongoing transfusional support.10. Serum creatinine > 1.5 X Institutional Upper Limit of Normal (IULN).11. Serum bilirubin > 1.5 X ILUN, Alkaline phosphatase > 1.5 IULN, ALT (SGPT > 1.5 X IULN and/or AST (SGOT) > 1.5 X IULN.12. Other primary malignancy (other than squamous or basal cell skin cancer, or cervical cancer in-situ) within 5 years.13. Known HIV positive or active hepatitis B or C or presence of hepatitis B or C surface antigens.14. Significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

Toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria, version 3.0. Treatment responses will be categorized according to response criteria from 2nd International Workshop on WM. Treatment efficacy will be assessed by overall response rates (PR, CR) as well as duration of response and time-to-progression; safety, from adverse events, toxicity, and changes in vital signs or laboratory values; pharmacokinetics, from IMMU-103 levels; pharmacodynamics, from B-cell levels; and immunogenicity, from HAHA titers.

Fase II
  DISEÑO DEL ENSAYO:

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:

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

5
  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:

Para estudios internacionales:


53

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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