Recruitment

Recruitment Status
Completed
Estimated Enrollment
139

Inclusion Criterias

Life expectancy ≥ 6 months.
Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
...
Life expectancy ≥ 6 months.
Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
Age ≥ 18 and ≤ 80 years at time of enrolment.
Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.

Exclusion Criterias

For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
Inadequate renal, hematologic, or hepatic function.
History of Human Immunodeficiency Virus (HIV) positive status.
...
For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
Inadequate renal, hematologic, or hepatic function.
History of Human Immunodeficiency Virus (HIV) positive status.
For participants with FL: contraindication to standard chemotherapy.
Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.
Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.
Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.
History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.
Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
Other serious underlying medical conditions.
Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.
Transformed lymphoma.

Summary

Conditions
Lymphoma, Non Hodgkin
Type
Interventional
Phase
Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Inclusion Criterias

Life expectancy ≥ 6 months.
Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
...
Life expectancy ≥ 6 months.
Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
Age ≥ 18 and ≤ 80 years at time of enrolment.
Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.

Exclusion Criterias

For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
Inadequate renal, hematologic, or hepatic function.
History of Human Immunodeficiency Virus (HIV) positive status.
...
For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
Inadequate renal, hematologic, or hepatic function.
History of Human Immunodeficiency Virus (HIV) positive status.
For participants with FL: contraindication to standard chemotherapy.
Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.
Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.
Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.
History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.
Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
Other serious underlying medical conditions.
Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.
Transformed lymphoma.

Locations

Fuenlabrada, Madrid, 28943
Elda, Alicante, 03600
Santiago de Compostela, LA Coruña, 15706
Guadalajara, 19002
Logroño, LA Rioja, 26006
...
Fuenlabrada, Madrid, 28943
Elda, Alicante, 03600
Santiago de Compostela, LA Coruña, 15706
Guadalajara, 19002
Logroño, LA Rioja, 26006
Madrid, 28031
Bilbao, Vizcaya, 48013
Madrid, 28040
Burgos, 09006
La Coruna, LA Coruña, 15006
Palma de Mallorca, Islas Baleares, 07198
Malaga, 29010
Pontevedra, 36071
Madrid, 28050
León, Leon, 24008
Madrid, 28805
Leganes, Madrid, 28911
Terrassa, Barcelona, 08221
Sevilla, 41009
Pamplona, Navarra, 31008
Madrid, 28222
Mostoles, Madrid, 28935
Castellon, 12004
Vigo, Pontevedra, 36204
Vitoria, Alava, 01009
Granada, 18014
Cordoba, 14004
Lerida, 25198
Murcia, 30008
Granollers, Barcelona, 08400
Valladolid, 47010
Segovia, 40002
Santa Cruz de Tenerife, Tenerife, 38010
Galdakao, Vizcaya, 48960
Madrid, 28040
Pamplona, Navarra, 31008
Almeria, 04009
Sevilla, 41014
Murcia, 30120

Tracking Information

NCT #
NCT01987505
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche