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Neoplasms by Histologic Type

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Diffuse Large B-Cell Lymphoma

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Etoposide

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Ofatumumab

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Adjuvants, Immunologic

Folinic Acid

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Ofatumumab Etoposide Ifosfamide Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Colony Stimulating Factor

1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles

60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles

1500mg/m2 or 1000mg/m2 (patients \>/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles

Ifosfamid

300mg/m2 or 200mg/m2 (patients \>/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients \>/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles

2g/m2 or 0,5-1g/m2 (patients \>/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles

12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles

Leukovorin

5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l

Granulocyte-Colony Stimulating Factor

Jan Walewski, Prof.

Krzysztof Warzocha, Prof.

Andrzej Hellmann, Prof.

Andrzej Pluta, Prof.

Andrzej Lange, Prof.

Wanda Knopinska-Posluszny, MD PhD

Sebastian Giebel, Prof.

Jan M Zaucha, Prof.

It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous Stem Cell Transplant (ASCT).

The purpose of this study is to assess the Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR) in adult Diffuse Large B Cell Lymphoma (DLBCL) patients progressing or relapsed after prior R-CHOP treatment not suitable for ASCT treated with O-IVAC salvage chemotherapy regimen. The secondary objective is the evaluation of progression-free survival (PFS), event-free survival (EFS), overall survival (OS), safety and tolerability.

Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

A Phase II Trial on Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients Progressing or Relapsed After Prior R-CHOP Treatment Not Suitable for Autologous Stem Cell Transplant

Staying free of event such as disease progression, relapse, death, starting new anticancer therapy, patient's refusal to continue study treatment, Serious Adverse Event that causes discontinuation of study treatment

Time since entering the study till death of any reason

Reporting Adverse Events and Serious Adverse Events

Polish Lymphoma Research Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients	NCT01481272	Diffuse Large B...	Ofatumumab Etoposide Ifosfamid Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Col...	18 Years -	Polish Lymphoma Research Group
Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients	NCT01481272	Diffuse Large B...	Ofatumumab Etoposide Ifosfamid Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Col...	18 Years -	Polish Lymphoma Research Group

Spots Global Cancer Trial Database for ifosfamid

Every month we try and update this database with for ifosfamid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ifosfamid

Every month we try and update this database with for ifosfamid cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ifosfamid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.