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A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

Phase 2
18 Years
Not Enrolling
Lymphoma, Large-Cell, Diffuse

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Trial Information

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

Rituximab combined with anthracycline based chemotherapy is the most common first-line
treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring
second-line therapy will most often receive rituximab in combination with salvage
chemotherapy as an induction therapy prior to autologous stem cell transplant. With
rituximab being in first-line therapy, the response rates for subjects receiving rituximab
plus salvage chemotherapy has significantly decreased. Treatment with ofatumumab may be
able to overcome the resistance to rituximab in the second-line setting and offer improved
response rates. The objective of this study is to evaluate the overall response rate of
ofatumumab in combination with ICE or DHAP chemotherapy prior to autologous stem cell
transplant. Additional objectives are to evaluate the complete response rate, ability to
mobilize cluster of differentiation (CD)34+ cells, progression-free survival (PFS) and
overall survival.

Inclusion Criteria:

- Subjects with CD20 positive aggressive non-Hodgkin's lymphoma (NHL) including DLBCL,
transformed follicular lymphoma (FL) & grade 3b FL.

Refractory to, or relapsed following, first-line treatment with rituximab combined with
anthracycline- or anthracenedione-based chemotherapy as defined by the protocol.

- Computed tomography (CT) with involvement of 2 or more clearly demarcated lesions
with a long axis > 1.5 centimeters (cm) and short axis ≥ 1.0 cm or 1 clearly
demarcated lesion with a long axis >2.0 cm and short axis ≥1.0 cm.

- Baseline [18F] fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans must
demonstrate positive lesions compatible with CT defined anatomical tumor sites.

- Age 18 yrs or older.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

- Eligible for high dose chemotherapy and autologous stem cell transplant (ASCT).

- Resolution of toxicities from first-line therapy to a grade that in the opinion of
the investigator does not contraindicate study participation.

- Signed written informed consent.

Exclusion Criteria:

- Previous cancer therapy for lymphoma, with the exception of required rituximab/
anthracycline- or anthracenedione-based chemotherapy, monotherapy rituximab prior to
first-line therapy and / or as a maintenance therapy, or limited field radiotherapy
(as defined by the protocol).

- Any anti-cancer therapy, except limited field radiotherapy, within 2 weeks prior to
start of study therapy.

- Chronic Glucocorticoid use (limited acute use is allowed and defined by the

- History of significant cerebrovascular disease.

- Abnormal/ inadequate white blood cell (WBC) count, liver, and kidney function.

- Clinically significant cardiac disease, active or chronic infections, serious
significant diseases, other cancer within last 5 years.

- Known or suspected hypersensitivity to study treatments.

- Prior treatment with anti-CD20 monoclonal antibodies, at any time, or treated with
other monoclonal antibodies within 3 months prior to start of study therapy, with the
exception of rituximab in both instances.

- Inability to comply with the protocol activities.

- Pregnant or lactating women or female patients of child-bearing potential (or male
patients with such partners) not willing to use adequate contraception during and up
to 1 year following dosing completion.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Overall Response (OR), as Assessed by the Investigator

Outcome Description:

Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.

Outcome Time Frame:

From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

September 2011

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • Salvage chemotherapy
  • relapsed
  • grade 3B follicular lymphoma
  • efficacy
  • safety
  • DHAP
  • ofatumumab
  • refractory
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Oncology
  • ICE
  • Transformed follicular lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse