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Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma


Phase 2
19 Years
N/A
Open (Enrolling)
Both
Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Small Lymphocytic Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma

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Trial Information

Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma


PRIMARY OBJECTIVES:

I. To evaluate the safety of Pegfilgrastim in combination with rituximab in patients with
untreated or relapsed/refractory follicular, SLL or MZL.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy (including overall response rate and durability of objective
responses) of Pegfilgrastim in combination with rituximab in patients with untreated or
relapsed/refractory follicular, SLL or MZL.

II. To evaluate functional and phenotypic characteristics of host neutrophils undergoing
treatment with Pegfilgrastim and rituximab.

III. To evaluate changes in cluster of differentiation (CD)20 antigen expression and density
of expression in patients receiving Pegfilgrastim and rituximab.

IV. To evaluate changes in serum levels of tumor necrosis factor (TNF), interferon alpha
(INFalpha) and free radical levels in patients undergoing treatment with Pegfilgrastim and
rituximab.

OUTLINE:

Patients receive pegfilgrastim subcutaneously (SC) followed by rituximab intravenously (IV)
3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 1 year,
every 6 months for 2 years, and then yearly for 1 year.


Inclusion Criteria:



- Untreated or relapsed/refractory follicular, SLL or MZL (i.e. no limit to number of
prior treatments as long as patients meet other study criteria)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Measurable tumor size (at least one node measuring 4 cm^2 in bidimensional
measurement)

- Expected survival of > 6 months

- Prior rituximab or other monoclonal immunotherapy permitted and eligible for
rituximab monotherapy

- Full recovery from any significant toxicity associated with prior surgery, radiation
therapy, chemotherapy, or immunotherapy

- Absolute neutrophil count > 1.0 x 10^9/L

- Platelets > 50 x 10^9/L

- Patients may receive erythropoietin growth factors to maintain adequate hemoglobin
levels (>= 8.0 mg/dl)

- Creatinine < 1.5 x upper normal levels (UNL)

- Total bilirubin < 1.5 mg/dL (> 25.65 umol/L)

- Aspartate aminotransferase < 5 x UNL

- Alkaline phosphatase < 5 x UNL

- Informed consent approved in institutional review board (lRB)

- CD20+ B-cell lymphoma

Exclusion Criteria:

- Prior history of human immunodeficiency virus (HIV)-positivity (routine HIV testing
is required pretreatment)

- Serious non-malignant disease (e.g. active uncontrolled bacterial, viral, or fungal
infections) or other conditions which, in the opinion of the principal investigator
would compromise other protocol objectives

- Presence of central nervous system (CNS) lymphoma

- Chemotherapy within 4 weeks of the first scheduled study treatment

- Another primary malignancy (other than squamous or basal cell carcinoma of the skin
or in-situ carcinoma of the cervix) for which the patient has not been disease-free
for at least five years

- Major surgery, other than diagnostic surgery, within four weeks

- Patients with non-Hodgkin lymphoma (NHL) other than relapsed/refractory follicular,
MZL or SLL

- Patients must not have a history of cardiac disease, defined as New York Heart
Association Class II or greater or clinical evidence of congestive heart failure

- Concurrent use of other investigational agents

- Pregnant or breast feeding

- Subjects of reproductive potential who are not using adequate contraceptive
precautions, in the judgment of the investigator

- Known hypersensitivity to any recombinant E coli-derived product, murine proteins, or
any components of the study medications

- Concerns for the subject's compliance with the protocol

- Any premalignant myeloid condition or any malignancy with myeloid characteristics
(e.g. myelodysplastic syndromes, acute or chronic myelogenous leukemia)

- Patient is currently enrolled in, or has not yet completed at least 30 days since
ending another investigational device or drug trial

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate (ORR)

Outcome Description:

Two-sided 95% exact confidence intervals around the estimates will be calculated. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured. Radiologic evaluation of the extent of disease following therapy will be used to assess response according to the standard World Health Organization (WHO) response criteria.

Outcome Time Frame:

Up to 43 weeks

Safety Issue:

No

Principal Investigator

Francisco Hernandez-ILizaliturri

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 83106

NCT ID:

NCT01682044

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Contiguous Stage II Grade 1 Follicular Lymphoma
  • Contiguous Stage II Grade 2 Follicular Lymphoma
  • Contiguous Stage II Grade 3 Follicular Lymphoma
  • Contiguous Stage II Marginal Zone Lymphoma
  • Contiguous Stage II Small Lymphocytic Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncontiguous Stage II Grade 1 Follicular Lymphoma
  • Noncontiguous Stage II Grade 2 Follicular Lymphoma
  • Noncontiguous Stage II Grade 3 Follicular Lymphoma
  • Noncontiguous Stage II Marginal Zone Lymphoma
  • Noncontiguous Stage II Small Lymphocytic Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Stage I Grade 1 Follicular Lymphoma
  • Stage I Grade 2 Follicular Lymphoma
  • Stage I Grade 3 Follicular Lymphoma
  • Stage I Marginal Zone Lymphoma
  • Stage I Small Lymphocytic Lymphoma
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Grade 3 Follicular Lymphoma
  • Stage III Marginal Zone Lymphoma
  • Stage III Small Lymphocytic Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Grade 3 Follicular Lymphoma
  • Stage IV Marginal Zone Lymphoma
  • Stage IV Small Lymphocytic Lymphoma
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263