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A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma

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Trial Information

A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)


PRIMARY OBJECTIVES:

I. To determine the response rate (overall and complete response rate) after rituximab +
oblimersen sodium extended induction therapy in previously untreated cluster of
differentiation 20 positive (CD20+) follicular non-Hodgkin lymphoma (NHL) patients.

II. To determine the time to progression after rituximab + oblimersen sodium extended
induction therapy in previously untreated CD20+ follicular NHL patients.

SECONDARY OBJECTIVES:

I. To determine the toxicity profile of rituximab + oblimersen sodium therapy in previously
untreated CD20+ follicular NHL patients.

II. To establish whether the therapeutic effects of the rituximab + oblimersen sodium
combination are sufficiently promising to warrant evaluation in a subsequent randomized
trial (in comparison to rituximab alone).

III. To correlate Fc receptor profiling to response to rituximab + oblimersen sodium in
previously untreated patients with follicular NHL.

IV. To determine the relationship between change in fludeoxyglucose F 18 (FDG) uptake early
after treatment with rituximab + oblimersen sodium to response rate and time to progression.

OUTLINE: This is a multicenter study.

Induction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and
15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1.

Extended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV
continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9.

Treatment continues for 9 months in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.


Inclusion Criteria:



- Previously untreated, histologically confirmed follicular lymphoma, WHO
classification, grade 1, 2, or 3a (> 15 centroblasts per high power field with
centrocytes present) which is stage III, IV, or bulky (i.e., single mass >= 7 cm in
any unidimensional measurement) stage II

- Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen
expression

- Patients classified as high risk according to the Follicular Lymphoma International
Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016

- No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or
immunotherapy (e.g., monoclonal antibody-based therapy)

- No corticosteroids within two weeks prior to study, except for maintenance therapy
for a non-malignant disease

- ECOG performance status 0-2

- Measurable disease must be present either on physical examination or imaging studies;
non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable;
lesions that are considered non-measurable include the following:

- Bone lesions (lesions if present should be noted)

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow (involvement by non-Hodgkin lymphoma should be noted)

- No known CNS involvement by lymphoma

- No known HIV infection

- Non-pregnant and non-nursing; women and men of reproductive potential should agree to
use an effective means of birth control throughout their participation in this study;
appropriate methods of birth control include oral contraceptives, implantable
hormonal contraceptives, or double barrier method (diaphragm plus condom)

- Patients with a "currently active" second malignancy, other than nonmelanoma skin
cancers are not eligible; (this includes Waldenstrom's Macroglobulinemia, since such
patents have experienced transient increases in IgM following initiation of
rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis);
patients are not considered to have a "currently active" malignancy if they have
completed anti-cancer therapy, and are considered by their physician to be at less
than 30% risk of relapse

- ANC >= 1000/uL

- Platelet count >= 50,000/uL

- Creatinine =< 2 x ULN

- Total bilirubin =< 2 x ULN; unless attributable to Gilbert's disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response

Outcome Description:

The true OR rate will be estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 95% exact confidence interval for the true OR rate of each arm reflecting the above two-stage design.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Barbara Grant

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03080

NCT ID:

NCT00301795

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Grade 3 Follicular Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Grade 3 Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606