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Stage III Grade 1 Follicular LymphomaPhase 2NCT00301795

Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

A Phase 2 study testing oblimersen sodium, rituximab and laboratory biomarker analysis in people with Stage III Grade 1 Follicular Lymphoma and Stage III Grade 2 Follicular Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
oblimersen sodium, rituximab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Mar 2006to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

Other trials in United States

About this study

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

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Oblimersen may help rituximab work better by making cancer cells more sensitive to the drug. This phase II trial is studying how well giving rituximab together with oblimersen works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
oblimersen sodium, rituximab, laboratory biomarker analysis
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oblimersen sodiumBiological

    Also called augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense

    Given IV

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00301795
Study groupRoleWhat they receive
Treatment (oblimersen sodium and rituximab)ExperimentalInduction 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.
Receives: Biological: oblimersen sodium; Biological: rituximab; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 12 months

Secondary outcomes (4)

  1. Toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Will be summarized using frequency tables.

    Measured: Up to 10 years

  2. Time-to-progression (TTP)

    Kaplan-Meier method will be used.

    Measured: Up to 10 years

  3. Time-to-best response

    Kaplan-Meier method will be used.

    Measured: Up to 10 years

  4. Overall survival

    Kaplan-Meier method will be used.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301795
Sponsor's protocol ID
NCI-2012-03080
Other IDs
CALGB 50404, U10CA031946, CDR0000462385
Status last verified
Jan 2013
First submitted
9 Mar 2006
Last updated
7 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oblimersen sodium, rituximab and laboratory biomarker analysis in people with Stage III Grade 1 Follicular Lymphoma and Stage III Grade 2 Follicular Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.

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