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LymphomaPhase 2NCT00896519

GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma

A Phase 2 study testing rituximab, sargramostim and cyclophosphamide in people with Lymphoma, run by French Innovative Leukemia Organisation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: 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
Conditions the study is for
Lymphoma
What is being tested?
rituximab, sargramostim and cyclophosphamide
How many people
30 participants
Where
No sites listed yet
Study dates
Mar 2009to Mar 2011
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular non-Hodgkin lymphoma
  • Grade 1-3a disease
  • Advanced disease
  • Has undergone initial lymph node biopsy within the past 4 months
  • At least 1 measurable lesion
  • Bulky disease, as defined by the following GELF criteria:
  • Nodal or extranodal mass > 7 cm in its greatest diameter
  • Involvement of ≥ 3 nodal sites (each with a diameter > 3 cm)
  • B symptoms
  • Elevated serum LDH or β2-microglobulin
  • Splenic enlargement
  • Compression syndrome
  • Pleural and/or peritoneal effusion
  • No transformation to high-grade follicular lymphoma (secondary to low-grade follicular lymphoma)
  • No prior or concurrent CNS disease (i.e., CNS lymphoma or lymphomatous meningitis) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,000/mm^3*
  • Platelet count ≥ 100,000/mm^3*
  • Hemoglobin ≥ 8.0 g/dL*
  • Total bilirubin ≤ 2.0 mg/dL*
  • AST ≤ 3 times upper limit of normal*
  • Serum creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No known HIV infection
  • No active hepatitis B or C infection
  • No serious underlying medical condition that would preclude study participation (e.g., ongoing infection, uncontrolled diabetes mellitus, gastric ulcer, active autoimmune disease, or heart failure)
  • No known sensitivity or allergy to murine products
  • No other prior or concurrent malignancies except nonmelanoma skin cancer or adequately treated in situ cervical cancer
  • No other co-existing medical or psychological condition that would preclude study participation or ability to give informed consent NOTE: *Unless abnormalities are related to lymphoma

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment for follicular lymphoma, including steroids or radiotherapy
  • More than 4 weeks since prior corticosteroids unless administered at a dose equivalent to < 20 mg/day of prednisone
  • More than 28 days since prior major surgery (excluding lymph node biopsy)
  • More than 30 days since prior treatment in a clinical trial

About this study

Official title: An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Antitumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With RCHOP Chemotherapy and Rituximab (MabThera®) Maintenance in Patients With First-line Advanced Follicular Non Hodgkin's Lymphoma

RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make more blood cells and help it recover from the side effects of rituximab and combination chemotherapy.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and combination chemotherapy works in treating patients with previously untreated advanced follicular non-Hodgkin lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the overall objective tumor response rate (complete and partial response rates) in patients with previously untreated advanced follicular non-Hodgkin lymphoma treated with sargramostim (GM-CSF) and R-CHOP.

Secondary

  • To evaluate the time to progression.
  • To evaluate the overall survival.
  • To evaluate the duration of response.
  • To evaluate the time to next treatment.
  • To evaluate the safety profile of GM-CSF in combination with R-CHOP.
  • To evaluate the influence of FcγR polymorphisms on clinical response.
  • To monitor FcγR expressing cells in peripheral blood during treatment.
  • To monitor the molecular biological marker bcl-2 [t(14;18)] in peripheral blood and bone marrow by quantitative PCR assay.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and oral prednisone on days 1-5. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) on days 2-6. Treatment repeats every 21 days for up to 6 courses. Patients then receive rituximab IV on day 1 and GM-CSF SC on days 1-5. Treatment with rituximab and GM-CSF repeats every 21 days for 2 courses. Patients achieving complete or partial response proceed to maintenance therapy.
  • Maintenance therapy: Patients receive rituximab IV on day 1 and GM-CSF SC on days 1-5. Treatment repeats every 2 months for 12 courses.

Blood and bone marrow samples are collected at baseline and periodically during study for analysis of FcγR expression by immunophenotyping and bcl-2 rearrangement by quantitative PCR.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Conditions
Lymphoma
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
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

What is being measured

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

  1. Overall objective tumor response rate

Secondary outcomes (8)

  1. Time to treatment progression

  2. Overall survival

  3. Duration of response

  4. Time to next treatment

  5. Safety profile

  6. Influence of FcγR polymorphisms on clinical response and overall survival

  7. Monitoring of FcγR expressing cells during treatment

  8. Quantitative monitoring of the molecular biological marker bcl-2 in peripheral blood and bone marrow by PCR assay

Timeline

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

  1. First posted11 May 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2011 (estimated)

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
Non-randomised
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00896519
Sponsor's protocol ID
GOELAMS-FL2008-RCHOP-GM
Other IDs
CDR0000637105, FL2008-RCHOP-GM, EUDRACT2007-007056-33, RECF0907
Status last verified
Jul 2009
First submitted
8 May 2009
Last updated
2 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, sargramostim and cyclophosphamide in people with Lymphoma, run by French Innovative Leukemia Organisation.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

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?

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 objective tumor response rate. 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 NCT00896519.

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 2 Aug 2013.

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