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LymphomaPhase 2NCT00521014

GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

A Phase 2 study testing filgrastim, rituximab and sargramostim in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop the growth of cancer cells by stopping them from dividing or by killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and sargramostim
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Oct 2007to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma
  • Achieved a complete or partial response to last salvage therapy
  • Completed salvage therapy within the past 12 weeks
  • No disease progression since last salvage therapy
  • One of the following disease statuses must have been present prior to receiving salvage therapy
  • Refractory to last anti-lymphoma therapy
  • Last remission duration less than 1½ years if salvage therapy is 3rd regimen
  • Last remission duration less than 3 years if salvage therapy is 2nd regimen
  • Minimum of 2 x 10^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem cell support
  • No leptomeningeal disease or brain parenchyma involvement

PATIENT CHARACTERISTICS:

  • Cardiac ejection fraction > 50%
  • If over 60 years of age, no evidence of cardiac ischemia by treadmill stress test (stress echo or sesta-MIBI)
  • Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function testing
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mL/min
  • ANC > 1,000/μL
  • Platelet count > 50,000/μL
  • Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected)
  • Not pregnant or breast-feeding
  • Fertile patients must use an acceptable form of birth control
  • HIV I or II negative
  • No acute or chronic hepatitis B
  • No active hepatitis C
  • No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that, in the opinion of the attending physician and/or principal investigator, would preclude study treatment
  • No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy
  • Biologic agents (e.g., monoclonal antibodies and vaccines) administered as part of a planned treatment regimen will not be considered distinct regimens
  • Chemotherapy administered primarily for the purpose of stem cell mobilization (e.g., cyclophosphamide at 2-4 g/m²) will not be considered an anti-lymphoma regimen
  • No prior autologous or allogeneic hematopoietic stem cell transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop the growth of cancer cells by stopping them from dividing or by killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may find any remaining cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving GM-CSF together with rituximab after autologous stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after autologous stem cell transplant works in treating patients with relapsed or primary refractory follicular non-Hodgkin lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the progression-free survival rate at 2 years after autologous stem cell transplantation (ASCT) in patients with relapsed or primary refractory follicular lymphoma treated with sargramostim (GM-CSF) and rituximab after ASCT.

Secondary

  • To assess the safety of administering GM-CSF and rituximab after ASCT.
  • To assess the effects of GM-CSF on the relative expression of activating and inhibitory FcγR on circulating monocytes.
  • To assess the effects of GM-CSF on the relative expression of activating and inhibitory FcγR on circulating dendritic cells.
  • To assess the effects of GM-CSF on the level of circulating FcγR.
  • To assess the reconstitution of NK cells, NK-T cells, dendritic cell subsets, and regulatory T-cells after ASCT.

OUTLINE:

  • High-dose chemotherapy: Patients receive carmustine IV over 2 hours on day -7, etoposide IV over 1 hour and cytarabine IV every 12 hours on days -6 to -3, and melphalan IV on day -2.
  • Autologous stem cell transplantation (ASCT): Patients undergo ASCT on day 0. Patients receive filgrastim (G-CSF) subcutaneously (SC) once a day beginning on day 5 and continuing until blood counts recover.
  • Sargramostim (GM-CSF) and rituximab: Beginning approximately 7-10 weeks (49-70 days) after ASCT, patients receive GM-CSF SC 3 times a week for 8 weeks and rituximab IV once weekly for 4 weeks (beginning within 3 days after the first dose of GM-CSF). Patients receive a second course of GM-CSF and rituximab (as above) beginning approximately 22-26 weeks (154-182 days) after ASCT.

After the completion of study treatment, patients are followed periodically for 2 years.

Conditions
Lymphoma
Being tested
filgrastim, rituximab, sargramostim, carmustine, cytarabine
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent 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.

Study groups in NCT00521014
Study groupRoleWhat they receive
GM-CSF and Rituximab After Autologous Stem Cell TransplantExperimentalGM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, administered on alternate days. Thus, 24 doses of GM-CSF will be administered. Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF; rituximab. The second course of GM-CSF and rituximab will be administered approximately 22-26 weeks (day +154 to +182) after ASCT.
Receives: Biological: filgrastim; Biological: rituximab; Biological: sargramostim; Drug: carmustine; Drug: cytarabine; Drug: etoposide; Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation

What is being measured

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

  1. Progression-free Survival Rate

    after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:

    1. ≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR
    2. appearance of any new lesions

    Measured: up to 3 years

Timeline

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

  1. First posted27 Aug 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2013
  4. Study completionJul 2013

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00521014
Sponsor's protocol ID
07-085
Other IDs
P30CA008748, MSKCC-07085, BRLX-MSKCC-07-085
Status last verified
Nov 2015
First submitted
24 Aug 2007
Last updated
22 Dec 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, rituximab and sargramostim in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center 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?

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: finished, as of the sponsor's last update on 22 Dec 2015. 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?

Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival Rate (time frame: up to 3 years). 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 NCT00521014.

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 22 Dec 2015.

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