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Follicular LymphomaPhase 2MasterPlanNCT01130194

Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

A Phase 2 study testing Combination of treatment modalities in people with Follicular Lymphoma, run by St. Louis University 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

Follicular lymphoma has historically been considered an incurable lymphoma. By combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Follicular Lymphoma
What is being tested?
Combination of treatment modalities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
Jul 2006to Jun 2012
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years of age
  • Follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens
  • Relapse of disease must be greater than 6 months after last chemotherapy
  • Stages II, III or IV
  • Eastern Cooperative Group (ECOG) performance status of 0 or 1. If ECOG 2-4, poor performance must by due to lymphoma as judged by study investigator.
  • Patient signed written informed consent
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  • Adequate renal function defined as a glomerular filtration rate (GFR) > 60 ml/min
  • Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow.
  • No known allergies to the chemotherapeutic agents
  • No other major disabling co morbidities
  • Adequate pulmonary function, defined as corrected DLCO greater than 70% of predicted and FEV1 (forced expiratory volume in one second, a test of respiratory function) greater than 50% of predicted.
  • Adequate hepatic function as assessed by study investigator
  • Adequate cardiac function, defined as baseline MUGA (Multiple gated acquisition, a test of heart function) >50%

Who cannot join

  • Stage I follicular lymphoma
  • ECOG performance status ≥ 2, unless due to lymphoma
  • Patient refuses to sign written informed consent
  • Poor renal function defined as GFR <60ml/min
  • Abnormal liver function as assessed by study investigator
  • Poor bone marrow reserve (absolute neutrophil count <1,500 and/or platelets < 100,000) not attributable to lymphomatous involvement of the bone marrow.
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  • Hypersensitivity to the chemotherapeutic agents
  • Major disabling co morbidities like uncontrolled severe HTN (hypertension), active coronary artery disease, liver cirrhosis.
  • Previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed <5 years prior.
  • Central nervous system disease
  • History of advanced cardiac disease (Active angina, Congestive heart failure with a LVEF (left ventricular ejection fraction) <50%).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma

Follicular lymphoma has historically been considered an incurable lymphoma. By combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. The investigators goal is to have at least 60-70% of our patients in first continuous complete remission 15 years from initiation of treatment.

Read the detailed description

Patients will receive six cycles of combination chemotherapy, C-MOPP-R, typically through a subcutaneous PORT. This combination chemotherapy will last six months. After the last dose of chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem cell mobilization from peripheral blood with subcutaneous injections of neupogen and mozobil. Patients then receive Zevalin radioimmunotherapy, and this is followed after recovery of blood counts, typically 3 months later, by an autologous stem cell transplant.

Being tested
Combination of treatment modalities
Keywords
follicular lymphoma, radioimmunotherapy, rituximab, C-MOPP-R, autologous transplant
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • Combination of treatment modalitiesOther

    Also called Cytoxan, Rituxan, Oncovin, Matulane

    Intravenous cyclophosphamide, rituximab, and vincristine day 1 and 8 of 28 day cycles for 6 cycles total.

    Oral prednisone and procarbazine day 1-14 of every 28 day cycle. Yttrium ibritumomab tiuxetan intravenous injection. Autologous stem cell transplant with intravenous BEAM (BCNU or carmustine, etoposide, ara-C or cytarabine, melphalan) chemotherapy conditioning.

Study groups in NCT01130194
Study groupRoleWhat they receive
ExperimentalExperimentalC-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation
Receives: Other: Combination of treatment modalities

What is being measured

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

  1. Disease-free survival percentage(intention to treat)

    Measured: 5 years

Secondary outcomes (1)

  1. Incidence of second malignancies

    Measured: 5 years

Timeline

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

  1. First posted25 May 2010 (estimated)
  2. Study startJul 2006
  3. Primary completionJun 2012
  4. Study completionJun 2012

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130194
Sponsor's protocol ID
IRB #14228
Acronym
MasterPlan
Status last verified
May 2014
First submitted
24 May 2010
Last updated
12 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Fesler MJ, Osman M, Glauber J, Petruska PJ. C-MOPP: Results of a Forgotten Regimen in the Era of Rituximab and PET. Blood (ASH Annual Meeting Abstracts 2009) #4577.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combination of treatment modalities in people with Follicular Lymphoma, run by St. Louis University 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 13 inclusion and 11 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: finished, as of the sponsor's last update on 12 May 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disease-free survival percentage(intention to treat) (time frame: 5 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 NCT01130194, which also lists 1 linked publication.

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 12 May 2014.

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