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Lymphoma, B-CellPhase 2NCT00577629

Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

A Phase 2 study testing cyclophosphamide, etoposide and rituximab in people with Lymphoma, B-Cell, run by Duke 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

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
cyclophosphamide, etoposide and rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
18 Jun 2005to 3 Nov 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated, biopsy proven B-cell non-Hodgkin's lymphoma
  • Age >/= 18 years
  • No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.
  • Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

Who cannot join

  • Significant medical and/or psychiatric illness which may compromise planned treatment;
  • Pregnant or lactating;
  • HIV-infection.
  • Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Read the detailed description

This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Keywords
high risk non-hodgkins lymphoma, NHL, Bexxar, high dose chemotherapy
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • cyclophosphamideDrug

    Also called Cytoxan®

    1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

  • etoposideDrug

    Also called VP-16

    300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

  • rituximabDrug

    Also called Rituxan

    375mg/m2 each week x 4 weeks of induction, beginning on day 1

  • cytarabineDrug

    Also called Ara-C

    3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

  • doxorubicinDrug

    Also called Adriamycin

    45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

  • tositumomabDrug

    Also called Bexxar

    450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Study groups in NCT00577629
Study groupRoleWhat they receive
Induction + Consolidation + BexxarExperimentalInduction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)
Receives: Drug: cyclophosphamide; Drug: etoposide; Drug: rituximab; Drug: cytarabine; Drug: doxorubicin; Drug: tositumomab

What is being measured

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

  1. 1 Year Progression-free Survival Rate

    Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.

    Measured: 1 year

Secondary outcomes (4)

  1. Disease-free Survival

    Disease-free survival is measured from the date of CR or CRu to date of relapse or death

    Measured: 10 years

  2. Overall Survival

    Overall Survival is measured from the first day of chemotherapy until death from any cause.

    Measured: 10 years

  3. Overall Response

    Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.

    CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

    PR =

    1. >/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
    2. No increase should be observed in the size of other nodes, liver, or spleen.
    3. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
    4. Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
    5. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.
    6. No new sites of disease should be observed.

    Measured: up to 1 year

  4. Secondary Malignancies

    The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.

    Measured: 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 posted20 Dec 2007 (estimated)
  2. Study start18 Jun 2005
  3. Primary completion8 Apr 2012
  4. Study completion3 Nov 2016

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00577629
Sponsor's protocol ID
Pro00007096
Other IDs
GSK-103421, 5762
Status last verified
Apr 2017
First submitted
18 Dec 2007
Last updated
30 May 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, etoposide and rituximab in people with Lymphoma, B-Cell, run by Duke 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 4 inclusion and 4 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 30 May 2017. 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 15 Apr 2013). 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?

1 Year Progression-free Survival Rate (time frame: 1 year). 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 NCT00577629.

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 30 May 2017.

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