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Diffuse Large-Cell LymphomaPhase 2RAPIDNCT00268853

A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin

A Phase 2 study testing CPOP-R and CHOP-R in people with Diffuse Large-Cell Lymphoma, run by CTI BioPharma at 75 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large-Cell Lymphoma
What is being tested?
CPOP-R and CHOP-R
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
75 sitesin 5 countries
Study dates
Nov 2005to May 2012
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

  • Previously untreated and histologically confirmed diffuse large B-cell lymphoma according to REAL/WHO classification.
  • Stage II, III or IV disease
  • CD20+
  • Age ≥ 18 years
  • ECOG performance status ≤ 2
  • At least one objectively bidimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion. Patients with the following sites of disease are NOT eligible:
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  • Patients with only skin lesions or only palpable lymph nodes.
  • Patients with spleen or bone marrow as only site of disease.
  • Life expectancy ≥ 3 months
  • Serum bilirubin ≤ 1.5 x the institution's upper limit normal (ULN) and creatinine ≤ 2.0 ULN and AST or ALT ≤ 2.0 x the institution's ULN. If hepatic involvement by lymphoma is present, AST or ALT may be ≤ 5.0 x the institution's ULN.
  • LVEF ≥ 50% determined by MUGA scan.
  • Ability to comply with the visit schedule and assessments required by the protocol.
  • Signed approved informed consent, with understanding of study procedures.

Who cannot join

  • Any prior chemotherapy (except intrathecal chemotherapy at diagnosis and pretreatment corticosteroid therapy) or radiotherapy: Patients may receive corticosteroid pretreatment therapy for up to 7 days after randomization, pending Investigator's decision to reduce tumor burden.
  • Histological diagnosis of T-cell lymphoma or any B-cell lymphoma other than diffuse large B-cell.
  • History of indolent lymphoma
  • Active CNS involvement based on clinical evaluation .
  • HIV-related lymphoma.
  • Major thoracic and/or abdominal surgery within the 4 weeks before randomization from which the patient has not fully recovered except for diagnosis of NHL. Patients who have had minor surgery may be enrolled after a ≥ 1 week recovery period except for diagnosis of NHL.
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  • Clinically significant cardiovascular abnormalities
  • Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.
  • Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B virus or resolved infection will not be excluded.
  • Active or history of another malignancy except cured basal cell carcinoma of skin or carcinoma in situ of uterine cervix. Patients who have been in remission from another previous malignancy for >5 years will be considered eligible.
  • Known hypersensitivity to the excipients or the study drugs that the patient will receive.
  • Any contraindications to the study drugs as described in the Summary of Product Characteristics or package inserts. 13. Neurological contraindication to vincristine (e.g. peripheral neuropathy).
  • 14. Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise unsuitable. 15. General status that, in the opinion of the Investigator does not permit the administration of eight courses of CHOP-R/CPOP-R. 16. Treatment with any other investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy. 17. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration.
  • 18. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Trial locations and contacts

75 sites in 5 countries.

75 sites in 5 countries

United States58 sites

  • Summa Health Systems Hospitals

    Akron, Ohio, 44304

  • New Mexico Hematology/Oncology Consultants

    Albuquerque, New Mexico, 87109

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Maryland Hematology/Oncology Associates, PA

    Baltimore, Maryland, 21237

  • Barberton Citizen's Hospital

    Barberton, Ohio, 44203

  • Our Lady of the Lake Regional Medial Center, Hematology Oncology

    Baton Rouge, Louisiana, 70808

  • Center for Cancer and Blood Disorders, P.C.

    Bethesda, Maryland, 20817

  • Cancer Treatment & Research Mid-Dakota Clinic

    Bismarck, North Dakota, 58501

  • The Center of Hematology and Oncology

    Boca Raton, Florida, 33486

  • Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research

    Boston, Massachusetts, 02111

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Oncology Partners Network

    Cincinnati, Ohio, 45257

  • The Family Cancer Center

    Collierville, Tennessee, 38017

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Columbus Clinic

    Columbus, Georgia, 39101

  • Bay Medical Oncology & Hematology

    Concord, California, 94520

  • Texas Hematology Oncology Center

    Dallas, Texas, 75234

  • Dayton Clinical Oncology Program

    Dayton, Ohio, 45429

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Frederick Memorial Hospital Cancer Center

    Frederick, Maryland, 21701

  • Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center

    Greenville, North Carolina, 27858

  • Oncology Hematology of Northern Illinois

    Gurnee, Illinois, 60031

  • Hazel Hawkins Hospital, Dept. of Medical Oncology

    Hollister, California, 95020

  • Capital Comprehensive Cancer Care

    Jefferson City, Missouri, 65109

  • Osceola Cancer Center

    Kissimmee, Florida, 34741

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division

    La Jolla, California, 92093

  • Watson Clinic for Cancer Care and Research

    Lakeland, Florida, 33805

  • Watson Clinic

    Lakeland, Florida, 33805

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Southeast Nebraska Hematology and Oncology Consultants, P.C.

    Lincoln, Nebraska, 68510

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Low County Hematology & Oncology

    Mt. Pleasant, South Carolina, 29464

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Cancer Care Center

    New Albany, Indiana, 47150

  • St. Luke's Roosevelt Hospital

    New York, New York, 10019

  • Mid-Illinois Hematology & Oncology Associates

    Normal, Illinois, 61761

  • Northern Utah Hematology Oncology, P.C.

    Ogden, Utah, 84403

  • Hematology/Oncology Group of Orange County

    Orange, California, 92868

  • Western Kentucky Hematology/Oncology Group

    Paducah, Kentucky, 42003

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33028

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Northwest Kaiser Permanente

    Portland, Oregon, 97227

  • Berks Hematology-Oncology Associates Ltd.

    Reading, Pennsylvania, 19612

  • Hubert H Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • Interlake Foundation, Inc.

    Rochester, New York, 14623

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Multicare Oncology Hematology Specialists

    Tacoma, Washington, 98405

  • Oncology Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Hematology Oncology Specialists

    Tampa, Florida, 33607

  • Jacobi Medical Center Phase I Oncology

    The Bronx, New York, 10461

  • Our Lady of Mercy Medical Center

    The Bronx, New York, 10466

  • North Missssppi Hematology Oncology Associates

    Tupelo, Mississippi, 38801

Other trials in United States

Italy7 sites

  • Instituto di Ematologia "Lorenzo e Ariosto"

    Bologna, 40138

  • Azienda Ospedaliera Careggi

    Florence, 50139

  • Farmacia Osepdaliera, Odpedale Umberto I

    Mestre, 30173

  • Ospedal V. Cervello

    Palermo, 90146

  • Uiversita La Sapienza

    Roma, 00161

  • Policlinico S. Maria alle Scotte

    Siena, 53100

  • Ospedale Civile

    Udine, 33100

Other trials in Italy

Germany5 sites

  • Klinikum der Universitaet zu Koeln

    Cologne, 50924

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Klinikum Nurnberg Nord - Medizinische

    Nuremberg, 90419

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Canada3 sites

  • Queen Elizabeth II HSC

    Halifax, NS B3H 1V8

  • London Health Science Center Regional Care Program

    London, Ontario, N6A4L6

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

Other trials in Canada

France2 sites

  • CHU Hotel Dieu

    Nantes, 44000

  • Hopitaux Universitaires de Strabourg - Hopital Hautepierre

    Strasbourg, 67200

Other trials in France

About this study

Official title: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

Read the detailed description

In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.

Being tested
CPOP-R, CHOP-R
Keywords
lymphoma, NHL, large cell, phase II, CHOP R, CPOP R, non Hodgkins
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma

What participants receive

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

  • CPOP-RDrug

    Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

  • CHOP-RDrug

    Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

Study groups in NCT00268853
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: CPOP-R
2Active comparatorNot described
Receives: Drug: CHOP-R

What is being measured

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

  1. Response Rate

    Measured: Subjects followed for 5 years post treatment

Secondary outcomes (4)

  1. Overall Survival

    Overall Survival time frame is from the interval between the date of randomization and death due to any cause and measures the total number of deaths.

    Measured: The interval between the date of randomization and death due to any cause (up to 100 weeks)

  2. Median Progression Free Survival (PFS)

    The interval between the date of randomization and the event of disease progression or relapse, institution of a new anticancer treatment or death.

    Measured: From the date of randomization to the first documented disease progression or death (up to 100 weeks)

  3. Overall Objective Response Rate

    Measured: Subjects followed for 5 years post treatment

  4. Time to Treatment Failure

    Measured: Subjects followed for 5 years post treatment

Timeline

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

  1. First posted23 Dec 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionMay 2012
  4. Study completionMay 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268853
Sponsor's protocol ID
PIX203
Acronym
RAPID
Status last verified
May 2024
First submitted
21 Dec 2005
Last updated
30 May 2024
Data monitoring committee
Yes

Publications

  • Herbrecht R, Cernohous P, Engert A, Le Gouill S, Macdonald D, Machida C, Myint H, Saleh A, Singer J, Wilhelm M, van der Jagt R. Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma. Ann Oncol. 2013 Oct;24(10):2618-2623. doi: 10.1093/annonc/mdt289. Epub 2013 Aug 14.

    PubMed 23946328

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPOP-R and CHOP-R in people with Diffuse Large-Cell Lymphoma, run by CTI BioPharma at 75 sites in 5 countries.

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 14 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 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Italy, Germany, Canada, France. 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 30 May 2024). 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?

Response Rate (time frame: Subjects followed for 5 years post treatment). 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 NCT00268853, 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 30 May 2024.

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