Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Pixantrone

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

CPOP-R

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

CHOP-R

Gabor Jurida, M.D.

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.

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.

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

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

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.

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

CTI BioPharma

CPOP-R: 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-R: 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

Total

≤ 65 Years

>65 Years

Age, Customized

Sex: Female, Male

Caucasian

Hispanic

Black

Asian

Other

Race/Ethnicity, Customized

Anton Egorov, Associate Project Director Clinical Development

Complete Response

Complete Response Unconfirmed

Response Rate

Overall Survival

Median Progression Free Survival (PFS)

Overall Objective Response Rate

Time to Treatment Failure

Overall Study

Hodgkin Disease

Hodgkin Lymphoma

Vinorelbine

Patients are dosed on Day 1 and Day 8 of a 21-day cycle.

Patients are dosed on Day 1 of a 21-day cycle.

John Sarantopoulos, MD

Gerald Batist, MD

Anthony W. Tolcher, MD

This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.

The objectives of this study are:

* To assess the safety and tolerability of treatment with VLI.
* To determine the maximum tolerated dose (MTD) of VLI.
* To characterize the pharmacokinetic (PK) profile of VLI.
* To explore preliminary tumor response of VLI.

Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Spectrum Pharmaceuticals, Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin	NCT00268853	Diffuse Large-C...	CPOP-R CHOP-R	18 Years -	CTI BioPharma
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease	NCT00364676	Tumors Hodgkins Diseas... Non-Hodgkins Ly...	VLI VLI	18 Years -	Spectrum Pharmaceuticals, Inc

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