Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Aggression

Lymphoma, Non-Hodgkin

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Gemcitabine

Rituximab

Pixantrone

Antineoplastic Agents, Immunological

Immunologic Factors

Antimetabolites

Enzyme Inhibitors

Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Pixantrone + Rituximab

Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Gemcitabine + Rituximab

Simran B Singh, MS, GWCP

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods.

Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period.

Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period.

Survival Follow-Up: All patients will be monitored for survival.

Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

To characterize the PK profile of pixantrone when co-administered with rituximab. Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient. The goal is to enroll approx. 20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni. Hospital Kralovske Vinohrady, Uni. Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology \& Transfusiology, UMHAT "SV. IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology \& Transfusion Medicine, Uni. Hospital Martin, National Onclogy Inst., Uni. Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni. Hospital J.A. Reiman Presov

PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)

Overall survival is from randomization to death due to any cause

CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy. CR is defined as the disappearance of all target lesions.

ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.

The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)

CTI BioPharma

Safety will be assessed by monitoring and recording adverse events, serious adverse events, cardiac, hematologic and blood chemistry parameters, vital signs, performance status, and any abnormal findings observed on physical examinations

Pixantrone and Rituximab

Pixantrone + Rituximab: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Gemcitabine and Rituximab

Gemcitabine + Rituximab: Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

International Prognostic Index (IPI) Score Calculation:

IPI Points Characteristic:

1pt - Age \> 60 years

1pt - Performance Status 2, 3 or 4

1pt - NHL Stage III or IV

1pt - Elevated LDH

1pt - More than 1 extranodal site

Maximum Score Possible: 5

IPI Score 0-2 = better outcome IPI Score 3 or greater = worse outcome

IPI Score

Ann Arbor Staging System I = Involvement of a single lymph node or a single extranodal organ/site, II = Involvement of ≥ 2 lymph node regions on the same side of the diaphragm, or localized involvement of an extranodal site/organ, III = Involvement of lymph node regions on both sides of the diaphragm, which may be also accompanied by local involvement of an extranodal organ/site, IV = Diffuse or disseminated involvement of one or more distant extranodal organs with or without associated lymph node involvement I-III = better outcome, IV = worse outcome

Spots Global Cancer Trial Database for follicular grade 3 lymphoma