Trial record 1 of 1 for:    NCT 01321541
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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 (PIX-R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by CTI BioPharma
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT01321541
First received: March 21, 2011
Last updated: July 22, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
de Novo DLBCL
DLBCL Transformed From Indolent Lymphoma
Follicular Grade 3 Lymphoma
Drug: Pixantrone + Rituximab
Drug: Gemcitabine + Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • Overall Survival Analysis [ Time Frame: Randomization through death ] [ Designated as safety issue: No ]
    OS is defined as the time from randomization until death due to any cause.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to death. ] [ Designated as safety issue: No ]
    PFS is defined as the time of randomization to the date of PD or death due to any cause (whichever is first reported)

  • Complete Response Rate [ Time Frame: From randomization to death ] [ Designated as safety issue: No ]
    CRR is defined as the proportion of patients who achieve a CR without additional therapy.

  • Overall Response Rate [ Time Frame: From randomization to death ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.

  • Safety Evaluation [ Time Frame: From randomization to death ] [ Designated as safety issue: No ]
    The assessment of safety will be mainly on the frequency of adverse events and on the number of laboratory values that fall outside of predetermined ranges.


Estimated Enrollment: 350
Study Start Date: April 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pixantrone + Rituximab Drug: 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.
Active Comparator: Gemcitabine + Rituximab Drug: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
  2. Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL. Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent lymphoma must have received at least 1-4 treatment regimens for NHL.
  3. Received rituximab containing a multi-agent therapy for the treatment of NHL.
  4. Not eligible for high-dose chemotherapy and stem cell transplant.
  5. Response to NHL treatment for patients with DLBCL transformed from indolent lymphoma.

Exclusion Criteria:

  1. Primary refractory de novo DLBCL and primary refractory follicular grade 3 lymphoma.
  2. Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
  3. Any experimental therapy ≤ 28 days prior to randomization
  4. Other malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resection
  5. Any contraindication or known allergy or hypersensitivity to any study drugs
  6. Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321541

Contacts
Contact: Jim Dean, MD PhD 1-800-215-2355

  Show 59 Study Locations
Sponsors and Collaborators
CTI BioPharma
  More Information

Additional Information:
No publications provided

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT01321541     History of Changes
Other Study ID Numbers: PIX306 (PIX-R Trial)
Study First Received: March 21, 2011
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
non-hodgkin lymphoma
DLBCL
relapsed
aggressive NHL
Diffuse large B-cell lymphoma
Rituximab
Rituxan
Pixantrone
NHL
non hodgkin's lymphoma
de novo DLBCL
DLBCL transformed from Indolent Lymphoma
Follicular Grade 3 Lymphoma

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Pixantrone
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014