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

This study is currently recruiting participants.
Verified July 2012 by Cell Therapeutics

First Received on March 21, 2011.  
Last Updated on July 11, 2012  
History of Changes
This Clinical Trial Sponsored By: Cell Therapeutics
Information provided by (Responsible Party): Cell Therapeutics
ClinicalTrials.gov Identifier: NCT01321541
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial 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: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Rituximab

U.S. FDA Resources

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures For Clinical Trial:

  • 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 For Clinical Trial:

  • 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) in the intent-to-treat (ITT) population. Patients who withdraw from study without documented progression will be censored a the time of the last adequate disease assessment. Patient who complete the study, have not progressed, and are still alive at the cut-off date of the analysis will be censored at the last adequate disease assessment.

  • 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.

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 Study Interventions

Experimental: Pixantrone + Rituximab Drug: Pixantrone + Rituximab

Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 85 mg/m2 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

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

Contacts
Contact: Jack Singer, MD 1-800-215-2355

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