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Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01661881
First received: July 15, 2012
Last updated: November 15, 2016
Last verified: November 2016
Results First Received: September 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Interventions: Drug: Rituximab
Drug: Bendamustine
Drug: Cytarabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from August 2012 through March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RB/RC

Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:

  1. 2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
  2. 1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
  3. 1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity.

Participant Flow:   Overall Study
    RB/RC
STARTED   23 
COMPLETED   23 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RB/RC

Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:

  1. 2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
  2. 1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
  3. 1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity.

Baseline Measures
   RB/RC 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Median (Full Range)
 57 
 (42 to 69) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  34.8% 
Male      15  65.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   23 
MIPI at Diagnosis [1] 
[Units: Participants]
Count of Participants
 
Low   16 
Intermediate   5 
High   2 
[1] The MIPI (Mantle Cell Lymphoma international prognostic index) (Hoster et al, 2008) is a risk index based on clinical characteristics (eg, LDH, white blood count, etc). Patients with higher MIPI scores tend to have a worse prognosis with frontline therapy.


  Outcome Measures
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1.  Primary:   Complete Remission (CR) Rate After 6 Cycles   [ Time Frame: Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days. ]

2.  Secondary:   1 Year Progression-Free Survival   [ Time Frame: Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months. ]

3.  Secondary:   Autologous Stem Cell Transplant (ASCT) Rate   [ Time Frame: All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Philippe Armand MD, PhD
Organization: Dana-Farber Cancer Institute
phone: 617.632.2305
e-mail: Philippe_Armand@dfci.harvard.edu


Publications of Results:

Responsible Party: Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01661881     History of Changes
Other Study ID Numbers: 12-168
Study First Received: July 15, 2012
Results First Received: September 15, 2016
Last Updated: November 15, 2016