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Trial record 35 of 399 for:    Lymphoma AND (women OR woman OR female)

Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01661881
Recruitment Status : Active, not recruiting
First Posted : August 10, 2012
Results First Posted : January 12, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute

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
Enrollment 23
Recruitment Details Patients enrolled from August 2012 through March 2014.
Pre-assignment Details  
Arm/Group Title RB/RC
Hide Arm/Group Description

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.
Period Title: Overall Study
Started 23
Completed 22
Not Completed 1
Reason Not Completed
Disease Progression             1
Arm/Group Title RB/RC
Hide Arm/Group Description

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.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
57
(42 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
8
  34.8%
Male
15
  65.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
 100.0%
MIPI at Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Low
16
  69.6%
Intermediate
5
  21.7%
High
2
   8.7%
[1]
Measure Description: 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.
1.Primary Outcome
Title Complete Remission (CR) Rate After 6 Cycles
Hide Description The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Arm/Group Title RB/RC
Hide Arm/Group Description:

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. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
.96
(.81 to 1.0)
2.Secondary Outcome
Title 1 Year Progression-Free Survival
Hide Description 1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Arm/Group Title RB/RC
Hide Arm/Group Description:

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. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: probability
.96
(.73 to .99)
3.Secondary Outcome
Title Autologous Stem Cell Transplant (ASCT) Rate
Hide Description ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RB/RC
Hide Arm/Group Description:

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. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
.91
(.75 to .98)
Time Frame Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
 
Arm/Group Title RB/RC
Hide Arm/Group Description

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.

Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.

All-Cause Mortality
RB/RC
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RB/RC
Affected / at Risk (%)
Total   15/23 (65.22%) 
Blood and lymphatic system disorders   
Anemia  1  3/23 (13.04%) 
Febrile neutropenia  1  4/23 (17.39%) 
Thrombotic thrombocytopenic purpura  1  1/23 (4.35%) 
General disorders   
Fever  1  2/23 (8.70%) 
Infections and infestations   
Sepsis  1  1/23 (4.35%) 
Infections and infestations - Other  1  1/23 (4.35%) 
Investigations   
Lymphocyte count decreased  1  11/23 (47.83%) 
Neutrophil count decreased  1  8/23 (34.78%) 
Platelet count decreased  1  2/23 (8.70%) 
White blood cell decreased  1  3/23 (13.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RB/RC
Affected / at Risk (%)
Total   23/23 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  12/23 (52.17%) 
Febrile neutropenia  1  1/23 (4.35%) 
Eye disorders   
Eye disorders - Other  1  1/23 (4.35%) 
Gastrointestinal disorders   
Constipation  1  3/23 (13.04%) 
Diarrhea  1  1/23 (4.35%) 
Esophageal pain  1  1/23 (4.35%) 
Mucositis oral  1  1/23 (4.35%) 
Nausea  1  7/23 (30.43%) 
Vomiting  1  1/23 (4.35%) 
Gastrointestinal disorders - Other  1  2/23 (8.70%) 
General disorders   
Edema limbs  1  1/23 (4.35%) 
Fatigue  1  19/23 (82.61%) 
Fever  1  2/23 (8.70%) 
Infusion related reaction  1  2/23 (8.70%) 
Irritability  1  1/23 (4.35%) 
Pain  1  2/23 (8.70%) 
General disorders and administration site conditions - Other  1  1/23 (4.35%) 
Immune system disorders   
Immune system disorders - Other  1  1/23 (4.35%) 
Infections and infestations   
Mucosal infection  1  1/23 (4.35%) 
Infections and infestations - Other  1  2/23 (8.70%) 
Investigations   
Alkaline phosphatase increased  1  1/23 (4.35%) 
Aspartate aminotransferase increased  1  1/23 (4.35%) 
Neutrophil count decreased  1  6/23 (26.09%) 
Platelet count decreased  1  10/23 (43.48%) 
White blood cell decreased  1  3/23 (13.04%) 
Investigations - Other  1  1/23 (4.35%) 
Metabolism and nutrition disorders   
Anorexia  1  1/23 (4.35%) 
Hyperglycemia  1  1/23 (4.35%) 
Hyponatremia  1  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/23 (4.35%) 
Nervous system disorders   
Headache  1  4/23 (17.39%) 
Psychiatric disorders   
Insomnia  1  3/23 (13.04%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/23 (4.35%) 
Dyspnea  1  1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  2/23 (8.70%) 
Pruritus  1  5/23 (21.74%) 
Skin and subcutaneous tissue disorders - Other  1  4/23 (17.39%) 
Vascular disorders   
Hypotension  1  1/23 (4.35%) 
Phlebitis  1  1/23 (4.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
Responsible Party: Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01661881     History of Changes
Other Study ID Numbers: 12-168
First Submitted: July 15, 2012
First Posted: August 10, 2012
Results First Submitted: September 15, 2016
Results First Posted: January 12, 2017
Last Update Posted: September 6, 2018