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S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

This study has been terminated.
(toxicity in one arm)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01412879
First received: August 6, 2011
Last updated: May 4, 2017
Last verified: May 2017
Results First Received: February 15, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: rituximab
Drug: bendamustine hydrochloride
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate

  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
No text entered.

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
Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
Arm 2: R-Bendamustine (Induction Therapy) R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
Consolidation Therapy: Stem Cell Transplant

Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.

TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.


Participant Flow for 2 periods

Period 1:   Initial Registration (Induction Therapy)
    Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)   Arm 2: R-Bendamustine (Induction Therapy)   Consolidation Therapy: Stem Cell Transplant
STARTED   18   35   0 
Treatment Started   17   35   0 
COMPLETED   5   27   0 
NOT COMPLETED   13   8   0 
Adverse Event                5                3                0 
Refusal Unrelated to Adverse Event                1                3                0 
Progression/Relapse                0                1                0 
Reasons not Protocol Specified                6                1                0 
Treatment not Given                1                0                0 

Period 2:   Consolidation Therapy
    Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)   Arm 2: R-Bendamustine (Induction Therapy)   Consolidation Therapy: Stem Cell Transplant
STARTED   0   0   26 [1] 
COMPLETED   0   0   26 
NOT COMPLETED   0   0   0 
[1] Only eligible patients who are able to have stem cell harvested receive consolidation therapy.



  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.
All eligible patients who started treatment were included in the analysis

Reporting Groups
  Description
Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
Arm 2: R-Bendamustine (Induction Therapy) R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
Total Total of all reporting groups

Baseline Measures
   Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)   Arm 2: R-Bendamustine (Induction Therapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   35   52 
Age 
[Units: Years]
Median (Full Range)
 58.8 
 (43.6 to 65.7) 
 56.6 
 (33.0 to 64.1) 
 57.2 
 (33.0 to 65.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  47.1%      3   8.6%      11  21.2% 
Male      9  52.9%      32  91.4%      41  78.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      16  94.1%      35 100.0%      51  98.1% 
Unknown or Not Reported      1   5.9%      0   0.0%      1   1.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   5.9%      0   0.0%      1   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   5.9%      2   5.7%      3   5.8% 
White      13  76.5%      32  91.4%      45  86.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2  11.8%      1   2.9%      3   5.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS) at 2 Years   [ Time Frame: Up to 2 years ]

2.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 8 months (Assessed at the beginning of each cycle of treatment, at restaging, and at post transplant.) ]

3.  Secondary:   Response Rate (Complete and Partial Response)   [ Time Frame: Up to 9 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 2 years ]


  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
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  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: Lymphoma Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01412879     History of Changes
Other Study ID Numbers: CDR0000707601
S1106 ( Other Identifier: SWOG )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: August 6, 2011
Results First Received: February 15, 2017
Last Updated: May 4, 2017