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Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

This study has been terminated.
(discontinuation of the drug formulation used in the study)
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00644189
First received: March 24, 2008
Last updated: March 26, 2017
Last verified: March 2017
Results First Received: February 2, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Follicular Lymphoma
Marginal Zone Lymphoma
Mantle Cell Lymphoma
Small Lymphocytic Lymphoma
Lymphoplasmacytic Lymphoma
Low Grade B-cell Lymphoma, Not Otherwise Specified
Diffuse Large B-cell Lymphoma
Peripheral T-cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Anaplastic Large-cell Lymphoma
Intervention: Drug: Clofarabine

  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
Clofarabine 1 mg Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine 2 mg Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine 4 mg Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: 3 mg Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.

Participant Flow for 2 periods

Period 1:   Phase I
    Clofarabine 1 mg   Clofarabine 2 mg   Clofarabine 4 mg   Clofarabine: 3 mg
STARTED   3   3   6   18 
COMPLETED   3   3   6   18 
NOT COMPLETED   0   0   0   0 

Period 2:   Phase II
    Clofarabine 1 mg   Clofarabine 2 mg   Clofarabine 4 mg   Clofarabine: 3 mg
STARTED   0 [1]   0 [1]   0 [1]   50 [2] 
Completed All 6 Cycles of Treatment   0   0   0   19 
COMPLETED   0   0   0   50 
NOT COMPLETED   0   0   0   0 
[1] All phase I participants were included in the 3mg Phase II dose group
[2] Additional participants were added to the phase I sample at the phase II 3mg dose level



  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.
Phase I participants

Reporting Groups
  Description
Clofarabine Phase I

Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.

Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.


Baseline Measures
   Clofarabine Phase I 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 62 
 (47 to 88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  50.0% 
Male      15  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   30 
Number of prior regimens 
[Units: Number of prior regimens]
Median (Full Range)
 1 
 (1 to 7) 
Histologies 
[Units: Participants]
Count of Participants
 
follicular lymphoma (FL)      7  23.3% 
small lymphocytic lymphoma (SLL)      6  20.0% 
diffuse large B-cell lymphoma (DLBCL)      3  10.0% 
marginal zone lymphoma (MZL)      7  23.3% 
mantle cell lymphoma (MCL)      6  20.0% 
T-cell lymphoma (TCL)      0   0.0% 
lymphoplasmacytic lymphoma (LPL)      1   3.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   All Phase I-II Participants: Overall Response Rate (ORR)   [ Time Frame: after at most 6 28-day cycles ]

2.  Primary:   Phase I Participants Only: Overall Response Rate (ORR)   [ Time Frame: after at most 6 28-day cycles ]

3.  Secondary:   Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)   [ Time Frame: after at most 6 28-day cycles ]

4.  Secondary:   All Phase I-II Participants: Progression-free Survival (PFS)   [ Time Frame: at 1 and 2 years ]

5.  Secondary:   All Phase I-II Participants: Overall Survival (OS)   [ Time Frame: 3 years ]

6.  Secondary:   All Phase I-II Participants: Safety   [ Time Frame: during 6 28-day cycles and 90 days out ]

7.  Secondary:   Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)   [ Time Frame: after at most 6 28-day cycles ]

8.  Secondary:   Phase I Participants: Progression-free Survival (PFS)   [ Time Frame: at 17 months ]

9.  Secondary:   All Phase I Participants: Overall Survival (OS)   [ Time Frame: at 17 months ]

10.  Secondary:   Phase I Participants: Safety   [ Time Frame: during 6 28-day cycles and 90 days out ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeremy Abramson, MD
Organization: Massachusetts General Hospital Cancer Center
phone: 617-724-4000
e-mail: jabramson@mgh.harvard.edu



Responsible Party: Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00644189     History of Changes
Other Study ID Numbers: 07-401
Study First Received: March 24, 2008
Results First Received: February 2, 2017
Last Updated: March 26, 2017