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Vorinostat, Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT00918723
Recruitment Status : Active, not recruiting
First Posted : June 11, 2009
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mazyar Shadman, Fred Hutchinson Cancer Research Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage I Small Lymphocytic Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage II Small Lymphocytic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Small Lymphocytic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Small Lymphocytic Lymphoma
Interventions: Drug: Fludarabine Phosphate
Drug: Cyclophosphamide
Biological: Rituximab
Drug: Vorinostat

  Participant Flow

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
Treatment (Induction and Maintenance Chemotherapy)

INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.

Fludarabine Phosphate: Given IV

Cyclophosphamide: Given IV

Rituximab: Given IV

Vorinostat: Given PO


Participant Flow:   Overall Study
    Treatment (Induction and Maintenance Chemotherapy)
STARTED   40 
COMPLETED   40 
NOT COMPLETED   0 



  Baseline Characteristics

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
Treatment (Induction and Maintenance Chemotherapy)

INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.

Fludarabine Phosphate: Given IV

Cyclophosphamide: Given IV

Rituximab: Given IV

Vorinostat: Given PO


Baseline Measures
   Treatment (Induction and Maintenance Chemotherapy) 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Mean (Full Range)
 58 
 (36 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  20.0% 
Male      32  80.0% 
Rai stage at the time of diagnosis [1] 
[Units: Participants]
Count of Participants
 
Rai stage 0      15  37.5% 
Rai stage I/II      19  47.5% 
Rai stage III/IV      6  15.0% 
[1] Rai stage 0: Lymphocytosis in blood or bone marrow Rai stage I: Lymphocytosis + enlarged lymph nodes. Rai stage II: Lymphocytosis + enlarged liver or spleen with or without lymphadenopathy Rai stage III: Lymphocytosis + anemia (Hgb <11 g/dL) with or without enlarged liver, spleen, or lymph nodes Rai stage IV: Lymphocytosis + thrombocytopenia (platelet count <100,000/microL) with or without anemia or enlarged liver, spleen, or lymph nodes Low risk: Rai stage 0 Intermediate risk: Rai stages I and II High risk: Rai stages III and IV With higher risk, median survival outlook declines.
Rai stage at the time of treatment [1] 
[Units: Participants]
Count of Participants
 
Rai stage 0      0   0.0% 
Rai stage I/II      23  57.5% 
Rai stage III/IV      17  42.5% 
[1] Rai stage 0: Lymphocytosis in blood or bone marrow Rai stage I: Lymphocytosis + enlarged lymph nodes. Rai stage II: Lymphocytosis + enlarged liver or spleen with or without lymphadenopathy Rai stage III: Lymphocytosis + anemia (Hgb <11 g/dL) with or without enlarged liver, spleen, or lymph nodes Rai stage IV: Lymphocytosis + thrombocytopenia (platelet count <100,000/microL) with or without anemia or enlarged liver, spleen, or lymph nodes Low risk: Rai stage 0 Intermediate risk: Rai stages I and II High risk: Rai stages III and IV With higher risk, median survival outlook declines.
Time to treatment 
[Units: Months]
Mean (Full Range)
 27 
 (0 to 102) 
B symptoms [1] 
[Units: Participants]
Count of Participants
 13 
[1] B symptoms include weight loss, extreme fatigue, fevers, night sweats
del 17p (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 2 
del 11q (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 2 
Trisomy 12 (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 4 
del 13q (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 3 
Normal cytogenetic (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 14 
Other chromosomal abnormalities (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 6 
High CD38 expression (> 30%) (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 20 
High ZAP-70 (> 20%) (Cytogenetics/immunophenotypic characteristics) 
[Units: Participants]
Count of Participants
 14 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)   [ Time Frame: 28 days ]

2.  Primary:   Percentage of Patients With Progression-free Survival at 2 Years   [ Time Frame: 2 years ]

3.  Primary:   Overall Survival   [ Time Frame: 2 years ]

4.  Secondary:   To Eliminate Residual Disease (Documented by Flow Cytometry and/or Polymerase Chain Reaction [PCR]) in Patients Who Have Achieved Complete Response (CR) After Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Vorinostat   [ Time Frame: Within 21 days prior to starting maintenance therapy ]

5.  Secondary:   To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat   [ Time Frame: After completion of maintenance therapy (24 months after start of maintenance) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Dr. Mazyar Shadman
Organization: Fred Hutchinson Cancer Research Center
phone: 2066675467 ext 206
e-mail: mshadman@fredhutch.org



Responsible Party: Mazyar Shadman, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00918723     History of Changes
Other Study ID Numbers: PSOC 2401
NCI-2010-00324 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PSOC 2401 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: June 9, 2009
First Posted: June 11, 2009
Results First Submitted: October 31, 2017
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018