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Trial record 9 of 42 for:    LENALIDOMIDE AND Leukemia AND SLL

Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT00602836
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : April 11, 2012
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: Rituximab
Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Pentostatin
Enrollment 45
Recruitment Details Forty-five (45) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between March 2009 and December 2009.
Pre-assignment Details One participant was deemed ineligible and is excluded from all analyses per study design.
Arm/Group Title PCR-Lenalidomide
Hide Arm/Group Description Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
Period Title: Overall Study
Started 44
Completed 39
Not Completed 5
Arm/Group Title PCR-Lenalidomide
Hide Arm/Group Description Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
65
(44 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
13
  29.5%
Male
31
  70.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
Fluorescence In Situ Hybridization (FISH) Abnormalities   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
deletion(13q14.2) 13
Trisomy 12 7
deletion (11q22) 6
17p- 1
Other 2
Normal 15
[1]
Measure Description: This test determines the presence of abnormalities in specific chromosomes of CLL cells, which are associated with more or less aggressive forms of cancer. Patients with abnormalities of chromosome 11 (deletion 11q23) and 17 (deletion 17p13) experience rapid progression of their CLL.
Rai Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Stage I-II 27
Stage III-IV 17
[1]
Measure Description: Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity. > Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis and lymphadenopathy, Rai Stage II: Lymphocytosis and hepatomegaly +/- splenomegaly, Rai Stage III: Lymphocytosis and anemia, Rai Stage IV: Lymphocytosis and thrombocytopenia
ZAP-70 Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Positive (>=20%) 24
Negative (<20%) 20
[1]
Measure Description: This test is used to predict the rate of progression from diagnosis to need for treatment in CLL. Participants with positive ZAP-70 (>=20%) tend to experience a more aggressive course of CLL.
CD38 Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Positive (>=30%) 14
Negative (<30%) 30
[1]
Measure Description: This test is used to predict the rate of progression from diagnosis to need for treatment in CLL. Participants with positive CD38 (>=30%) tend to experience a more aggressive course of CLL.
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Unmutated 22
Mutated 20
Not tested 2
[1]
Measure Description: IGVH testing helps predict which patients will experience a more aggressive (if the gene is unmutated, <=2%) or less aggressive (if the gene is mutated, >2%) course of CLL. This technically complex test is only available at select medical institutions.
1.Primary Outcome
Title Number of Participants With Complete Response (CR)
Hide Description

A complete response, as defined by the National Cancer Institute Working Group (NCIWG), requires all of the following for a period of at least 2 months:

- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCR-Lenalidomide
Hide Arm/Group Description:
Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: participants
14
2.Secondary Outcome
Title Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide
Hide Description

According to the NCIWG criteria, response is defined as follows:

nPR: Meets all criteria for CR, as described above, except the presence of residual clonal nodules in the bone marrow PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions SD: participant who does not meet any of the criteria described above

Time Frame 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide
Hide Description MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells to determine if there was any MRD.
Time Frame 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Number of Participants Who Convert From a CR With MRD or nPR, PR, or Stable Disease With Residual Disease After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants With a Response (CR, nPR, PR)
Hide Description Response criteria described in above outcomes
Time Frame During treatment (up to 5 years)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.
Time Frame time from registration to death (up to 5 years)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median TTP with 95% CI was estimated using the Kaplan Meier method.
Time Frame time from registration to progression (up to 5 years)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Number of Participants With IgVH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).
Hide Description Response categories described in above outcome measures. IgVH mutation status describe in baseline characteristics section.
Time Frame During treatment (up to 5 years)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Participants With CD38 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).
Hide Description Response categories described in above outcome measures. CD38 status described in baseline characteristics section.
Time Frame During treatment (up to 5 years)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Number of Participants With ZAP-70 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).
Hide Description Response categories described in above outcome measures. ZAP-70 status describe in baseline characteristics section.
Time Frame During treatment (up to 5 years)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants With FISH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).
Hide Description Response categories described in above outcome measures. FISH status describe in baseline characteristics section.
Time Frame During treatment (up to 5 years)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCR-Lenalidomide
Hide Arm/Group Description Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
All-Cause Mortality
PCR-Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PCR-Lenalidomide
Affected / at Risk (%) # Events
Total   9/44 (20.45%)    
Cardiac disorders   
Atrial flutter  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Nausea  1  1/44 (2.27%)  1
Infections and infestations   
Upper airway infection  1  1/44 (2.27%)  1
Urinary tract infection  1  1/44 (2.27%)  1
Investigations   
Neutrophil count decreased  1  4/44 (9.09%)  6
Platelet count decreased  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  2/44 (4.55%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PCR-Lenalidomide
Affected / at Risk (%) # Events
Total   44/44 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  40/44 (90.91%)  231
Febrile neutropenia  1  1/44 (2.27%)  1
Cardiac disorders   
Atrial fibrillation  1  2/44 (4.55%)  2
Atrial flutter  1  1/44 (2.27%)  1
Left ventricular failure  1  1/44 (2.27%)  4
Restrictive cardiomyopathy  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/44 (2.27%)  1
Abdominal pain  1  1/44 (2.27%)  1
Constipation  1  1/44 (2.27%)  1
Diarrhea  1  2/44 (4.55%)  2
Flatulence  1  1/44 (2.27%)  1
Nausea  1  6/44 (13.64%)  11
Small intestinal obstruction  1  1/44 (2.27%)  1
Vomiting  1  4/44 (9.09%)  8
General disorders   
Chills  1  4/44 (9.09%)  4
Edema limbs  1  1/44 (2.27%)  1
Fatigue  1  28/44 (63.64%)  116
Fever  1  20/44 (45.45%)  26
Pain-Chest  1  1/44 (2.27%)  1
Syndromes  1  1/44 (2.27%)  1
Hepatobiliary disorders   
Gallbladder pain  1  1/44 (2.27%)  2
Immune system disorders   
Hypersensitivity  1  3/44 (6.82%)  3
Infections and infestations   
Abdominal infection  1  1/44 (2.27%)  1
Arthritis infective  1  1/44 (2.27%)  1
Blood Infection  1  1/44 (2.27%)  1
Infection without neutropenia  1  2/44 (4.55%)  2
Lymph gland infection  1  1/44 (2.27%)  1
Lymphatic infection  1  1/44 (2.27%)  2
Pneumonia  1  2/44 (4.55%)  2
Respiratory tract infection  1  4/44 (9.09%)  4
Sinus infection  1  1/44 (2.27%)  1
Sinusitis  1  2/44 (4.55%)  2
Skin (cellulites) infection  1  1/44 (2.27%)  1
Upper airway infection  1  2/44 (4.55%)  2
Urinary tract infection  1  1/44 (2.27%)  1
Investigations   
Aspartate aminotransferase increased  1  1/44 (2.27%)  1
Bilirubin  1  1/44 (2.27%)  1
Leukopenia  1  34/44 (77.27%)  227
Neutrophil count decreased  1  38/44 (86.36%)  231
Platelet count decreased  1  32/44 (72.73%)  262
Metabolism and nutrition disorders   
Anorexia  1  4/44 (9.09%)  6
Dehydration  1  1/44 (2.27%)  3
Hyponatremia  1  2/44 (4.55%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/44 (2.27%)  1
Bone pain  1  1/44 (2.27%)  1
Myalgia  1  4/44 (9.09%)  4
Nervous system disorders   
Headache  1  1/44 (2.27%)  1
Peripheral sensory neuropathy  1  1/44 (2.27%)  1
Psychiatric disorders   
Insomnia  1  1/44 (2.27%)  1
Renal and urinary disorders   
Urinary frequency  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/44 (2.27%)  1
Dyspnea  1  4/44 (9.09%)  9
Hypoxia  1  1/44 (2.27%)  1
Pneumonitis  1  1/44 (2.27%)  1
Pulmonary hypertension  1  1/44 (2.27%)  1
Skin and subcutaneous tissue disorders   
Photosensitivity  1  1/44 (2.27%)  1
Pruritus  1  2/44 (4.55%)  3
Rash  1  25/44 (56.82%)  48
Sweating  1  2/44 (4.55%)  2
Vascular disorders   
Flushing  1  1/44 (2.27%)  1
Hot flashes  1  1/44 (2.27%)  1
Hypertension  1  2/44 (4.55%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tait Shanafelt
Organization: Mayo Clinic
EMail: shanafelt.tait@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00602836     History of Changes
Other Study ID Numbers: CDR0000582676
P30CA015083 ( U.S. NIH Grant/Contract )
MC0784 ( Other Identifier: Mayo Clinic Cancer Center )
07-002156 ( Other Identifier: Mayo Clinic IRB )
RV-CLL-PI-146 ( Other Identifier: Celgene Protocol )
NCI-2009-01281 ( Registry Identifier: NCI CTRP )
First Submitted: January 12, 2008
First Posted: January 28, 2008
Results First Submitted: March 15, 2012
Results First Posted: April 11, 2012
Last Update Posted: October 13, 2017