Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00445341
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : October 5, 2012
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Roschewski, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Drug: Flavopiridol
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flavopiridol in Lymphoma Patients
Hide Arm/Group Description Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
Period Title: Overall Study
Started 28
Completed 26
Not Completed 2
Reason Not Completed
refused further treatment             1
taken off treatment too early             1
Arm/Group Title Flavopiridol in Lymphoma Patients
Hide Arm/Group Description Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  67.9%
>=65 years
9
  32.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
58.71  (13.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
8
  28.6%
Male
20
  71.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
2
   7.1%
Not Hispanic or Latino
26
  92.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.6%
White
26
  92.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (e.g. Toxicity)
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time Frame 47 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flavopiridol in Lymphoma Patients
Hide Arm/Group Description:
Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
28
 100.0%
2.Primary Outcome
Title Response Rate (Complete Response (CR) and Partial Response (PR))
Hide Description Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (</= 1.5 cm in greatest diameter if > 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to </= 1 cm or by more than 75% in the sum of the products of the greatest diameters (SPD). Spleen, if considered to be enlarged before therapy, must have regressed in size. Partial response is a >/= 50% decrease in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >/= 50% in the SPD. Bone marrow is irrelevant for determination of a PR.
Time Frame 2/16/2007 - 1/20/2011
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flavopiridol in Lymphoma Patients
Hide Arm/Group Description:
Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
2
   7.7%
Time Frame 47 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flavopiridol in Lymphoma Patients
Hide Arm/Group Description Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
All-Cause Mortality
Flavopiridol in Lymphoma Patients
Affected / at Risk (%)
Total   0/28 (0.00%)    
Hide Serious Adverse Events
Flavopiridol in Lymphoma Patients
Affected / at Risk (%) # Events
Total   14/28 (50.00%)    
Blood and lymphatic system disorders   
Edema: head and neck  1  1/28 (3.57%)  1
Edema: limb  1  1/28 (3.57%)  1
Hemoglobin  1  1/28 (3.57%)  1
Leukocytes (total WBC)  1  3/28 (10.71%)  3
Lymphopenia  1  2/28 (7.14%)  3
Platelets  1  2/28 (7.14%)  3
Cardiac disorders   
Cardiac troponin I (cTnI)  1  1/28 (3.57%)  1
Conduction abnormality/atrioventricular heart block::AV Block-Third degree (Complete AV block)  1  1/28 (3.57%)  1
Hypotension  1  2/28 (7.14%)  2
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  2/28 (7.14%)  2
Gastrointestinal disorders   
Diarrhea  1  1/28 (3.57%)  1
Heartburn/dyspepsia  1  1/28 (3.57%)  1
Hemorrhage, GI::Rectum  1  2/28 (7.14%)  2
General disorders   
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/28 (3.57%)  1
Infections and infestations   
Infection  1 [1]  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood  1  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)  1  1/28 (3.57%)  1
Metabolism and nutrition disorders   
Creatinine  1  3/28 (10.71%)  3
Potassium, serum-high (hyperkalemia)  1  1/28 (3.57%)  1
Tumor lysis syndrome  1  3/28 (10.71%)  3
Uric acid, serum-high (hyperuricemia)  1  1/28 (3.57%)  1
Albumin, serum-low (hypoalbuminemia)  1  2/28 (7.14%)  2
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized  1  1/28 (3.57%)  1
Pain::Neck  1  1/28 (3.57%)  1
Nervous system disorders   
Confusion  1  1/28 (3.57%)  1
Dizziness  1  1/28 (3.57%)  1
Somnolence/depressed level of consciousness  1  1/28 (3.57%)  1
Syncope (fainting)  1  1/28 (3.57%)  1
Renal and urinary disorders   
Renal failure  1  1/28 (3.57%)  1
Reproductive system and breast disorders   
Pain::Abdomen NOS  1  1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/28 (3.57%)  1
Hypoxia  1  1/28 (3.57%)  1
Vascular disorders   
Thrombosis/thrombus/embolism  1  1/28 (3.57%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L::Colon
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flavopiridol in Lymphoma Patients
Affected / at Risk (%) # Events
Total   28/28 (100.00%)    
Blood and lymphatic system disorders   
Edema: limb  1  6/28 (21.43%)  6
Edema: trunk/genital  1  1/28 (3.57%)  1
Hemoglobin  1  22/28 (78.57%)  145
Leukocytes (total WBC)  1  24/28 (85.71%)  148
Lymphopenia  1  26/28 (92.86%)  156
Neutrophils/granulocytes (ANC/AGC)  1  22/28 (78.57%)  108
PTT (Partial Thromboplastin Time)  1  6/28 (21.43%)  8
Platelets  1  21/28 (75.00%)  112
Cardiac disorders   
Hypotension  1  7/28 (25.00%)  9
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  2/28 (7.14%)  2
Eye disorders   
Vision-blurred vision  1  1/28 (3.57%)  1
Gastrointestinal disorders   
Anorexia  1  8/28 (28.57%)  8
Constipation  1  3/28 (10.71%)  3
Dehydration  1  2/28 (7.14%)  2
Diarrhea  1  22/28 (78.57%)  99
Distension/bloating, abdominal  1  1/28 (3.57%)  1
Dysphagia (difficulty swallowing)  1  2/28 (7.14%)  2
Mucositis/stomatitis (clinical exam)::Oral cavity  1  2/28 (7.14%)  2
Mucositis/stomatitis (functional/symptomatic)::Oral cavity  1  2/28 (7.14%)  2
Nausea  1  25/28 (89.29%)  48
Taste alteration (dysgeusia)  1  1/28 (3.57%)  1
Vomiting  1  16/28 (57.14%)  40
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  9/28 (32.14%)  11
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  7/28 (25.00%)  9
Insomnia  1  1/28 (3.57%)  1
Rigors/chills  1  2/28 (7.14%)  2
Weight gain  1  1/28 (3.57%)  1
Weight loss  1  1/28 (3.57%)  1
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/28 (3.57%)  1
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  1/28 (3.57%)  1
Cytokine release syndrome/acute infusion reaction  1  1/28 (3.57%)  1
Infections and infestations   
Febrile neutropenia  1 [1]  1/28 (3.57%)  1
Infection  1 [2]  1/28 (3.57%)  1
Infection  1 [3]  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)  1  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood  1  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon  1  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx  1  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum  1  1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS  1  1/28 (3.57%)  1
Metabolism and nutrition disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  13/28 (46.43%)  47
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  22/28 (78.57%)  84
Albumin, serum-low (hypoalbuminemia)  1  23/28 (82.14%)  136
Alkaline phosphatase  1  16/28 (57.14%)  33
Bicarbonate, serum-low  1  9/28 (32.14%)  13
Bilirubin (hyperbilirubinemia)  1  12/28 (42.86%)  31
CPK (creatine phosphokinase)  1  4/28 (14.29%)  6
Calcium, serum-high (hypercalcemia)  1  4/28 (14.29%)  15
Calcium, serum-low (hypocalcemia)  1  9/28 (32.14%)  23
Cholesterol, serum-high (hypercholesteremia)  1  1/28 (3.57%)  1
Creatinine  1  9/28 (32.14%)  15
Glomerular filtration rate  1  1/28 (3.57%)  1
Glucose, serum-high (hyperglycemia)  1  6/28 (21.43%)  12
Glucose, serum-low (hypoglycemia)  1  1/28 (3.57%)  1
Magnesium, serum-high (hypermagnesemia)  1  12/28 (42.86%)  30
Magnesium, serum-low (hypomagnesemia)  1  16/28 (57.14%)  61
Phosphate, serum-low (hypophosphatemia)  1  19/28 (67.86%)  79
Potassium, serum-high (hyperkalemia)  1  7/28 (25.00%)  15
Potassium, serum-low (hypokalemia)  1  8/28 (28.57%)  25
Sodium, serum-high (hypernatremia)  1  8/28 (28.57%)  25
Sodium, serum-low (hyponatremia)  1  16/28 (57.14%)  37
Uric acid, serum-high (hyperuricemia)  1  5/28 (17.86%)  13
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower  1  1/28 (3.57%)  1
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized  1  2/28 (7.14%)  2
Musculoskeletal/Soft Tissue - Other (Specify, calf cramping)  1  1/28 (3.57%)  2
Pain::Back  1  2/28 (7.14%)  2
Pain::Bone  1  4/28 (14.29%)  4
Pain::Muscle  1  2/28 (7.14%)  2
Nervous system disorders   
Confusion  1  1/28 (3.57%)  1
Dizziness  1  3/28 (10.71%)  3
Mood alteration::Depression  1  1/28 (3.57%)  1
Pain::Head/headache  1  2/28 (7.14%)  2
Syncope (fainting)  1  3/28 (10.71%)  4
Renal and urinary disorders   
Urinary retention (including neurogenic bladder)  1  2/28 (7.14%)  2
Reproductive system and breast disorders   
Pain::Abdomen NOS  1  3/28 (10.71%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/28 (7.14%)  2
Dyspnea (shortness of breath)  1  3/28 (10.71%)  3
Hemorrhage, pulmonary/upper respiratory::Nose  1  1/28 (3.57%)  1
Hiccoughs (hiccups, singultus)  1  1/28 (3.57%)  1
Hypoxia  1  1/28 (3.57%)  1
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body)  1  1/28 (3.57%)  1
Injection site reaction/extravasation changes  1  1/28 (3.57%)  1
Pruritus/itching  1  1/28 (3.57%)  1
Rash/desquamation  1  2/28 (7.14%)  2
Rash: hand-foot skin reaction  1  1/28 (3.57%)  1
Sweating (diaphoresis)  1  1/28 (3.57%)  2
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  1/28 (3.57%)  1
Thrombosis/thrombus/embolism  1  1/28 (3.57%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >= 38.5 degrees C)
[2]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood
[3]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Urinary tract NOS
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
Layout table for Results Point of Contact information
Name/Title: Kieron Dunleavy, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-435-1007
EMail: DunleavK@mail.nih.gov
Layout table for additonal information
Responsible Party: Mark Roschewski, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00445341    
Other Study ID Numbers: 070081
07-C-0081
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: September 5, 2012
Results First Posted: October 5, 2012
Last Update Posted: January 30, 2018