Trial Outcomes & Findings for Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma (NCT NCT00445341)
NCT ID: NCT00445341
Last Updated: 2018-01-30
Results Overview
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
47 months
Results posted on
2018-01-30
Participant Flow
Participant milestones
| Measure |
Flavopiridol in Lymphoma Patients
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 Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Flavopiridol in Lymphoma Patients
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 Study
refused further treatment
|
1
|
|
Overall Study
taken off treatment too early
|
1
|
Baseline Characteristics
Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Flavopiridol in Lymphoma Patients
n=28 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
58.71 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 47 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Flavopiridol in Lymphoma Patients
n=28 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (e.g. Toxicity)
|
28 Participants
|
PRIMARY outcome
Timeframe: 2/16/2007 - 1/20/2011Response 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.
Outcome measures
| Measure |
Flavopiridol in Lymphoma Patients
n=26 Participants
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.
|
|---|---|
|
Response Rate (Complete Response (CR) and Partial Response (PR))
Complete Response
|
0 Participants
|
|
Response Rate (Complete Response (CR) and Partial Response (PR))
Partial Response
|
2 Participants
|
Adverse Events
Flavopiridol in Lymphoma Patients
Serious events: 14 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flavopiridol in Lymphoma Patients
n=28 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block::AV Block-Third degree (Complete AV block)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Nervous system disorders
Confusion
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Metabolism and nutrition disorders
Creatinine
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Cardiac disorders
Hypotension
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
2/28 • Number of events 3 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Reproductive system and breast disorders
Pain::Abdomen NOS
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Platelets
|
7.1%
2/28 • Number of events 3 • 47 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Renal and urinary disorders
Renal failure
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Nervous system disorders
Syncope (fainting)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
7.1%
2/28 • Number of events 2 • 47 months
|
Other adverse events
| Measure |
Flavopiridol in Lymphoma Patients
n=28 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
46.4%
13/28 • Number of events 47 • 47 months
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
78.6%
22/28 • Number of events 84 • 47 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
82.1%
23/28 • Number of events 136 • 47 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
57.1%
16/28 • Number of events 33 • 47 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Anorexia
|
28.6%
8/28 • Number of events 8 • 47 months
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
32.1%
9/28 • Number of events 13 • 47 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
42.9%
12/28 • Number of events 31 • 47 months
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
14.3%
4/28 • Number of events 6 • 47 months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
14.3%
4/28 • Number of events 15 • 47 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
32.1%
9/28 • Number of events 23 • 47 months
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Nervous system disorders
Confusion
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Constipation
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Metabolism and nutrition disorders
Creatinine
|
32.1%
9/28 • Number of events 15 • 47 months
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Dehydration
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Gastrointestinal disorders
Diarrhea
|
78.6%
22/28 • Number of events 99 • 47 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
21.4%
6/28 • Number of events 6 • 47 months
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
32.1%
9/28 • Number of events 11 • 47 months
|
|
Infections and infestations
Febrile neutropenia
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.0%
7/28 • Number of events 9 • 47 months
|
|
Metabolism and nutrition disorders
Glomerular filtration rate
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
21.4%
6/28 • Number of events 12 • 47 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
78.6%
22/28 • Number of events 145 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Cardiac disorders
Hypotension
|
25.0%
7/28 • Number of events 9 • 47 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
General disorders
Insomnia
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
85.7%
24/28 • Number of events 148 • 47 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
92.9%
26/28 • Number of events 156 • 47 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
42.9%
12/28 • Number of events 30 • 47 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
57.1%
16/28 • Number of events 61 • 47 months
|
|
Nervous system disorders
Mood alteration::Depression
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, calf cramping)
|
3.6%
1/28 • Number of events 2 • 47 months
|
|
Gastrointestinal disorders
Nausea
|
89.3%
25/28 • Number of events 48 • 47 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
78.6%
22/28 • Number of events 108 • 47 months
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
21.4%
6/28 • Number of events 8 • 47 months
|
|
Reproductive system and breast disorders
Pain::Abdomen NOS
|
10.7%
3/28 • Number of events 3 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
14.3%
4/28 • Number of events 4 • 47 months
|
|
Nervous system disorders
Pain::Head/headache
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
67.9%
19/28 • Number of events 79 • 47 months
|
|
Blood and lymphatic system disorders
Platelets
|
75.0%
21/28 • Number of events 112 • 47 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
25.0%
7/28 • Number of events 15 • 47 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
28.6%
8/28 • Number of events 25 • 47 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
General disorders
Rigors/chills
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
28.6%
8/28 • Number of events 25 • 47 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
57.1%
16/28 • Number of events 37 • 47 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.6%
1/28 • Number of events 2 • 47 months
|
|
Nervous system disorders
Syncope (fainting)
|
10.7%
3/28 • Number of events 4 • 47 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
17.9%
5/28 • Number of events 13 • 47 months
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
7.1%
2/28 • Number of events 2 • 47 months
|
|
Eye disorders
Vision-blurred vision
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
16/28 • Number of events 40 • 47 months
|
|
General disorders
Weight gain
|
3.6%
1/28 • Number of events 1 • 47 months
|
|
General disorders
Weight loss
|
3.6%
1/28 • Number of events 1 • 47 months
|
Additional Information
Kieron Dunleavy, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-1007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place