A Phase 1 interventional study of cefepime hydrochloride in Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia and Adult Burkitt Lymphoma, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment
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Among 19 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Wake Forest University Health Sciences — 3 open to participants now, 3 under way, none of them phase 3. Precursor Cell Lymphoblastic Leukemia-Lymphoma · Wake Forest University Health Sciences.
Among the 19 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Wake Forest University Health Sciences, this one is the 3rd largest by enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2011, is one of 6 in phase 1, and was the 11th registered.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →3 of the 19 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Wake Forest University Health Sciences are open now, in 1 country. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Ages 18+
Wake Forest University Health Sciences · Sites in United States
Ages 18–120
Wake Forest University Health Sciences · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 370 Precursor Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 96 (26%) set no upper age limit and 257 (69%) stop at 75 or younger; 247 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 2 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 70 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Median enrollment 40 across the 16 interventional studies, 2,000 across the 3 observational. Of the 15 that completed or were terminated, 4 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
1 of the studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Wake Forest University Health Sciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01890486Wake Forest University Health SciencesThe Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen | 2026-12 |
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Among the 19 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Wake Forest University Health Sciences, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.
OBJECTIVES:
I. The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.
OUTLINE: Patients are randomized 1 of 2 treatment arms.
All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.
ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.
ARM II: Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive cefepime hydrochloride IV over 30 minutes.
Drug: cefepime hydrochloride
Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
Drug: cefepime hydrochloride
Given IV
Also known as: cefepime, Maxipime
Defervescence (without hypothermia)
Comparison between groups will be done using the chi square test. T-tests will be used for continues variables. Survival data will be estimated using the Kaplan-Meier method, with the formal test of group comparisons done using Cox's Proportional Hazards Model.
Time frame: 72 hours
Clinical success or failure
Time frame: approximately 24 days
Need for additional antimicrobials
Time frame: approximately 24 days
Mortality (in-house)
Time frame: approximately 24 days
Time to defervescence
Time frame: approximately 24 days
Hospital length of stay
Time frame: approximately 24 days
Successful treatment of baseline infection
Time frame: approximately 24 days
The record gives a start of Feb 2011, a primary completion of Jun 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cefepime
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Wake Forest University Health Sciences →