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NCT01500733 · ClinicalTrials.gov registry record · Phase 2
PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study of Leukemia and CLL (Chronic Lymphocytic Leukemia), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Active
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 1
- Study location
NCT01500733: Active Phase 2 study of Leukemia and CLL (Chronic Lymphocytic Leukemia), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01500733 is a Phase 2 study of Leukemia and CLL (Chronic Lymphocytic Leukemia) that is active but no longer recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 86 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01500733, a Phase 2 study of Leukemia and CLL (Chronic Lymphocytic Leukemia), is active but no longer recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood cells that hurt the immune system and make it more difficult to fight infections. These cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL. They may have other health problems that make chemotherapy difficult. In addition, individuals who have a genetic abnormality called 17p deletion also do not respond well to standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug, PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups. Objectives: \- To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and people with 17p deletion. Eligibility: * Individuals over 65 years of age who have CLL/SLL. * Individuals at least 18 years of age who have CLL/SLL and 17p deletion. Design: * Participants will be screened with a medical history, physical exam, and imaging studies. Blood and urine samples will be taken. Optional bone marrow and lymph node biopsies may also be taken. * Participants will take PCI-32765 capsules every day for 28 days (one cycle of treatment). Treatment will be monitored with frequent blood tests and clinic visits. * PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug will continue to take it as long as there are no side effects and the disease does not progress. Those who do not benefit will stop treatment and have regular followup exams.
Primary Outcome
The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows: Complete response (CR): all group A and group B criteria are met * Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count \< 4,000/uL, normocellular bone marrow with \< 30% lymphocytes without nodule
Conditions Studied
Interventions
- DRUG PCI 32765
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2012-01-05 |
| Est. Completion | 2034-09-30 |
| Phase | Phase 2 |
What the registry record for NCT01500733 still lists
NCT01500733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which PCI 32765 is the first listed.
NCT01500733 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01500733 about?
NCT01500733 is a clinical study titled "PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". Background: \- Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood cells that hurt the immune system and make it more difficult to fight infections. These cancers are ...
What is the current status of trial NCT01500733?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2012-01-05. Estimated completion is 2034-09-30.
What conditions does trial NCT01500733 study?
This clinical trial studies the following conditions: Leukemia, CLL (Chronic Lymphocytic Leukemia), SLL (Small Lymphocytic Lymphoma), Leukemia, Lymphocytyc.
What interventions are being tested in trial NCT01500733?
The interventions under investigation include: PCI 32765 (DRUG).
Who is sponsoring clinical trial NCT01500733?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01500733 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01500733's enrollment target sits among peer trials
86 75th of 233 higher than 159 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
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