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NCT01361711 · ClinicalTrials.gov registry record · Phase 2
Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
A Phase 2 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 2
- Study locations
NCT01361711: Active Phase 2 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, sponsored by Northwestern University.
NCT01361711 is a Phase 2 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 53 participants, below the 206-participant average among 3 other Stage I Chronic Lymphocytic Leukemia trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01361711, a Phase 2 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving alemtuzumab together with ofatumumab may kill more cancer cells
Primary Outcome
CR= Absence of clonal lymphocytes in the peripheral blood, significant lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms. Blood counts: Neutrophils ≥ 1,500/μL; Platelets \>100,000μL; Hemoglobin \> 11.0g/dL. Bone marrow normocellular for age, less than 30% of nucleated cells = lymphocytes. Lymphoid nodules absent. CRi= Fulfills CR but anemia or thrombocytopenia or neutropenia related to drug toxicity. PR= 2 criteria from group A and 1 from Group B. Group A: Decrease in th
Conditions Studied
Interventions
- PROCEDURE biopsy
- BIOLOGICAL alemtuzumab
- BIOLOGICAL ofatumumab
Study Locations (2)
Illinois
- Northwestern University - Chicago
Other
- Karolinska University Hospital Solna - Stockholm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2011-06 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What the registry record for NCT01361711 still lists
NCT01361711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 206-participant average among 3 other Stage I Chronic Lymphocytic Leukemia trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Stage I Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which biopsy is the first listed.
NCT01361711 reports a single indexed study location in Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT01361711 about?
NCT01361711 is a clinical study titled "Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia". This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in different ways. Some blo...
What is the current status of trial NCT01361711?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2011-06. Estimated completion is 2027-05.
What conditions does trial NCT01361711 study?
This clinical trial studies the following conditions: Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT01361711?
The interventions under investigation include: biopsy (PROCEDURE), alemtuzumab (BIOLOGICAL), ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01361711?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01361711 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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