Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01059786 · ClinicalTrials.gov registry record · Phase 2
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
A Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT01059786: Active Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
NCT01059786 is a Phase 2 study of Hairy Cell Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 69 participants, roughly in line with the 68-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01059786, a Phase 2 study of Hairy Cell Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that has not responded well to or has recurred after standard HCL therapies. One nonstandard treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the immune system destroy them. By combining rituximab with other anti-cancer drugs, researchers hope to determine whether the combined drugs are successful in treating HCL. * Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat different kinds of blood and immune system cancers. Bendamustine is approved to treat other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin has been used for more than 20 years to treat HCL, but it has not been combined with rituximab in official clinical trials. Objectives: * To determine whether rituximab with either pentostatin or bendamustine is a more effective treatment for HCL than rituximab alone. * To determine whether pentostatin or bendamustine is a more effective treatment for HCL when combined with rituximab. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that has not responded well to or has relapsed after standard HCL therapies. Design: * The study will last for four treatment cycles of 28 days each. * Prior to the study, participants will be screened with a full medical history and physical exam, bone marrow biopsy (if one has not been performed in the last 6 months), computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as required by the researchers. Participants will provide blood and urine samples at this time as well. * Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles. * Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of each cycle and pentostatin
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Rituximab
- DRUG Diphenhydramine
- DRUG Bendamustine
- DRUG Pentostatin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2010-07-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059786
The ClinicalTrials.gov registry entry for NCT01059786 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 68-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Acetaminophen is the first listed.
NCT01059786 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01059786 about?
NCT01059786 is a clinical study titled "Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia". Background: * Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that has not responded well to or has recurred after standard HCL therapies. One nonstandard treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the immune system destro...
What is the current status of trial NCT01059786?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2010-07-01. Estimated completion is 2027-12-31.
What conditions does trial NCT01059786 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia.
What interventions are being tested in trial NCT01059786?
The interventions under investigation include: Acetaminophen (DRUG), Rituximab (DRUG), Diphenhydramine (DRUG), Bendamustine (DRUG), Pentostatin (DRUG).
Who is sponsoring clinical trial NCT01059786?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01059786 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
Similar trials for Hairy Cell Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
RECRUITING · Phase 2
-
Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
RECRUITING · Phase 2
-
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
RECRUITING · Phase 2
-
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
RECRUITING · Phase 2
-
Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia
ACTIVE NOT RECRUITING · Phase 2
-
A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
ACTIVE NOT RECRUITING · Phase 2
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.