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Alkylating agents
Rituximab + Chemotherapy for Hairy Cell Leukemia
Phase 2
Waitlist Available
Led By Robert J Kreitman, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of HCL by flow cytometry of blood or a solid (lymph node) mass, confirmed by the Laboratory of Pathology, NCI, including positivity for CD19, CD22, CD20, and CD11c
BMBx or BMA consistent with HCL, confirmed by NIH Laboratory of Pathology, NCI, or the Department of Laboratory Medicine, Clinical Center, NIH, unless the diagnosis can be confirmed from a solid (lymph node) mass
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing whether two different drugs, pentostatin and bendamustine, are more effective when combined with rituximab to treat hairy cell leukemia than rituximab alone.
Who is the study for?
Adults diagnosed with hairy cell leukemia that hasn't improved or has returned after standard treatments. They must have specific blood conditions, organ function within certain limits, and agree to birth control if applicable. Excluded are those with active infections, severe heart disease, HIV/hepatitis B/C, pregnant/nursing women, non-responsive to both drug combinations previously or unable to follow the trial procedures.Check my eligibility
What is being tested?
The trial is testing whether rituximab combined with either pentostatin or bendamustine is more effective for treating hairy cell leukemia than rituximab alone. Participants will undergo four treatment cycles of 28 days each and receive these drugs on specified days while their health is closely monitored through tests and biopsies.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response such as fever and chills (infusion reactions), low blood counts leading to increased infection risk or bleeding problems, liver enzyme changes indicating potential liver issues, fatigue from anemia or other causes related to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood or lymph node test shows I have hairy cell leukemia.
Select...
My hairy cell leukemia diagnosis is confirmed by a specific biopsy or blood test.
Select...
My blood test shows I might have a variant form of hairy cell leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR(PR+CR))
Secondary outcome measures
HCL biology
correlation of MRD levels and tumor markers with response
mechanism of thrombocytopenia
+2 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3Experimental Treatment2 Interventions
Rituximab + Bendamustine (at the tolerated dose)
Group II: Arm 2Experimental Treatment2 Interventions
Rituximab +bendamustine at 90 mg/m2 for initial tolerability study (closed)
Group III: Arm 1Experimental Treatment2 Interventions
Rituximab + bendamustine at 70 mg/m2 for initial tolerability study (closed)
Group IV: Arm 4Active Control2 Interventions
Rituximab + Pentostatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~2950
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,599 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need treatment for symptoms like frequent infections, low blood counts, or enlarged spleen.My blood or lymph node test shows I have hairy cell leukemia.I have an active infection that hasn't been treated.I do not have severe heart disease.I have been diagnosed with HIV, hepatitis B, or hepatitis C.I have a condition affecting my brain or spinal cord.I do not need treatment for any other cancer besides the one being studied.My hairy cell leukemia diagnosis is confirmed by a specific biopsy or blood test.I did not respond to treatments with pentostatin plus rituximab and bendamustine plus rituximab.I have not received a live vaccine in the last 4 weeks.My blood test shows I might have a variant form of hairy cell leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 3
- Group 3: Arm 4
- Group 4: Arm 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Rituximab been given the green light by the Food and Drug Administration?
"Based on the available clinical evidence, our team at Power has assigned Rituximab a score of 2. This is due to Phase 2 data indicating that while there are some safety findings, no efficacy results have been established yet."
Answered by AI
How many individuals have enrolled in this medical research?
"Affirmative. Clinicaltrials.gov conveys that this medical trial is actively recruiting; it was initially posted on July 1st 2010 and recently amended on October 19th 2022. Two clinical sites are looking for a total of 200 participants to join the experiment."
Answered by AI
Are there any available slots to participate in this trial at the present time?
"Affirmative. According to records found on clinicaltrials.gov, this medical trial first opened its doors for recruitment in July of 2010 and is still actively seeking participants as of October 19th 2022. Two sites are needed to accommodate the 200 patients being sought after by the study's investigators."
Answered by AI
What illnesses has Rituximab been demonstrated to ameliorate?
"Rituximab is the most commonly used treatment for b-cell lymphomas. It has also been employed to treat polyangium, multiple myeloma and rheumatoid arthritis effectively."
Answered by AI
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