← Back to Search

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
Must not have
Presence of active untreated infection
Uncontrolled coronary disease or NYHA class III-IV heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active infection that hasn't been treated.
Select...
I do not have severe heart disease.
Select...
I have been diagnosed with HIV, hepatitis B, or hepatitis C.
Select...
I have a condition affecting my brain or spinal cord.
Select...
I did not respond to treatments with pentostatin plus rituximab and bendamustine plus rituximab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR)
Secondary study objectives
Cluster of Differentiation 4 (CD4+) T-cells
Correlation of Measurable Residual Disease (MRD) Levels and Tumor Markers With Response
Disease-free Survival (DFS)
+7 more
Other study objectives
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 with RituximabExperimental Treatment10 Interventions
After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab
Group II: Arm 2 - Non-randomized to 90 mg/m^2 Bendamustine-RituximabExperimental Treatment9 Interventions
Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed)
Group III: Arm 1 - Non-Randomized to 70 mg/m^2 Bendamustine-RituximabExperimental Treatment9 Interventions
Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed)
Group IV: Arm 3 - Randomized to 90 mg/m^2 Bendamustine-RituximabActive Control9 Interventions
Rituximab + Bendamustine (at the tolerated dose)
Group V: Arm 4 - Randomized to Pentostatin-RituximabActive Control9 Interventions
Rituximab + Pentostatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Rituximab
1999
Completed Phase 4
~2990
Diphenhydramine
2002
Completed Phase 4
~1170
Bendamustine
2015
Completed Phase 3
~3230
Pentostatin
2000
Completed Phase 3
~1300
Epinephrine
2014
Completed Phase 4
~3940
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,119 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,314 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01059786 — Phase 2
Hairy Cell Leukemia Research Study Groups: Arm 1 - Non-Randomized to 70 mg/m^2 Bendamustine-Rituximab, Arm 2 - Non-randomized to 90 mg/m^2 Bendamustine-Rituximab, Arm 3 - Randomized to 90 mg/m^2 Bendamustine-Rituximab, Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 with Rituximab, Arm 4 - Randomized to Pentostatin-Rituximab
Hairy Cell Leukemia Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT01059786 — Phase 2
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01059786 — Phase 2
~4 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top