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Immunotoxin
Moxetumomab + Rituximab/Ruxience for Hairy Cell Leukemia
Phase 1
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
Age greater than or equal to 18 years as the disease under study, HCL/HCLv, has not been reported in children < age 18.
ECOG performance status less than or equal to2 (Karnofsky greater than or equal to 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group.
Awards & highlights
Study Summary
This trial is testing the safety of combining two drugs, Rituximab/Ruxience and Moxetumomab pasudotox, to treat hairy cell leukemia or a variant of it. Eligible participants must be 18 or older and the cancer must not have responded to standard therapy.
Who is the study for?
Adults over 18 with Hairy Cell Leukemia (HCL) or its variant, who haven't responded to standard therapy. They must have certain blood count levels, be Pseudomonas-immunotoxin naive, and have adequate organ function. Participants should not be pregnant or breastfeeding and must use effective contraception. Those with a history of certain medical conditions like heart disease are excluded.Check my eligibility
What is being tested?
The trial is testing the safety of combining Moxetumomab pasudotox-tdfk (Lumoxiti) with Rituximab/Ruxience in patients with relapsed HCL. The treatment involves up to eight cycles of these drugs administered intravenously, along with medications to prevent allergic reactions and instructions for hydration and aspirin intake.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to infusion, increased risk of infections due to immune system suppression by the drugs, possible liver enzyme elevations indicating liver stress or damage, fatigue from anemia caused by bone marrow suppression, and other non-specified drug-related effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with hairy cell leukemia.
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I need treatment for low blood counts or symptoms from an enlarged spleen or HCL mass.
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My kidney function is within the required range.
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I have HCL or HCLv and have been treated with a purine analog. If I have HCL, I've also had another therapy if my first treatment worked for more than 2 years and 1 month.
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My kidney function is normal based on creatinine levels or clearance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Safe Dose of Moxetumomab Pasudotox-tdfk
Recommended Safe Dose of Rituximab/Ruxience
Secondary outcome measures
Duration of Response (DOR)
Number of Participants Who Are Minimal Residual Disease (MRD)-Free
Number of Participants Whose Cancer Shrinks or Disappears After Treatment
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Number of Participants With a Dose-limiting Toxicity (DLT)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Moxetumomab - Dose Expansion 40 mcg/kgExperimental Treatment7 Interventions
Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience
Group II: Moxetumomab - Dose Escalation 30 mcg/kgExperimental Treatment7 Interventions
Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Acetaminophen
2017
Completed Phase 4
~2030
Aspirin
2014
Completed Phase 4
~55580
Diphenhydramine
2002
Completed Phase 4
~1170
Rituximab
1999
Completed Phase 4
~1880
Famotidine
2005
Completed Phase 4
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,887 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have Hepatitis B but am under treatment and my viral load is low.I am a man who can father children and will use birth control during and after the trial.I can take care of myself but might not be able to do heavy physical work.I have a history of blood clots and a genetic condition that makes my blood clot more easily.I have been diagnosed with hairy cell leukemia.I need treatment for low blood counts or symptoms from an enlarged spleen or HCL mass.I am a man who can father children and will use birth control during and after the trial.I am using or willing to use effective birth control if I'm a woman under 50 and sexually active with a man.I am using or willing to use effective birth control for the study and 12 months after.I need treatment for low blood counts or symptoms related to my spleen or HCL mass.I am over 18 and have HCL or HCLv, treated with at least one purine analog and, if applicable, another therapy.My kidney function is within the required range.I have had a bone marrow transplant from another person.I have a history of blood clotting disorders.I am not pregnant or breastfeeding during the study.I do not have brain metastases.I do not have any serious ongoing illnesses that would stop me from following the study's requirements.I haven't had chemotherapy, immunotherapy, radiotherapy in the last 4 weeks, or rituximab/Ruxience in the last 3 months.I have a detached retina or choroid.I do not have an active cancer needing treatment, except for minor skin cancers.I am HIV-positive but on effective treatment with a CD4 count over 200.I have not had radioimmunotherapy in the last 2 years.I am taking more than 0.625 mg/day of estrogen.I have HCL or HCLv and have been treated with a purine analog. If I have HCL, I've also had another therapy if my first treatment worked for more than 2 years and 1 month.My organs and bone marrow are working well.My kidney function is normal based on creatinine levels or clearance.I will use effective birth control while on moxetumomab pasudotox-tdfk and rituximab/Ruxience.I do not have severe blood clotting issues.My lung function tests show less than half the normal capacity.
Research Study Groups:
This trial has the following groups:- Group 1: Moxetumomab - Dose Escalation 30 mcg/kg
- Group 2: Moxetumomab - Dose Expansion 40 mcg/kg
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.
What therapeutic purposes does Moxetumomab Pasudotox-tdfk typically serve?
"Diffuse large b-cell lymphoma (dlbcl) and other B-Cell Lymphomas may be treated with Moxetumomab Pasudotox-tdfk if the patient has previously undergone two systemic chemotherapy regimens."
Answered by AI
Is the enrollment for this experiment ongoing?
"Correct. Clinicaltrials.gov documents that this clinical trial, which first went public on October 3rd 2019, is actively searching for participants to enroll. A total of 30 patients are needed from a single medical centre."
Answered by AI
What risks do patients face when utilizing Moxetumomab Pasudotox-tdfk?
"Due to the limited clinical data surrounding moxetumomab pasudotox-tdfk, this medication earned a safety score of 1 on Power's scale."
Answered by AI
How many participants are taking part in this research project?
"Yes, the evidence held on clinicaltrials.gov reveals that enrollment is presently underway for this trial which was posted in October 2019 and refreshed last month. A total of 30 participants are needed from one medical site."
Answered by AI
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