Chronic Lymphocytic LeukemiaPhase 4NCT00131313
Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
A Phase 4 study testing Nipent, Cytoxan, Rituxan in people with Chronic Lymphocytic Leukemia, run by East Valley Hematology and Oncology Medical Group at 52 sites in United States.
Trial summary
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Nipent, Cytoxan, Rituxan
- How many people
- 180 participants
- Where
- 52 sitesUnited States
- Study dates
- Jan 2003to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II, III or IV Chronic Lymphocytic Leukemia
- Disease requires chemotherapeutic treatment
- CT or MRI scan confirming measurable tumor size
- Documentation of CD markers
- Up to one prior treatment regimen
- Expected survival greater than 6 months
Show all 13Show fewer
- ECOG performance status of 0-2
- Adequate renal, bone marrow and liver functions
- Negative pregnancy test (females of childbearing potential)
- Must agree to use acceptable birth control, if fertile
- Must complete Informed Consent
- No heart disease and must have adequate cardiac function
- Must test negative for viral Hepatitis B and C
Who cannot join
- More than one prior treatment for Chronic Lymphocytic Leukemia
- Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
- Known HIV or AIDS illness
- Thyroid disease requiring medication
- History of any malignancy that could affect the diagnosis or assessment of the study treatment
- Pregnancy or breast feeding
- Evidence of Hepatitis B or C infection
- Inability to comply with the requirements of the study
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites, 52 recruiting
- Recruiting
Cancer Outreach Associates, PC
Abingdon, Virginia, 24211
Forrest Swan, MD
Forest Swan, MD
- Recruiting
Summa Health System Hospitals
Akron, Ohio, 44304
R. Douglas Trochelman, MD
R. Douglas Trochelman, MD
- Recruiting
Augusta Oncology Associates, PC
Augusta, Georgia, 30901
Mark R Keaton, MD
Mark R Keaton, MD
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Madhu Chaudhry, MD, MBBS
Madhu Chaudry, MD, MBBS
- Recruiting
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, 21225
Yudhishtra Markan, MD
Yudhishtra Markan, MD
- Recruiting
Auerbach Hematology Oncology Associates, Inc.
Baltimore, Maryland, 21237
Michael Auerbach, MD, PharmD,FACP
Michael Auerbach, MD, PharmD,FACP
- Recruiting
Mid Dakota Clinic/Odyssey Research
Bismarck, North Dakota, 58501
Bipinkumar R Amin, MD
Bipinkumar R Amin, MD
- Recruiting
St Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Theodore Walters, MD
Theodore Walters, MD
- Recruiting
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435
Eyal Meiri, MD
Eyal Meiri, MD
- Recruiting
Branson Oncology Clinic
Branson, Missouri, 65616
Pairote Jaroonwanichkul, MD
Pairote Jaroonwanichkul, MD
- Recruiting
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505
Raul R Mena, MD
Raul R Mena, MD
- Recruiting
Nashat Y. Gabrail, MD, Inc.
Canton, Ohio, 44718
Nashat Y Gabrail, MD
Nashat Y Gabrail, MD
- Recruiting
Sierra Nevada Oncology Care
Carson City, Nevada, 89703
Jorge Perez-Cardona, MD
Jorge Perez-Cardona, MD
- Recruiting
Charleston Hematology Oncology, PA
Charleston, South Carolina, 29403
George F Geils, Jr., MD
George F Geils, Jr., MD
- Recruiting
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
Stephen Zrada, MD
Stephen Zrada, MD
- Recruiting
The Family Cancer Center
Collierville, Tennessee, 38017
David Gravenor, MD
David Gravenor, MD
- Recruiting
The Oncology Clinic, PC
Colorado Springs, Colorado, 80907
David Headley, DO
David Headley, DO
- Recruiting
South Carolina Oncology Associates
Columbia, South Carolina, 29210
Neal P Christiansen, MD
Neal P Christiansen, MD
- Recruiting
Bay Area Cancer Research Group
Concord, California, 94520
Robert L Robles, MD
Robert L Robles, MD
- Recruiting
Sambandam and Joseph Associates, Inc
Cranston, Rhode Island, 02920
Plakyil J Joseph, MD
Plakyil J Joseph, MD
- Recruiting
Mile High Oncology
Denver, Colorado, 80210
David Schrier, MD, DO
David Schrier, MD, DO
- Recruiting
Ellioth Fishkin, MD
Elizabeth, New Jersey, 07201
Ellioth Fishkin, MD
Ellioth Fishkin, MD
- Recruiting
Genesee Cancer & Blood Disease Treatment Center, PC
Flint, Michigan, 48503
Rizwan Danish, MD, FACP
Rizwan Danish, MD, FACP
- Recruiting
JPS Center for Cancer Care
Fort Worth, Texas, 76104
Debra M Prow, MD
Debra M Prow, MD
- Recruiting
Lalita Pandit, MD, Inc.
Fountain Valley, California, 92708
Lalita Pandit, MD
Lalita Pandit, MD
- Recruiting
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708
Glen R Justice, MD
Glen R Justice, MD
- Recruiting
Robert A. Moss, M.D. FACP, Inc.
Fountain Valley, California, 92708
Robert A Moss, MD, FACP
Robert A Moss, MD, FACP
- Recruiting
West Michigan Regional Cancer & Blood Center
Free Soil, Michigan, 49411
Ahmed S Behairy, MD
Ahmed S Behairy, MD
- Recruiting
C. Michael Jones, MD, PC
Germantown, Tennessee, 38138
C. Michael Jones, MD, PC
C. Michael Jones, MD, PC
- Recruiting
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Timothy O'Rourke, MD
Timothy O'Rourke, MD
- Recruiting
Spalding Oncology Services
Griffin, Georgia, 30224
Rao Moravineni, MD
Rao Moravineni, MD
- Recruiting
Oncology Hematology Assoc. of Northern Illinois
Gurnee, Illinois, 60031
Nilesh D Mehta, MD, FACP
Nilesh D Mehta, MD, FACP
- Recruiting
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
Hassan Ghazal, MD
Hassan Ghazal, MD
- Recruiting
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, 46202
Maureen Cooper, MD
Maureen Cooper, MD
- Recruiting
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Medhi M Moezi, MD
Medhi M Moezi, MD
- Recruiting
Osceola Cancer Center
Kissimmee, Florida, 34741
Jorge G Otoya, MD
Jorge G Otoya, MD
- Recruiting
Arnett Cancer Care
Lafayette, Indiana, 47904
Thomas I Jones, MD
Thomas I Jones, MD
- Recruiting
Nevada Cancer Center
Las Vegas, Nevada, 89109
M. Nafees Nagy, MD
M. Nafees Nagy, MD
- Recruiting
Cache Valley Cancer Treatment & Research Clinic, Inc.
Logan, Utah, 84341
Ali Ben-Jacob, MD
Ali Ben-Jacob, MD
- Recruiting
Metropolitan Hematology Oncology Medical Group
Los Angeles, California, 90057
Peter S Kennedy, MD
Peter S Kennedy, MD
- Recruiting
Westchester Hematology Oncology Associates
Mount Kisco, New York, 10549
Gino Bottino, MD
Gino Bottino, MD
- Recruiting
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, 35661
James Daugherty, MD
James Daugherty, MD
- Recruiting
Cancer Care Center
New Albany, Indiana, 47150
Naveed Chowhan, MD
Naveed Chowhan, MD
- Recruiting
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, 34642
K.S. Kumar, MD
K.S. Kumar, MD
- Recruiting
Pasco Pinellas Cancer Center
New Port Richey, Florida, 34652
Roberto Arevalo-Araujo, MD,PharmD,PA
Roberto Arevalo-Araujo, MD,PharmD,PA
- Recruiting
North County Oncology
Oceanside, California, 92056
Warren S Paroly, MD
Warren S Paroly, MD
- Recruiting
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
Rosemary E McIntyre, MD,PharmD
Rosemary E McIntyre, MD,PharmD
- Recruiting
Cancer and Blood Institute Medical Group
Rancho Mirage, California, 92270
Robert H Lemon, MD
Robert H Lemon, MD
- Recruiting
Virginia Oncology Care, PC
Richlands, Virginia, 24641
Madhaven V Pillai, MD, PharmD,FACP
Madhaven V Pillai, MD, PharmD, FACP
- Recruiting
St. Louis Hematology Oncology Specialists, Inc.
St Louis, Missouri, 63117
Alvin Schergen, MD, PharmD,FACP
Alvin Schergen, MD, PharmD,FACP
- Recruiting
St. Teresa Comprehensive Cancer Center
Stockton, California, 95207
Neelesh S Bangalore, MD, PhD
Neelesh S Bangalore, MD, PhD
- Recruiting
Medical Group of North County
Vista, California, 92081
Alberto Bessudo, MD
Alberto Bessudo, MD
About this study
Official title: A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
Read the detailed description
Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels.
The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Nipent, Cytoxan, Rituxan
- Keywords
- Leukemia, Cancer, Nipent, Rituxan, Cytoxan
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipent, Cytoxan, RituxanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy response rate
Secondary outcomes (4)
Time to progression
Time to treatment failure
Toxicity
Incidence and severity of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startJan 2003
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- East Valley Hematology and Oncology Medical Group
- Sponsor type
- University, hospital or other
- Collaborators
- Mena, Raul, M.D., Pharmatech Oncology, Astex Pharmaceuticals, Inc.
- Investigators
- Raul Mena, MD, Principal investigator, East Valley Hematology and Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131313
- Sponsor's protocol ID
- POI-02818
- Other IDs
- NIP-02-005
- Status last verified
- Aug 2005
- First submitted
- 16 Aug 2005
- Last updated
- 18 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
- ClinicalTrials.gov ID
- NCT00131313
- Acronym / sponsor ID
- POI-02818
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Leukemia, Cancer, Nipent, Rituxan, Cytoxan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants
- Lead sponsor
- East Valley Hematology and Oncology Medical GroupUniversity, hospital or other
- Collaborators
- Mena, Raul, M.D., Pharmatech Oncology, Astex Pharmaceuticals, Inc.
- Study start
- Jan 2003
- Study completion
- Apr 2009
- First posted
- 18 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
Detailed description
Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels.
The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Stage II, III or IV Chronic Lymphocytic Leukemia
- Disease requires chemotherapeutic treatment
- CT or MRI scan confirming measurable tumor size
- Documentation of CD markers
- Up to one prior treatment regimen
Key exclusion criteria (8 listed)
- More than one prior treatment for Chronic Lymphocytic Leukemia
- Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
- Known HIV or AIDS illness
- Thyroid disease requiring medication
- History of any malignancy that could affect the diagnosis or assessment of the study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nipent, Cytoxan, Rituxan | Drug | – |
Primary outcome
Efficacy response rate
4 secondary outcomes
Time to progression
Time to treatment failure
Toxicity
Incidence and severity of adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2005.
- Pharmatech - The Research Link websiteLink provided by the sponsor.
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Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
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RecruitingObservational study
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A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Mena, MD principal investigator
East Valley Hematology and Oncology Group
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nipent, Cytoxan, Rituxan in people with Chronic Lymphocytic Leukemia, run by East Valley Hematology and Oncology Medical Group at 52 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracy Latimer (720-917-7478, tracyl@pharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2005.