Chronic Lymphocytic LeukemiaPhase 2NCT00086203
Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Talabostat mesylate (PT-100) tablets and Rituximab in people with Chronic Lymphocytic Leukemia, run by Point Therapeutics at 19 sites in United States.
Trial summary
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen. 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?
- Talabostat mesylate (PT-100) tablets and Rituximab
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- Start not givento Sep 2007
- Phase
- Phase 2
- 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
- Men or women ≥18 years of age
- Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
- Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
- Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
- ECOG performance status 0, 1, or 2
- Written informed consent
Who cannot join
- Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic [with the exception of hematopoietic growth factors]). Patients must have recovered from the adverse effects of prior therapy.
- Known primary or secondary malignancy of the central nervous system
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- Serum creatinine >2.0mg/dL (>176 micromol/L)
- AST or ALT ≥3 x the upper limit of normal (ULN)
- Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)
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- Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
- Known positivity for HIV
- Prior organ allograft
- Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment
- Pregnant or nursing women
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Texas Cancer Center/Abilene
Abilene, Texas, 79606-5208
Hematology/Oncology Centers of the Northern Rockies
Billings, Montana, 59101
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Raleigh Hematology/Oncology Clinic
Cary, North Carolina, 27511
Queens Medical Associates, PC
Fresh Meadows, New York, 11365
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Oncology/Hematology Consultants
Indianapolis, Indiana, 46202
Nevada Cancer Institute
Las Vegas, Nevada, 89135
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
NYU Medical Center
New York, New York, 10016
Virginia Oncology Associates-Lake Wright Cancer Center
Norfolk, Virginia, 23502
Ocala Oncology Center
Ocala, Florida, 34474
Cancer Care Associates/Oklahoma City
Oklahoma City, Oklahoma, 73112
James P. Wilmot Cancer Center/University of Rochester
Rochester, New York, 14642
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705
Cancer Care Associates--Tulsa
Tulsa, Oklahoma, 74136
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.
Read the detailed description
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Talabostat mesylate (PT-100) tablets, Rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talabostat mesylate (PT-100) tabletsDrug
RituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2004 (estimated)
- Study completionSep 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Point Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086203
- Sponsor's protocol ID
- PTH-203
- Other IDs
- FD-R-003021-01
- Status last verified
- Aug 2006
- First submitted
- 28 Jun 2004
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00086203
- Acronym / sponsor ID
- PTH-203
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Point TherapeuticsIndustry (pharma, biotech, devices)
- Study completion
- Sep 2007
- First posted
- 29 Jun 2004 (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.
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.
Detailed description
Completion date provided represents the completion date of the grant per OOPD records
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 (6 listed)
- Men or women ≥18 years of age
- Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
- Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
- Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
- ECOG performance status 0, 1, or 2
Key exclusion criteria (11 listed)
- Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic [with the exception of hematopoietic growth factors]). Patients must have recovered from the adverse effects of prior therapy.
- Known primary or secondary malignancy of the central nervous system
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- Serum creatinine >2.0mg/dL (>176 micromol/L)
- AST or ALT ≥3 x the upper limit of normal (ULN)
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 |
|---|---|---|
| Talabostat mesylate (PT-100) tablets | Drug | – |
| Rituximab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talabostat mesylate (PT-100) tablets and Rituximab in people with Chronic Lymphocytic Leukemia, run by Point Therapeutics at 19 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Mar 2015.