Completed

Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)

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What is being tested

Talabostat mesylate (PT-100) tablets

+ Rituximab
Drug
Who is being recruted

Chronic Lymphocytic Leukemia

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional

See protocol details

Summary

Principal SponsorPoint Therapeutics
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

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. Completion date provided represents the completion date of the grant per OOPD records

Official TitleStudy of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL) 
Principal SponsorPoint Therapeutics
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Lymphocytic Leukemia
Criteria

INCLUSION CRITERIA: * 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 EXCLUSION CRITERIA: * 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) * 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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 19 locations
Suspended
University of Arkansas for Medical ScienceLittle Rock, United StatesSee the location
Suspended
Ocala Oncology CenterOcala, United States
Suspended
Gulfcoast Oncology AssociatesSt. Petersburg, United States
Suspended
Indiana Oncology/Hematology ConsultantsIndianapolis, United States
Completed19 Study Centers