Suspended

Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia

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What is being tested

Clofarabine

Drug
Who is being recruted

Chronic Lymphocytic Leukemia

+ Leukemia
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2004

See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: August 1, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL). 2. To determine the toxicity profile of clofarabine in CLL. 3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL. Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical examination. You will also be asked about what medications you are taking currently and about the level of your daily activities. Routine blood tests (about 2 tablespoons) will be done within 14 days before the start of the study to make sure that you are not at increased risk for developing side effects. You may have bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. If you are found to be eligible, you will receive clofarabine as a 1-hour infusion into a vein once once every 2 weeks for 4 weeks. This cycle makes up one treatment course. The drug is evaluated at different dose levels. The first three patients will start with a lower dose. Unless serious side effects occur, the next group of patients (usually groups are 3 patients, although they can be expanded to include more patients if needed) will receive a higher dose. If you show a response and do not experience any severe side effects, you can receive up to a total of 6 courses of therapy. During each course, clofarabine is given the same way as during the first course. However, the dose of clofarabine may be lowered during later courses to decrease the risk of side effects that may have occurred in previous courses. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. Before every treatment course, your doctor will perform a physical exam, including measurement of your weight and vital signs. You will be asked about the level of your daily activities and how you are feeling. At least once every two weeks (more often if your doctor feels it is necessary), you will have blood samples (about 1-2 teaspoons) collected for routine lab tests. Repeat bone marrows will be collected after the third and sixth course. However, if you complete the study before the third course, the bone marrow may be taken then. No bone marrow may be taken if the condition of your disease is obvious from the blood. You will need to stay in Houston for the first 4 weeks of treatment. After that, you may return to your home but you will still have to return to Houston to receive the clofarabine treatment. You may choose to have check-up visits and blood tests with your local doctor. After you finished your treatment, and as long you are participating on this study, you will be scheduled every 3-6 months to check on the status of the disease and your overall health. This is an investigational study. Clofarabine is authorized by the FDA for use in research only. Up to 36 participants will take part in this study. All will be enrolled at M. D. Anderson.

Official TitlePhase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia 
Principal SponsorM.D. Anderson Cancer Center
Last updated: August 1, 2012
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
8 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
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 effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

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.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Lymphocytic Leukemia
Leukemia
Criteria
4 inclusion criteria required to participate
Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen
Absolute neutrophil count (ANC) >= 1 x 10(9)/L and platelet count \>= 50 x 10(9)/L
Adequate liver function (total bilirubin <= 1.5 x ULN, SGPT \<= 2.5 x ULN) and renal function (serum creatine \<= 1.5 x ULN)
ECOG performance status <= 2
7 exclusion criteria prevent from participating
Patients with NYHA >= grade 3 heart disease as assessed by history and/or physical examination
Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception
Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy)
Other malignancy within 3 years except in situ carcinoma

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

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 1 location
Suspended
The University of Texas M.D. Anderson Cancer CenterHouston, United StatesSee the location
SuspendedOne Study Center