Completed

BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

BL22

Drug
Who is being recruted

Leukemia

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003

Summary

Principal SponsorMedImmune LLC
Last updated: June 22, 2010
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia that has not responded to treatment with cladribine. PURPOSE: This phase II trial is studying BL22 immunotoxin to see how well it works in treating patients previously treated with cladribine for hairy cell leukemia. OBJECTIVES: Primary * Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin. Secondary * Determine the response duration in patients treated with this drug. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients. OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest. Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR without minimal residual disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses beyond CR. Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Official TitlePhase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia 
Principal SponsorMedImmune LLC
Last updated: June 22, 2010
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
36 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.
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
Leukemia
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed hairy cell leukemia * CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody * Meets at least 1 of the following indications for treatment: * Absolute neutrophil count less than 1,000/mm\^3 * Hemoglobin less than 10 g/dL * Platelet count less than 100,000/mm\^3 * Absolute lymphocyte count greater than 20,000/mm\^3 * Symptomatic splenomegaly * Meets 1 of the following response criteria: * No response * Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine * CR or PR less than 4 years in duration after a second or later course of prior cladribine PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Bilirubin no greater than 2.2 mg/dL * Albumin at least 3.0 g/dL Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness that would preclude study participation * Understand and give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * No prior BL22 immunotoxin * More than 12 weeks since prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy * More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day) Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent investigational agents


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
BL22 immunotoxin
Study Objectives
Primary Objectives

Secondary 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
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, United StatesSee the location

CompletedOne Study Center