Suspended

Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas

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What is being tested

BL22 immunotoxin

+ antibody-drug conjugate therapy
+ immunotoxin therapy
Drug
Procedure
Who is being recruted

Hematologic Diseases
+6

+ Immune System Diseases
+ Immunoproliferative Disorders
From 6 Months to 24 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorMedImmune LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma. * Determine the maximum tolerated dose of this drug in these patients. * Determine the immunogenicity of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia. * Determine the therapeutic efficacy of this drug in inducing remissions in these patients. * Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug. OUTLINE: This is a non-randomized, dose-escalation study. Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, the cohort is expanded and a total of 12 patients are treated at that dose. Patients are followed weekly for at least 1 month and then every 1-3 months thereafter. PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study.

Official TitlePediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas 
NCT00075309NCT00077493
Principal SponsorMedImmune LLC
Last updated: January 14, 2026
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
95 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 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.
From 6 Months to 24 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
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma) * Not amenable to available curative therapies * Relapsed or refractory disease after at least 1 standard chemotherapy and 1 salvage regimen * CD22 positive according to at least 1 of the following criteria: * More than 15% CD22-positive malignant cells by immunohistochemistry * More than 30% CD22-positive malignant cells by fluorescent-activated cell sorter analysis * Measurable or evaluable disease * Prior CNS involvement allowed provided there is no current evidence of CNS malignancy * No CNS leukemia or lymphoma as manifested by any of the following: * Cerebrospinal fluid (CSF) WBC ≥ 5/mm\^3 and confirmation of CSF blasts * Cranial neuropathies secondary to underlying malignancy * Radiologically detected CNS lymphoma * No isolated testicular ALL * Ineligible for or refused hematopoietic stem cell transplantation OR has disease activity that prohibits the time required to identify a suitable stem cell donor PATIENT CHARACTERISTICS: Age * 6 months to 24 years Performance status * ECOG 0-3 (12 to 24 years of age) * Lansky 40-100% (under 12 years of age) Life expectancy * Not specified Hematopoietic * See Disease Characteristics * Absolute neutrophil count \> 1,000/mm\^3 \* * Platelet count \> 50,000/mm\^3 \* NOTE: \*Non-leukemic patients only Hepatic * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 5 times upper limit of normal * No active hepatitis B or C infection Renal * Creatinine normal for age OR * Creatinine clearance ≥ 60 mL/min Immunologic * No serum neutralization of more than 75% of the activity of 1 µg/mL of study drug * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant unrelated systemic illness that would preclude study participation * No other significant organ dysfunction that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) * Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) allowed * More than 100 days since prior allogeneic HSCT Chemotherapy * See Disease Characteristics * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * Concurrent corticosteroids allowed provided there has been no increase in the dose 1 week prior to and after study entry * Steroid taper allowed Radiotherapy * At least 3 weeks since prior radiotherapy * Allowed in the past 3 weeks provided the volume of the bone marrow treated is \< 10% AND the patients has measurable disease outside of the radiation port Surgery * Not specified Other * Recovered from prior therapy * At least 30 days since prior investigational drugs * No other concurrent investigational drugs


Study Plan

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

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
BL22 immunotoxin

BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.
Group II
Active Comparator
antibody therapy

CD22 antibody, RFB4 on day 7
Group III
Active Comparator
immunotoxin therapy

tested for immunogenicity to CAT-8015 before each cycle and at end of study.
Group IV
Active Comparator
monoclonal antibody therapy

administered intravenously over 30 minutes.
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

SuspendedOne Study Center
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