AzTrials
AzTrials

LeukemiaPhase 1NCT00077493

BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

A Phase 1 study testing BL22 immunotoxin, antibody-drug conjugate therapy and immunotoxin therapy in people with Leukemia and Lymphoma, run by MedImmune LLC at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 6 months to 24 years
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
BL22 immunotoxin, antibody-drug conjugate therapy and immunotoxin therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteUnited States
Study dates
Jan 2004to Oct 2008
Phase
Phase 1
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 6 months to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

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

RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma.

PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.

Read the detailed description

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.

Conditions
Leukemia, Lymphoma
Being tested
BL22 immunotoxin, antibody-drug conjugate therapy, immunotoxin therapy, monoclonal antibody therapy
Keywords
recurrent childhood acute lymphoblastic leukemia, Burkitt lymphoma, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, childhood non-Hodgkin lymphoma
Medical subject headings
Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL22 immunotoxinDrug

    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.

  • antibody-drug conjugate therapyProcedure or surgery

    CD22 antibody, RFB4 on day 7

  • immunotoxin therapyProcedure or surgery

    tested for immunogenicity to CAT-8015 before each cycle and at end of study.

  • monoclonal antibody therapyProcedure or surgery

    administered intravenously over 30 minutes.

Study groups in NCT00077493
Study groupRoleWhat they receive
1Active comparatorBL22 immunotoxin
Receives: Drug: BL22 immunotoxin
2Active comparatorantibody therapy
Receives: Procedure: antibody-drug conjugate therapy
3Active comparatorimmunotoxin therapy
Receives: Procedure: immunotoxin therapy
4Active comparatormonoclonal antibody therapy
Receives: Procedure: monoclonal antibody therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment of efficacy, safety, pharmacokinetics, immunogenicity.

    Measured: end of study

Secondary outcomes (1)
  1. Expansion of MTD

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionOct 2008 (estimated)
  4. Study completionOct 2008 (estimated)

Why it stopped: protocol development and Amended protocol revision

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077493
Sponsor's protocol ID
CDR0000352020
Other IDs
NCI-04-C-0079H, NCI-5643
Status last verified
Dec 2007
First submitted
10 Feb 2004
Last updated
28 Dec 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL22 immunotoxin, antibody-drug conjugate therapy and immunotoxin therapy in people with Leukemia and Lymphoma, run by MedImmune LLC at 1 site 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?

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: paused, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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.

What does the primary outcome measure?

assessment of efficacy, safety, pharmacokinetics, immunogenicity. (time frame: end of study). It is what the study was designed to measure, not a finding.

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 28 Dec 2007.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in