Neoplasms

Blood and Lymph Conditions

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Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Leukemia, Hairy Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphosarcoma

Hairy Cell Leukemia

All Drugs and Chemicals

Immunotoxins

Immunoconjugates

Immunologic Factors

BL22 immunotoxin

Robert Kreitman, MD

RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.

PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.

OBJECTIVES:

* Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22+ hairy cell leukemia.
* Define the pharmacokinetics of this drug, including the terminal elimination serum half-life area under the curve and volume of distribution, in these patients.
* Evaluate the immunogenicity of this drug in these patients.
* Determine the effect of this drug on various components of the circulating cellular immune system in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 courses in the absence of disease progression and sufficient neutralizing antibodies.

Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.

Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

National Cancer Institute (NCI)

Symptoms and General Pathology

Infections

Recurrence

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Burkitt Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunotoxin HA22

Immunoglobulins, Intravenous

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 therapy

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

immunotoxin therapy

administered intravenously over 30 minutes.

monoclonal antibody therapy

Alan S. Wayne, MD

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.

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.

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

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

Cambridge Antibody Technology

MedImmune LLC

Karen Kaucic, M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia	NCT00021983	Leukemia	BL22 immunotoxi...	18 Years -	National Cancer Institute (NCI)
Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia	NCT00021983	Leukemia	BL22 immunotoxi...	18 Years -	National Cancer Institute (NCI)
BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma	NCT00077493	Leukemia Lymphoma	BL22 immunotoxi... antibody-drug c... immunotoxin the... monoclonal anti...	6 Months - 24 Years	MedImmune LLC

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