Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Recurrence

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Disease Attributes

Lymphoma, Non-Hodgkin

Leukemia, B-Cell

Chronic Disease

Chronic Graft Versus Host Disease

Lymphosarcoma

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

B-cell Lymphoma

Marginal Zone Lymphoma

Acute Graft Versus Host Disease

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Immunologic Factors

Patients receive apolizumab IV over at least 2 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen.

apolizumab

laboratory biomarker analysis

pharmacological study

John Byrd

Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) or biological effective dose of monoclonal antibody Hu1D10 (apolizumab) in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

II. Determine the safety of this drug, in terms of frequency and severity of treatment-related adverse events, in this patient population.

SECONDARY OBJECTIVES:

I. Determine whether this drug has anti-leukemia/lymphoma activity in patients expressing the Hu1D10 antigen.

II. Determine the pharmacokinetics of this drug in this patient population. III. Determine whether the infusion-related toxicity of this drug is secondary to cytokine release in these patients.

IV. Determine whether the intensity of 1D10 target antigen on tumor cells is related to clinical response and treatment toxicity in these patients.

V. Determine the pharmacodynamics of this drug in this patient population.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (chronic lymphocytic leukemia or small lymphocytic lymphoma vs acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\]). Patients with ALL or AML are enrolled after the maximum tolerated dose (MTD) is determined.

Patients receive apolizumab IV over at least 2 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen.

Cohorts of 3-6 patients receive escalating doses of MOAB Hu1D10 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT). If no DLT is observed, the biological effective dose (BED) is determined in the above cohorts. The BED is defined as the dose at which at least 4 of 6 patients experience an acceptable minimum trough level and clinical response. An additional 24 patients (12 per stratum) are treated at the MTD.

Patients are followed at 1 week, 1 and 2 months, and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 35 patients (12 per stratum) will be accrued for this study.

Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia

Phase I Study of Thrice Weekly Hu1D10*in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Acute Leukemia

Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Nevertheless, low statistical power will greatly limit these analyses.

National Cancer Institute (NCI)

Hodgkin Disease

Hodgkin Lymphoma

Sandra J. Horning, MD

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.

OBJECTIVES:

* Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10.
* Determine the duration of response and progression-free survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 5 and 8 and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within approximately 12 months.

Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma

A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease

Stanford University

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Diffuse Large B-Cell Lymphoma

Mantle Cell Lymphoma

Follicular Lymphoma

Antirheumatic Agents

Rituximab

Apolizumab followed by rituixmab every 4 weeks

Apolizumab IV on Day 1. Administer weekly for 4 weeks

Apolizumab

Rituximab IV 24-36 hours after Apolizumab ends. Administer weekly for 4 weeks

Wyndham H Wilson, M.D.

This study will evaluate the safety and effectiveness of a combination of two antibodies, apolizumab and rituximab (Rituxan ), in treating B-cell lymphomas and chronic lymphocytic leukemia. Rituximab attaches to a molecule called CD20 on B-cell lymphomas and can cause significant shrinkage of these tumors in up to half of patients. However, it does not cure the lymphoma, which usually returns. Also, it is not as effective against leukemia. Apolizumab attaches to a protein called 1D10 on B-cell cancers and has also been able to shrink tumors in some patients. There is little experience apolizumab in patients with leukemia. This study will test whether the two antibodies together are more effective against these tumors than either one alone.

Patients 18 years and older with B-cell lymphoma or chronic lymphocytic leukemia may be eligible for this study. Patients' leukemia or lymphoma cells must have both the CD20 and 1D10 antigen receptors and must have had at least one systemic treatment for their disease. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, x-rays and other imaging studies, and possibly a bone marrow aspirate (withdrawal of a small marrow sample through a needle inserted into the hip bone) and lumbar puncture (withdrawal of a small sample of cerebrospinal fluid-fluid that bathes the brain and spinal cord-through a needle placed between the bones in the lower back).

Participants receive infusions of rituximab and apolizumab once a week for 4 weeks. The first patients in the study receive lower doses of apolizumab with standard doses of rituximab. If the apolizumab is well tolerated, subsequent patients are given higher doses. Patients are also given dexamethasone or another similar steroid, diphenhydramine (Benadryl ), and acetominophen (Tylenol ) to reduce reactions to the antibodies. After 4 weeks of treatment, patients are followed frequently to examine the response to treatment and evaluate drug side effects. Patients whose tumors do not grow during the 4 weeks of therapy may be offered another course of treatment at a later time. Participants are followed periodically after treatment ends until their disease worsens or the study ends.

...

While recurrent non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL) are often responsive to therapy, they are rarely curable and disease control is the primary therapeutic goal. Rituximab, a chimeric anti-CD20 monoclonal antibody, has shown single agent activity in these diseases and is currently approved for the therapy of recurrent indolent lymphoma. However, rituximab induces objective remission in at most 60% of cases with inevitable relapse. The 1D10 antigen, a subclass of the HLA-DR molecule, is expressed in a majority of cases of B-cell malignancy. Apolizumab is a humanized monoclonal antibody that targets this antigen. In a phase I dose escalation trial this antibody has shown clinical activity against B-cell NHL that express the 1D10 antigen. Acute infusional toxicity has been tolerable, and a maximum of 5 mg/kg has been given in each of 4 weekly doses. Preclinical in vitro data from Dr. George Weiner's laboratory suggests at least additive anti-tumor efficacy when cells are exposed to both antibodies simultaneously. This trial will pilot the use of combination therapy with rituximab and apolizumab in patients with tumors that express both antigens. Feasibility and tolerability of the regimen will be determined. Experimental endpoints will include pharmacokinetics of apolizumab, assessment of apoptosis in circulating CLL cells by FACS analysis with Annexin 5, assessment of T-and B-cell dynamics, and effects of rituximab and apolizumab on CLL mRNA as measured by cDNA microarray. Following the first 21 patients on trial, the administration sequence of rituximab and apolizumab was changed from rituximab first to apolizumab first to potentially reduce sensitization of apolizumab toxicity by rituximab.

Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia

Combination Antibody Therapy With Apolizumab (1D10) and Rituximab (CD20) in Relapsed Lymphoma and CLL

Infections

Burkitt Lymphoma

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphoma, Large-cell, Immunoblastic

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Brian Link, MD

Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

OBJECTIVES:

I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.

II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.

III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.

IV. Evaluate any antilymphoma effects of this drug in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression.

Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia	NCT00017472	Extranodal Marg... Nodal Marginal ... Noncontiguous S... Noncontiguous S... Recurrent Adult... Recurrent Adult... Recurrent Margi... Recurrent Small... Refractory Chro... Splenic Margina... Stage III Margi... Stage III Small... Stage IV Margin... Stage IV Small ...	apolizumab laboratory biom... pharmacological...	18 Years -	National Cancer Institute (NCI)
Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma	NCT00055783	Lymphoma	apolizumab	18 Years -	National Cancer Institute (NCI)
Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia	NCT00022971	Diffuse Large B... Follicular Lymp... Chronic Lymphoc... Mantle Cell Lym... Small Lymphocyt...	Apolizumab Rituximab	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma	NCT00004101	Lymphoma	apolizumab	18 Years -	National Cancer Institute (NCI)
Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia	NCT00022971	Diffuse Large B... Follicular Lymp... Chronic Lymphoc... Mantle Cell Lym... Small Lymphocyt...	Apolizumab Rituximab	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma	NCT00004101	Lymphoma	apolizumab	18 Years -	National Cancer Institute (NCI)
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma	NCT00004101	Lymphoma	apolizumab	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for apolizumab

Every month we try and update this database with for apolizumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for apolizumab

Every month we try and update this database with for apolizumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for apolizumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.