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A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol


Phase 2
18 Years
N/A
Not Enrolling
Both
Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Stage III Small Lymphocytic Lymphoma, Stage IV Small Lymphocytic Lymphoma

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Trial Information

A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol


PRIMARY OBJECTIVES:

I. Determine the response rate and progression-free survival rate in patients with relapsed
or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or
IV small lymphocytic lymphoma treated with apolizumab.

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

SECONDARY OBJECTIVES:

I. Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine
if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual
patient CLL cell and how apolizumab clearance correlates with response and selected
toxicities observed.

III. To determine the importance of reactive oxygen species and specific signaling pathways
in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if
this correlates with clinical response to therapy.

IV. To determine the cellular properties which convey resistance to apolizumab in CLL in
vivo.

OUTLINE: This is a multicenter study.

Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22,
24, and 26 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then
every 6 months for 3 years.


Inclusion Criteria:



- Histologically confirmed hematologic malignancy of 1 of the following histologies:

- Chronic lymphocytic leukemia (CLL)

- Small lymphocytic lymphoma (SLL)

- Noncontiguous stage II or stage III or IV disease

- Received >= 1 form of prior immunotherapy or chemotherapy

- Completed therapy at least 4 weeks ago

- Requires therapy (unless early bone marrow transplantation is planned), as indicated
by 1 of the following criteria:

- Progressively worsening disease (symptoms increasing in severity by 1 toxicity
criterion over a period of >= 2 weeks)

- Progressively worsening anemia or thrombocytopenia

- Progressively worsening lymphadenopathy

- Massive splenomegaly or hypersplenism

- Hyperlymphocytosis (WBC > 200,000/mm^3) OR lymphocyte doubling time < 12 months

- Marrow failure due to marrow infiltration by leukemia or lymphoma

- Leukemia cells must express 1D10 antigen > 2 times mean fluorescent intensity of the
control by flow cytometry of blood or bone marrow cells

- Performance status - ECOG 0-2

- At least 2 years

- Platelet count >= 50,000/mm^3 (transfusion independent)

- Bilirubin =< 3 mg/dL (unless due to tumor involvement)

- Creatinine =< 2.0 mg/dL

- No decompensated congestive heart failure

- No unstable angina

- No myocardial infarction within the past 6 months not corrected by surgery or
percutaneous transluminal coronary angioplasty

- No active infection requiring oral or IV antibiotics

- No other malignancy that limits life expectancy to < 2 years or that requires active
anticancer therapy within 4 weeks of study entry

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study treatment

- Recovered from prior immunotherapy

- More than 3 months since prior alemtuzumab or rituximab

- No prior apolizumab

- Recovered from prior chemotherapy

- More than 4 weeks since prior anticancer hormonal therapy

- More than 4 weeks since prior anticancer radiotherapy

- More than 4 weeks since prior anticancer surgery

- At least 4 weeks since other prior therapy for CLL or SLL and recovered

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (CR+PR)

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

John Byrd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01454

NCT ID:

NCT00089154

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Noncontiguous Stage II Small Lymphocytic Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Stage III Small Lymphocytic Lymphoma
  • Stage IV Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210
Chronic Lymphocytic Leukemia Research Consortium (CRC) La Jolla, California  92093-0820