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Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment

Phase 2
Not Enrolling
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia

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Trial Information

Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24
doses) with provisions for dose escalation or reduction based on tolerability

Subjects are eligible for the study if they meet all of the following

Inclusion Criteria:

- Diagnosis of one of the following hematologic malignancies not responding to at least
2 standard treatment regimens. Any criteria for persistent or recurrent disease
acceptable, i.e. ≥5% blasts for acute leukemia.

- acute lymphoblastic leukemia (ALL)

- acute myeloid leukemia (AML)

- non-Hodgkin's lymphoma (NHL)

- Hodgkin's lymphoma (HL)

- multiple myeloma (MM)

- chronic lymphocytic leukemia (CLL)

- Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50%
for patients < 10 year of age

- Normal organ function within 14 days of study entry

- If female and of childbearing potential, are willing to use adequate contraception
(hormonal, barrier method, abstinence) prior to study entry and for the duration of
study participation. A female is considered to be of childbearing potential unless
she has had her uterus removed, had a double oophorectomy, or has been amenorrheic
for at least 6 months after chemotherapy

Exclusion Criteria:

- Had/have the following prior/concurrent therapy:

- Systemic corticosteroids (oral or injectable) within 7 days of first dose of
852A (topical or inhaled steroids are allowed)

- Investigational drugs/agents within 14 days of first dose of 852A

- Immunosuppressive therapy, including cytotoxic agents within 14 days of first
dose of 852A (nitrosoureas within 30 days of first dose)

- Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes
unless best available drug required to treat life-threatening conditions

- Radiotherapy within 4 weeks of the first dose of 852A

- Hematopoietic cell transplantation 4 weeks of first dose of 852A

- Active infection or fever > 38.5°C within 3 days of first dose of 852A

- Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by

- History of, or clinical evidence of, a condition which, in the opinion of the
investigator, could confound the results of the study or put the subject at undue

- Uncontrolled intercurrent or chronic illness

- Active autoimmune disease requiring immunosuppressive therapy within 30 days

- Active hepatitis B or C with evidence of ongoing viral replication

- Hyperthyroidism

- Uncontrolled seizure disorder

- Active coagulation disorder not controlled with medication

- Pregnant or lactating

- Concurrent malignancy (if in remission, at least 5 years disease free) except for
localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas
adequately treated

- Proven active central nervous system (CNS) disease

- Human Immunodeficiency Virus (HIV) positive

- Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males
and > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square
root of the RR interval in seconds) on screening electrocardiogram (ECG).

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors

Outcome Description:

Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.

Outcome Time Frame:

Up to Week 12

Safety Issue:


Principal Investigator

Sarah Cooley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

November 2008

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Lymphoma
  • Myeloma
  • Hematology
  • 852A
  • IRM
  • Oncology
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455