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Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies

Phase 1
18 Years
Not Enrolling
Hematologic Malignancies

Thank you

Trial Information

Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies

Inclusion Criteria:

- Patients must have one of the following: acute myeloid or lymphoid leukemia; or
Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or
Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or
Multiple Myeloma

- Patients with acute leukemia must meet one of the following conditions:

*have disease which is refractory to a course of standard induction chemotherapy
*have relapsed diseased after documentation of previous clinical remission or *have
untreated disease and not be a candidate for conventional first line treatment

- Patients with CML or other MPD must have evidence of accelerated phase or blast

- Patients having clinical features of CML in transformation but who are negative for
Philadelphia chromosome may be entered provided there is a prior definable chronic

- Patients with Philadelphia chromosome positive CML must have failed treated with
Gleevec (Imatinib) in order to be eligible for study

- Patients with myelodysplastic syndrome (MDS) must have > 5% blasts in the peripheral
blood or bone marrow and have at diagnosis as IPSS score of >= 1

- Patients with CLL must have relapsed or refractory disease after at least three
courses of conventional therapy and have been determined to no longer be a candidate
for conventional therapy

- Patients with non-Hodgkin's lymphoma (other than CLL) must have relapsed or
refractory disease after at least two courses of chemotherapy and have been
determined not to be a candidate for further conventional therapies

- Patients with multiple myeloma must have failed at least 3 prior therapies

- Performance Status 0, 1 or 2

- Serum creatinine < 2.0 mg/dl; serum bilirubin < 2 mg/dl and AST/ALT < 3.0 x upper
limit of normal

- PTT within normal range

- Age > 18

- Patients must have an indwelling central venous catheter

Exclusion Criteria:

- Significant cardiac disease which requires active therapy

- Intercurrent organ damage or medical problems that will jeopardize outcome of therapy

- Pregnant or lactating females

- Received prior c-myb AS ODN therapy

- Patients with suitable HLA identical sibling donor who are deemed to be appropriate
and willing candidates for allogeneic bone marrow transplantation

- Patients requiring anticoagulation with unfractionated heparin.

Type of Study:


Study Design:

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

Outcome Measure:

Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN

Outcome Time Frame:

At study completion

Safety Issue:


Principal Investigator

Selina Luger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania Abramson Cancer Center


United States: Food and Drug Administration

Study ID:

UPCC 04701



Start Date:

September 2002

Completion Date:

August 2011

Related Keywords:

  • Hematologic Malignancies
  • Hematologic Malignancies
  • c-myb
  • c-myb AS ODN
  • Neoplasms
  • Hematologic Neoplasms



University of Pennsylvania Abramson Cancer Center Philadelphia, Pennsylvania  19104