Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Plain-language summary

This randomized Phase 3 trial by the National Cancer Institute (NCI) compared daunorubicin and cytarabine with or without oblimersen sodium (G3139, a bcl-2 antisense oligodeoxynucleotide, Genasense) in older patients with previously untreated acute myeloid leukemia (AML). Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to them, and it was not yet known which approach works better. Eligible patients had histologically confirmed AML without promyelocytic leukemia; a history of antecedent myelodysplasia was allowed if no prior cytotoxic therapy had been given for it. The trial is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

National Cancer Institute (NCI)

Intervention

oblimersen sodium (augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense), cytarabine (ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside), daunorubicin hydrochloride (Cerubidin, Cerubidine, daunomycin hydrochloride, daunorubicin, RP-13057), laboratory biomarker analysis

Start date

12/1/2003

Countries

United States

Related genes

Locations

• Chicago, United States
• Columbus, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* DISEASE CHARACTERISTICS:

  * Histologically confirmed acute myeloid leukemia
  * No promyelocytic leukemia
  * History of antecedent myelodysplasia allowed provided that the patient received no prior cytotoxic therapy for myelodysplastic syndromes
* PRIOR CONCURRENT THERAPY:

  * Biologic therapy

    * Prior growth factor and/or cytokine support allowed
    * No concurrent routine or prophylactic myeloid growth factors
  * Chemotherapy

    * No prior chemotherapy for leukemia or myelodysplasia except under the following conditions:
    * Emergency leukapheresis
    * Emergency treatment for hyperleukocytosis with hydroxyurea
    * No other concurrent chemotherapy
  * Endocrine therapy

    * No concurrent hormones except steroids for adrenal failure or hormones for non-disease-related conditions allowed (e.g., insulin for diabetes)
  * Radiotherapy

    * Prior cranial radiotherapy for CNS leukostasis (1 dose only) allowed
    * No concurrent palliative radiotherapy
  * Surgery
  * Not specified
  * Other

    * Concurrent enrollment on CALGB-8461, CALGB-9665, and CALGB-9760 allowed
    * No other concurrent investigational or commercial agents or therapies intended to treat the malignancy