Clinical trial · Interventional

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

A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense, Oblimersen Sodium, NSC #683428, IND #58842), a BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated Patients With Acute Myeloid Leukemia (AML) > / = 60 Years

NCT00085124CI-TRIAL-00113076completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see how well they work compared to daunorubicin and cytarabine in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.

Conditions

Conditions (7)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities	—	UNRESOLVED	—
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)	—	UNRESOLVED	—
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)	—	UNRESOLVED	—
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)	Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11	ALIAS	0.90
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1	ALIAS	0.85
Secondary Acute Myeloid Leukemia	Secondary Acute Myeloid Leukemia	ONTOLOGY_EXACT	0.98
Untreated Adult Acute Myeloid Leukemia

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
cytarabine	Drug	Cytarabine	ALIAS
daunorubicin hydrochloride	Drug	Daunorubicin	ALIAS
laboratory biomarker analysis	Other	—	UNRESOLVED
oblimersen sodium	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I
description
Remission induction therapy: Patients receive oblimersen IV continuously on days 1-10, cytarabine IV continuously on days 4-10, and daunorubicin IV on days 4-6. Patients who achieve CR proceed to consolidation therapy. Patients who do not achieve CR receive a second course of induction therapy. Second remission induction therapy: Patients receive oblimersen IV continuously on days 1-8, cytarabine IV continuously on days 4-8, and daunorubicin IV on days 4-5. Patients who achieve CR proceed to consolidation therapy. Consolidation therapy: Patients receive oblimersen IV continuously on days 1-8 and high-dose cytarabine IV over 3 hours on days 4-8. Patients with a continuing CR receive a second course of consolidation therapy.
interventionNames
1. Biological: oblimersen sodium
2. Drug: cytarabine
3. Drug: daunorubicin hydrochloride
4. Other: laboratory biomarker analysis
type
EXPERIMENTAL
label
Arm II
description
Remission induction therapy: Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3. Patients who achieve CR proceed to consolidation therapy. Patients who do not achieve CR receive a second course of induction therapy. Second remission induction therapy: Patients receive cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1 and 2. Patients who achieve CR proceed to consolidation therapy. Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours on days 1-5. Patients with a continuing CR receive a second course of consolidation therapy.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 60 Years

Show eligibility criteria text

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

References

Publications (4)

DERIVEDSeffernick AE, Mrozek K, Nicolet D, Stone RM, Eisfeld AK, Byrd JC, Archer KJ. High-dimensional genomic feature selection with the ordered stereotype logit model. Brief Bioinform. 2022 Nov 19;23(6):bbac414. doi: 10.1093/bib/bbac414. PMID 36184192
DERIVEDWalker AR, Marcucci G, Yin J, Blum W, Stock W, Kohlschmidt J, Mrozek K, Carroll AJ, Eisfeld AK, Wang ES, Jacobson S, Kolitz JE, Thakuri M, Sutamtewagul G, Vij R, Stuart RK, Byrd JC, Bloomfield CD, Stone RM, Larson RA. Phase 3 randomized trial of chemotherapy with or without oblimersen in older AML patients: CALGB 10201 (Alliance). Blood Adv. 2021 Jul 13;5(13):2775-2787. doi: 10.1182/bloodadvances.2021004233. PMID 34251414
DERIVEDWalker CJ, Kohlschmidt J, Eisfeld AK, Mrozek K, Liyanarachchi S, Song C, Nicolet D, Blachly JS, Bill M, Papaioannou D, Oakes CC, Giacopelli B, Genutis LK, Maharry SE, Orwick S, Archer KJ, Powell BL, Kolitz JE, Uy GL, Wang ES, Carroll AJ, Stone RM, Byrd JC, de la Chapelle A, Bloomfield CD. Genetic Characterization and Prognostic Relevance of Acquired Uniparental Disomies in Cytogenetically Normal Acute Myeloid Leukemia. Clin Cancer Res. 2019 Nov 1;25(21):6524-6531. doi: 10.1158/1078-0432.CCR-19-0725. Epub 2019 Aug 2. PMID 31375516
DERIVEDYin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112. PMID 31171508

Registry

Dates and enrollment

Start: Dec 1, 2003
Primary completion: Jun 1, 2007
Completion: —
First posted: Jun 11, 2004
Last update posted: Jun 1, 2026
Enrollment: 500 (actual)
Lead sponsor: National Cancer Institute (NCI) NIH

Data updated 22 days agoSource updated Jun 1, 2026source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.