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Could a Gene-Targeting drug boost chemo for older leukemia patients?

NCT ID NCT00085124

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a drug called oblimersen to standard chemotherapy (daunorubicin and cytarabine) helps older adults (60+) with untreated acute myeloid leukemia live longer or achieve remission. About 500 participants were randomly assigned to receive chemo with or without oblimersen. The goal was to see if the combination improves survival and response rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

500 people

The number who actually took part.

Start date

Dec 2003

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute promyelocytic leukemia Congenital Abnormalities therapy related acute myeloid leukemia and myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult acute myeloid leukemia with 11q23 (MLL) abnormalities Adult acute myeloid leukemia with inv(16)(P13;Q22) Adult acute myeloid leukemia with T(15;17)(Q22;Q12) Adult acute myeloid leukemia with T(16;16)(P13;Q22) Adult acute myeloid leukemia with T(8;21)(Q22;Q22) Secondary acute myeloid leukemia Untreated adult acute myeloid leukemia

Contacts and locations

Locations

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.