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Adult leukemia patients get Kid-Style chemo combo in new trial

NCT ID NCT01920737

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether a combination of chemotherapy drugs typically used in children can be safe and effective for adults aged 18 to 60 with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The study aims to see if this 'pediatric-inspired' regimen helps achieve deep remission with fewer side effects. Thirty-nine participants are receiving a multi-drug regimen over several phases, with close monitoring for response and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
combination chemotherapy (daunorubicin, vincristine, prednisone, PEG-asparaginase, methotrexate, 6-mercaptopurine, cyclophosphamide, cytarabine, leucovorin, dexamethasone)
What this could lead to
If successful, this could offer a more effective and safer chemotherapy regimen for adults with Ph-negative ALL, potentially improving remission rates.
What could go wrong
This is a small, early-phase (phase 2) study with only 39 participants. The regimen may not work as well in adults as in children, and side effects could be significant.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Start date

Aug 2013

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 60 years

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: * Previously untreated Ph negative precursor B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain Patients who have untreated B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain, but Ph status is unknown, may also enroll. * Patients with T-cell or B cell lymphoblastic lymphoma confirmed by conventional immature T- or pre B cell markers even if the bone marrow is not involved are also eligible * Age 18 - 60 years * ECOG performance status of 0-2 * Adequate renal function as demonstrated by a serum creatinine ≤ 2.0 mg/dl or a creatinine clearance of \> 60 ml/min. * Adequate hepatic function as demonstrated by a total bilirubin \< 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia * Normal cardiac function as demonstrated by a left ventricular ejection fraction ≥ 50% on echocardiogram or MUGA scan * Negative serum pregnancy test in women of childbearing potential * Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished. * Patients with central nervous system involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days. Exclusion Criteria: * Previous treatment for ALL, except for prior steroids and/or hydroxyurea * Patients known to have Philadelphia (Ph)+ ALL are not eligible. Leukemia cell samples will be obtained from all patients enrolled before starting protocol treatment and submitted for Philadelphia chromosome testing by either karyotyping, or for bcr/abl1 translocation by FISH or by PCR for bcr/abl1. Patients who are later found to have Ph+ ALL should have treatment on this trial discontinued and will not be considered in the evaluation * Lymphoid blastic crisis of chronic myelogenous leukemia * Mature B-cell (Burkitt's) ALL * Active serious infections not controlled by antibiotics * Pregnant women or women who are breast-feeding * Concurrent active malignancy requiring immediate therapy * Clinically significant cardiac disease (NY Heart Association Class III or IV), including chronic arrhythmias, or pulmonary disease * Known HIV positive status * Other serious or life-threatening conditions deemed unacceptable by the principal investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27701, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Weill Cornell Medical Center

    New York, New York, United States

More trials for these conditions

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