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AzTrials

LeukemiaPhase 2NCT01920737

A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

A Phase 2 study testing Daunorubicin, Vincristine and Prednisone in people with Leukemia, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Leukemia
What is being tested?
Daunorubicin, Vincristine and Prednisone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesUnited States
Study dates
7 Aug 2013to Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke University Medical Center

    Durham, North Carolina, 27701

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical Center

    New York, New York

Other trials in United States

About this study

The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy drugs that are given in different combinations and in several steps. In adult ALL there is no standard which drugs to give and how to combine them. Some leukemias have a chromosome abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do not (called Ph Negative). In this study we want to see whether this combination of chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative ALL.

Conditions
Leukemia
Being tested
Daunorubicin, Vincristine, Prednisone, PEG-Asparaginase, Methotrexate
Keywords
ALL, Bone Marrow, Ph Negative, Daunorubicin, Vincristine, Prednisone, PEG-Asparaginase, Methotrexate, 16-MP (6-Mercaptopurine), Cyclophosphamide, Cytarabine, Leucovorin, Dexamethasone, 12-266
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01920737
Study groupRoleWhat they receive
Leukemia PatientsExperimentalThe treatment plan has 6 treatment cycles. The cycle names are listed in the following order: Induction Phase I - Induction Phase II - Intensification I - Re-induction I - Intensification II - Re-induction II Each cycle is given over a period of 4-6 weeks and the interval between them can range between 1-3 weeks. Based the patients medical condition, the doctor may decide to change the timing of the drugs, the interval between the drugs in a cycle, or the interval between the cycles. After receiving all cycles you will continue with a 36 months treatment part that is called Maintenance.
Receives: Drug: Daunorubicin; Drug: Vincristine; Drug: Prednisone; Drug: PEG-Asparaginase; Drug: Methotrexate; Drug: 6-MP (6-Mercaptopurine); Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Leucovorin; Drug: Dexamethasone; Other: Blood draw; Device: CT/PET scans

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of molecular remission

    i.e. minimal residual disease (MRD) negative status, as assessed by PCR and flow cytometry in the bone marrow after phase I induction.

    Measured: 1 year

Secondary outcomes (6)

  1. complete remission (CR)

    All three criteria must be met for clinical complete remission:

    • Peripheral Blood Counts. The absolute neutrophil count should be ≥1,000/μl (sustained without growth factor support), and platelet count should be ≥100,000/μl (without transfusions), and no circulating blasts. After Induction remission assessment, blood counts are considered recovered at ANC ≥ 1,000 and PLT ≥75,000.
    • Bone Marrow Aspirate. Bone marrow cellularity should be approximate normal with evidence of maturation of all cell lineages and should contain <5% blasts.
    • Extramedullary Leukemia, such as CNS or soft tissue involvement, must not be present. If the patient had CNS involvement by ALL at the time of starting the study, the CNS involvement should be re-examined and interval determined by the treating physicians in order to determine if clinical complete remission

    Measured: 1 year

  2. overall survival (OS)

    OS will be calculated from the start of induction therapy to death or last follow-up.

    Measured: 1 year

  3. event-free survival (EFS)

    EFS survival will be calculated from the start of induction therapy to relapse (molecular or clinical), death, or last follow-up.

    Measured: 1 year

  4. disease free survival (DFS) rates

    DFS will be calculated from the time of clinical CR (or better) to relapse (molecular or clinical), death, or last follow-up.

    Measured: 1 year

  5. minimal residual disease (MRD) status

    Molecular relapse is defined as the conversion of RT-PCR from MRD negative to MRD positive on two consecutive tests performed on bone marrow at least one week apart, while still meeting criteria for clinical CR.

    Measured: 1 year

  6. safety

    Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be tabulated.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2013 (estimated)
  2. Study start7 Aug 2013
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01920737
Sponsor's protocol ID
12-266
Status last verified
Sep 2026
First submitted
7 Aug 2013
Last updated
15 Sep 2026
Results posted
No

Publications

  • Geyer MB, Ritchie EK, Rao AV, Vemuri S, Flynn J, Hsu M, Devlin SM, Roshal M, Gao Q, Shukla M, Salcedo JM, Maslak P, Tallman MS, Douer D, Park JH. Pediatric-inspired chemotherapy incorporating pegaspargase is safe and results in high rates of minimal residual disease negativity in adults up to age 60 with Philadelphia chromosome-negative acute lymphoblastic leukemia. Haematologica. 2021 Aug 1;106(8):2086-2094. doi: 10.3324/haematol.2020.251686.

    PubMed 33054114

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daunorubicin, Vincristine and Prednisone in people with Leukemia, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of molecular remission (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01920737, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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