Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01920737 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 2
Started2013-08-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-16
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2026-08 → 2027-08
2025-09-09
Study Status, Oversight, Contacts/Locations v26
Primary completion date2025-08→2026-08
Completion date2025-08→2026-08
Start date2013-08→2013-08-07
Study sites4→3
2025-02-26
Study Status, Oversight v25
Re-verified, no change to tracked fields
2024-09-03
Study Status v24
Primary completion date2024-08→2025-08
Completion date2024-08→2025-08
2023-10-23
Study Status v23
Primary completion date2023-08→2024-08
Completion date2023-08→2024-08
Show 22 earlier versions
2022-11-07
Study Status v22
Re-verified, no change to tracked fields
2022-09-01
Study Status v21
Primary completion date2022-08→2023-08
Completion date2022-08→2023-08
2021-09-01
Study Status v20
Primary completion date2021-08→2022-08
Completion date2021-08→2022-08
2020-09-29
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v19
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
2020-09-08
Study Status v18
Primary completion date2020-08→2021-08
Completion date2020-08→2021-08
2019-09-04
Study Status v17
Primary completion date2019-08→2020-08
Completion date2019-08→2020-08
2018-09-04
Study Status v16
Primary completion date2018-08→2019-08
Completion date2018-08→2019-08
2018-01-02
Study Status v15
Re-verified, no change to tracked fields
2017-09-06
Study Status v14
Primary completion date2017-08→2018-08
Completion date2017-08→2018-08
2017-08-08
2 amendments v12-v13
2 re-verifications since 2017-04-26, no change to tracked fields
2017-01-19
Study Status v11
Completion datenot stated→2017-08
2016-10-18
Study Status, Sponsor/Collaborators, Arms and Interventions, Contacts/Locations v10
Interventions6-MP (6-Mercaptopurine) (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin (Drug), Dexamethasone (Drug), Leucovorin (Drug)…→6-MP (6-Mercaptopurine) (Drug), Blood draw (Other), CT/PET scans (Device), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin (Drug)…
Study sitesdetails revised at 1 of 4 sites
Collaborators4 entries, revised
Sigma-Tau Research, Inc.Shire
2016-06-08
Study Status, Sponsor/Collaborators, Contacts/Locations v9
Study sites3→4
Collaborators3 to 4 entries
Lehigh Valley Health Network
2016-01-13
Study Status, Contacts/Locations v8
Primary completion date2016-08→2017-08
Study sitescontacts updated at 1 of 3 sites
2015-08-05
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 3 sites
2015-05-20
Study Status v6
Re-verified, no change to tracked fields
2015-01-29
Study Status, Outcome Measures, Eligibility, References v5
Eligibility criteria+321 characters
[...] 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 als [...] 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 treatm [...] [...]
Secondary endpointsdetails revised at 1 of 6 entries
2014-08-13
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 3 sites
2014-03-19
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 3 sites
2014-02-26
Study Status, Arms and Interventions v2
Re-verified, no change to tracked fields
2013-09-11
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v1
Eligibility criteria+230 characters
[...] 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 lymphoblastic lymphoma confirmed by co [...] tment for ALL, expect for prior steroids and/or hydroxyurea Patients known to have Philadelphia (Ph)+ ALL are not eligible. Leukemia cell sampl [...] abl1 translocation by FISH or by PCR for bcr/abl1. Patients identifiedwho asare later found to have Ph+ willALL beshould takenhave offtreatment theon studythis trial disconti [...] [...]
2013-08-08
Original filing
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.
Trial Details
NCT Number NCT01920737
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Shire, Duke University, Weill Medical College of Cornell University, Lehigh Valley Health Network
Conditions Leukemia
Enrollment 39 participants
Start Date 2013-08-07
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-15