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Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

StatusRecruiting
PhasePhase 2
Started2016-06
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 21, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-10-20
Study Status v19
Primary completion date2025-10-01→2026-10-01
Completion date2025-12→2026-12
2025-07-23
Study Status v18
Re-verified, no change to tracked fields
2024-07-17
Study Status v17
Primary completion date2024-07→2025-10-01
Completion date2025-07→2025-12
2023-10-02
Study Status v16
Primary completion date2023-07→2024-07
Completion date2023-07→2025-07
2022-11-02
Study Status v15
Primary completion date2022-07→2023-07
Show 14 earlier versions
2021-08-13
Study Status v14
Primary completion date2021-07→2022-07
2021-05-21
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
2020-10-20
Study Status v12
Primary completion date2020-07→2021-07
2020-02-03
Study Status v11
Primary completion date2020-01→2020-07
Completion date2023-01→2023-07
2019-04-23
Study Status, Eligibility v10
Eligibility criteriarevised
[...] l Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 5045%, no clinical congestive heart failure Pulmonary: no eviden [...]
2018-09-25
Study Status v9
Re-verified, no change to tracked fields
2018-07-12
Study Status, Eligibility v8
Eligibility criteria+374 characters
Less than 30 years of age at diagnosis of neuroblastoma No evidenceEnd of Induction disease progression:evaluation defineddemonstrating asCR, increasePR, in tumor size of >25%MR or newSD Hematopoietic lesions Recovery from last induction course of chemotherapy No uncon [...] up are strongly recommended (thus, PBSC of no less than 6 x 10610^6 CD34 cells/kg is encouraged). These must all be collected p [...] ation of consolidation. Adequate organ function defined as: --Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional normal and alanine aminotransferase (ALT) < 3 x upper limit of in [...] [...]
2018-04-24
3 amendments v5-v7
3 re-verifications since 2017-10-04, no change to tracked fields
2017-02-17
Study Status, Oversight, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2016-12-07
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2016-06-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2016-05-06
Study Status, Outcome Measures v1
Start date2016-01→2016-06
Secondary endpoints3 entries, revised
Number of patients who relapsedRelapse
Primary endpoints1 entry, revised
Rate of Progression Free Survival
2015-11-12
Original filing
This is a phase II single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.
Trial Details
NCT Number NCT02605421
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Neuroblastoma
Enrollment 12 participants
Start Date 2016-06
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-21