Last reviewed · How we verify
NCT06175702: LALPh2022
Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL
trial testing Vincristine in Lymphoblastic Leukemia in 150 participants. Not yet recruiting.
25 December 2028
Quick facts
| Lead sponsor | PETHEMA Foundation |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 25 December 2023 |
| Primary completion | 25 December 2028 |
| Estimated completion | 25 December 2030 |
Drugs / interventions tested
- Vincristine
- Dexamethasone (dexamethasone) — full drug profile →
- Imatinib — full drug profile →
- Cytarabine — full drug profile →
- Mercaptopurine
- Methotrexate
- Ponatinib
- allogeneic stem cell transplantation
- Total body irradiation
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
Conditions studied
- Lymphoblastic Leukemia — all drugs for Lymphoblastic Leukemia →
- Philadelphia-Positive ALL — all drugs for Philadelphia-Positive ALL →
- Adult ALL — all drugs for Adult ALL →
Sponsor
PETHEMA Foundation
Who can join
18 and older, any sex, with Lymphoblastic Leukemia or Philadelphia-Positive ALL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved combinations of chemotherapy and tyrosine kinase inhibitor (TKI). Efficay refers to the rate of Complete Molecular Response (BCR::ABL1/ABL1 ratio 0.01%) in eah treatment arm. Safety refers to measurement of i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests), ii) incidence and degree of cytopenias and iii) incidence and degree of infections. Low-dose chemotherapy will be given together with the TKI imatinib to patients of all ages as induction to remission phase. Consolidation treatment will continue with low-dose chemotherapy with imatinib if the patient fullfills both criteria: to show a measurable residual disease (MRD) value lower than 0,01% at 3 month of therapy, and not showing IKZF1plus genetics Those patients have any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy plus ponatinib as TKI and allogeneic stem cell transplantation (allo SCT). The remaining patients (standard-risk) will receive maintenance chemotherapy together with imatinib or ponatinib and will not be submitted to alloSCT.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06175702
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vincristine
Trials testing the same drug.
- NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
- NCT07133997 — Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refrac · Phase 1 · recruiting
- NCT06738368 — Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombin · Phase 2 · recruiting
- NCT07493148 — Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL · Phase 2 · recruiting
Other recruiting trials for Lymphoblastic Leukemia
Currently open trials in the same condition.
- NCT06961669 — Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma · NA · recruiting
- NCT06207123 — A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leuke · Phase 1, PHASE2 · recruiting
- NCT05194397 — Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors · Phase 2 · recruiting
- NCT05043571 — CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia · Phase 1 · recruiting
- NCT05038696 — ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia. · Phase 1 · recruiting
Other PETHEMA Foundation trials
Trials by the same sponsor.
- NCT07443592 — Treatment for Ph-negative ALL for Adults up to 65 Years · NA · not yet recruiting
- NCT07045909 — Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) · Phase 2 · recruiting
- NCT06574126 — Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma · Phase 2 · recruiting
- NCT06544785 — Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Phase 2 · recruiting
- NCT05218603 — Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Predniso · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06175702 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PETHEMA Foundation
- Last refreshed: 19 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06175702.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing