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NCT01463852
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation Status in Patients With Chronic Lymphocytic Leukemia (CLL)
EARLY_PHASE1 trial testing vincristine in Chronic Lymphocytic Leukemia (CLL) in 11 participants. Terminated before completion.
1 December 2014
Quick facts
| Lead sponsor | Dartmouth-Hitchcock Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 11 |
| Start date | 1 October 2012 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- vincristine (vincristine) — full drug profile →
Conditions studied
- Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →
Sponsor
Dartmouth-Hitchcock Medical Center
Who can join
18 and older, any sex, with Chronic Lymphocytic Leukemia (CLL). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
c-Jun N-terminal Kinase (JNK) activation
Time frame: Change in JNK activation from baseline up to 6 hours post dose
blood draws are collected pre-vincristine and at 10 minutes,1,2,4,and 6 hours post vincristine.
Sponsor's own description
In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are scheduled to initiate treatment per the recommendations of their primary oncologist, will receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this single dose will induce rapid cell death in isolated CLL cells. Vincristine 2 mg will be administered to the participants intravenously over 5 minutes. Blood samples will be collected from an intravenous line inserted into the contralateral limb to that where the vincristine was given, at time zero (pre-vincristine treatment), immediately after vincristine administration (within 2-10 minutes upon completion of administration) and at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at a later date receive chemotherapy treatment as prescribed by their primary oncologist. Within 7 days of vincristine administration, participants will receive a phone call from the research nurse to discuss potential toxicities. At the time of the initiation of standard chemotherapy treatment, the Principal Investigator will also meet with the participant to collect information regarding adverse events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01463852
- 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.
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- NCT03229746 — Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia · Phase 4 · completed
- NCT02809573 — Clinical Trial of Chidamide Combined With CHOP in Peripheral T-cell Lymphoma Patients · Phase 1 · completed
- NCT02639650 — Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor · Phase 3 · unknown
Other recruiting trials for Chronic Lymphocytic Leukemia (CLL)
Currently open trials in the same condition.
- NCT07428707 — Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib · EARLY_PHASE1 · recruiting
- NCT07205315 — A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-p · EARLY_PHASE1 · recruiting
- NCT06788639 — A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisoca · recruiting
- NCT05908409 — A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies · Phase 1, PHASE2 · recruiting
- NCT05724121 — Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax · recruiting
Other Dartmouth-Hitchcock Medical Center trials
Trials by the same sponsor.
- NCT07325474 — Plan and Protect: Safety Planning for Teens in Rural Emergency Departments · NA · not yet recruiting
- NCT07428629 — Piloting an Insomnia Treatment in Patients With Ulcerative Colitis · NA · not yet recruiting
- NCT06777511 — Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients · not yet recruiting
- NCT07279116 — ABY-029 Head & Neck Trial · Phase 1 · not yet recruiting
- NCT07063693 — ABY-029 Glioma Trial · Phase 1 · recruiting
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 NCT01463852 (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 Dartmouth-Hitchcock Medical Center
- Last refreshed: 8 May 2015
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/NCT01463852.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing