Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01463852
Other study ID # D11199
Secondary ID
Status Terminated
Phase Phase 0
First received October 31, 2011
Last updated May 8, 2015
Start date October 2012
Est. completion date December 2014

Study information

Verified date February 2014
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female, 18 years old or older.

2. A diagnosis of Chronic Lymphocytic Leukemia(CLL) which is CD5/CD19/CD23 positive, confirmed by peripheral blood immunophenotyping and/or lymph node biopsy and immunophenotyping and/or bone marrow biopsy and immunophenotyping. CD23-negative CLL cases are eligible, however additional diagnostic confirmation should include absence of Cyclin D1 rearrangement [t(11;14)] as determined by standard laboratory methods (such as fluorescent in situ hybridization).

3. Patients are planning to start chemotherapy for CLL recommended and prescribed by their primary oncologist.

4. Peripheral blood lymphocyte count above 20,000/mm3

5. Be able to provide written informed consent

Exclusion Criteria

1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

2. Patients who are receiving any other investigational agents.

3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to vincristine.

4. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

5. Liver function test abnormalities of = grade 3 (total bilirubin >3 ULN (upper limit of normal), AST> 5 ULN, ALT> 5 ULN) as per CTCAE 4.0 criteria, or direct bilirubin = 3.0 mg/dL

6. Pre-existing neuropathy grade 2 or greater as per CTCAE 4.0 criteria (moderate symptoms limiting instrumental activities of daily living - ADLs)

7. Patients who are pregnant or planning to become pregnant during their participation in the study.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
vincristine
Vincristine 2mg will be administered one time to participants. Blood samples will be collected pre and post dose.

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center Lebanon New Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary c-Jun N-terminal Kinase (JNK) activation blood draws are collected pre-vincristine and at 10 minutes,1,2,4,and 6 hours post vincristine. Change in JNK activation from baseline up to 6 hours post dose No
See also
  Status Clinical Trial Phase
Recruiting NCT03588598 - Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies Phase 1
Recruiting NCT06043011 - Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Completed NCT02265731 - Study Evaluating Venetoclax in Subjects With Hematological Malignancies Phase 1/Phase 2
Completed NCT02582879 - informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Completed NCT02553304 - Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients
Completed NCT01419691 - Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL) Phase 2
Completed NCT01188681 - Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia Phase 1/Phase 2
Recruiting NCT04758975 - Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL) Phase 2
Terminated NCT02914938 - A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma Phase 1
Active, not recruiting NCT01976520 - Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Phase 1
Terminated NCT01203930 - A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL Phase 2
Recruiting NCT02966756 - A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Phase 2
Active, not recruiting NCT05105841 - Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Phase 2
Recruiting NCT04072458 - A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies Phase 1
Withdrawn NCT01754870 - Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab (Rituxan®) and Lenalidomide (Revlimid®) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01885897 - IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT Phase 1/Phase 2
Active, not recruiting NCT04830137 - A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies Phase 1
Recruiting NCT03547115 - A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML Phase 1
Active, not recruiting NCT04285567 - A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation Phase 3

External Links