Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies
Verified July 2014 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: March 25, 2010
Last updated: July 14, 2014
Last verified: July 2014
The goal of the clinical research study is to find the highest tolerable dose of nelarabine when given as a continuous infusion to patients with a lymphoid malignancy that has not responded to, or has come back after treatment with chemotherapy. The safety of this drug will also be studied.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pharmacokinetic and Pharmacodynamic Study to Evaluate the Safety and Feasibility of Continuous Infusion Nelarabine in Patients With Relapsed / Refractory Lymphoid Malignancies
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2016 (Final data collection date for primary outcome measure)
Experimental: Continuous Infusion Nelarabine
Starting dose 200 mg/m2 x 5 days
Starting dose 200 mg/m2 for 5 day continuous infusion administered via a central catheter, repeated every 28 days.
Other Name: Arranon
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have one of the following relapsed/ refractory lymphoid malignancies: Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) or B-prolymphocytic leukemia which has been previously treated with a purine analog, and are not candidates for higher priority clinical studies. Follicular lymphoma, mantle cell lymphoma, lymphoplasmacytoid lymphoma or marginal zone lymphoma which has been previously treated with autologous or allogeneic stem cell transplantation.
- Continued from #1:T-cell prolymphocytic leukemia, large granular lymphocyte leukemia, mycosis fungoides / Sezary syndrome or peripheral T-cell lymphoma which has been previously treated with at least one line of chemotherapy or monoclonal antibody therapy. T-cell or B-cell acute lymphoblastic leukemia (ALL) which has been previously treated with at least one line of chemotherapy.
- Patients (both pediatrics and adults) must have adequate renal function (calculated creatinine clearance >/= 50ml/min). For adults this will be calculated per the Cockcroft-Gault formula and in pediatric cases this will be calculated per the Schwartz formula.
- Patients must have adequate hepatic function (bilirubin </= 2 mg/dL; SGOT or SGPT </= 3X the ULN for the reference lab unless due to leukemia).
- Patients must have adequate marrow function (neutrophils >/= 0.5x10^9/L and platelets >/= 50x10^9/L) unless cytopenias are deemed due to disease.
- Patients must have adequate performance status (Zubrod 0-2).
- Female patients must not be pregnant or lactating. Female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
- Patients must not have untreated or uncontrolled life-threatening infection.
- Patients known to be HIV positive or known to have Hepatitis B and/or C are excluded.
- Patients must not have received systemic chemotherapy or monoclonal antibody therapy within 2 weeks of study enrollment. Patients who have previously received bolus nelarabine are still eligible. Hydroxyurea or corticosteroids for control of blood counts is allowed, but must be discontinued 24 hours prior to initiating nelarabine.
- Patients must not have a history of grade >/=2 neurological toxicity with previous treatment, or persistent grade >/=2 peripheral neuropathy. Drowsiness and lethargy were exempted from this criteria unless previously persistent for more than one week.
- Patients must not have uncontrolled central nervous system disease. Patients with a history of seizure disorders must be seizure-free for one year prior to enrollment.
- Patients must not have any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094860
|Contact: Tapan Kadia, MD
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
|Principal Investigator: Tapan Kadia, MD |
M.D. Anderson Cancer Center
||Tapan Kadia, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 25, 2010
||July 14, 2014
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Relapsed/Refractory Lymphoid Malignancies
Chronic lymphocytic leukemia
Small lymphocytic lymphoma
Mantle cell lymphoma
Marginal zone lymphoma
T-cell prolymphocytic leukemia
large granular lymphocyte leukemia
peripheral T-cell lymphoma
Monoclonal antibody therapy
T-cell or B-cell acute lymphoblastic leukemia (ALL)
Continuous Infusion Nelarabine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Neoplasms by Histologic Type