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Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies

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ClinicalTrials.gov Identifier: NCT01094860
Recruitment Status : Active, not recruiting
First Posted : March 29, 2010
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Nelarabine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Pharmacodynamic Study to Evaluate the Safety and Feasibility of Continuous Infusion Nelarabine in Patients With Relapsed / Refractory Lymphoid Malignancies
Actual Study Start Date : June 2010
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Continuous Infusion Nelarabine
Starting dose 200 mg/m2 x 5 days
Drug: Nelarabine
Starting dose 200 mg/m2 for 5 day continuous infusion administered via a central catheter, repeated every 28 days.
Other Name: Arranon




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of a 5-day Continuous Infusion Schedule of Nelarabine [ Time Frame: 28 day cycle ]
    MTD defined as the highest dose that no more than 1 dose limiting toxicity (DLT) occurs among 6 patients. Dose-limiting toxicity (DLT) defined based on drug related events only. DLT in the first treatment cycle used for the dose escalation.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Patients must have adequate hepatic function (bilirubin </= 2 mg/dL; SGOT or SGPT </= 3X the ULN for the reference lab unless due to leukemia).
  5. Patients must have adequate marrow function (neutrophils >/= 0.5x10^9/L and platelets >/= 50x10^9/L) unless cytopenias are deemed due to disease.
  6. Patients must have adequate performance status (Zubrod 0-2).
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Patients must not have untreated or uncontrolled life-threatening infection.
  2. Patients known to be HIV positive or known to have Hepatitis B and/or C are excluded.
  3. 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.
  4. 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.
  5. 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 enrolment.
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094860


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
GlaxoSmithKline
Investigators
Study Chair: Tapan Kadia, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01094860     History of Changes
Other Study ID Numbers: 2009-0717
NCI-2010-01659 ( Registry Identifier: NCI CTRP )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Relapsed/Refractory Lymphoid Malignancies
Chronic lymphocytic leukemia
CLL
Small lymphocytic lymphoma
SLL
B-prolymphocytic leukemia
Follicular lymphoma
Mantle cell lymphoma
Lymphoplasmacytoid lymphoma
Marginal zone lymphoma
T-cell prolymphocytic leukemia
large granular lymphocyte leukemia
mycosis fungoides
Sezary syndrome
peripheral T-cell lymphoma
Chemotherapy
Monoclonal antibody therapy
T-cell or B-cell acute lymphoblastic leukemia (ALL)
Continuous Infusion Nelarabine
Arranon

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type