Trial Outcomes & Findings for Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors (NCT NCT00365768)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Up to 30 weeks from baseline while on Vincristine treatment

Results posted on

2016-09-09

Participant Flow

All subjects were consented according to Institutional Review Board approved guidelines during out routine outpatient or inpatient stay. The period of recruitment was from January 2007 to July 2011.

Fifty-six patients were enrolled and 49 were evaluable, with the reasons for removal from study after randomization due to: change in clinical status (N=3), family withdrew (N=2), family relocation (N=1) and other (N=1). 49 patients were randomized to the glutamine or placebo arm.

Participant milestones

Participant milestones
Measure	Arm I: Glutamine Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Glutamine: Administered orally twice daily for 21 days	Arm II: Placebo Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Placebo: Administered orally twice daily for 21 days
Overall Study STARTED	24	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I: Glutamine n=24 Participants Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Glutamine: Administered orally twice daily for 21 days	Arm II: Placebo n=25 Participants Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Placebo: Administered orally twice daily for 21 days	Total n=49 Participants Total of all reporting groups
Age, Continuous	11 years n=5 Participants	10 years n=7 Participants	11 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 weeks from baseline while on Vincristine treatment

Outcome measures

Outcome measures
Measure	Arm I: Glutamine n=24 Participants Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Glutamine: Administered orally twice daily for 21 days	Arm II: Placebo n=25 Participants Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Placebo: Administered orally twice daily for 21 days
Incidence of Vincristine-induced Peripheral Neuropathy	24 participants	25 participants

SECONDARY outcome

Timeframe: 42 days

Outcome measures

Outcome measures
Measure	Arm I: Glutamine n=24 Participants Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Glutamine: Administered orally twice daily for 21 days	Arm II: Placebo n=25 Participants Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Placebo: Administered orally twice daily for 21 days
Number of Participants With Progression of Neuropathy	11 participants	19 participants

Adverse Events

Arm I: Glutamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia Glade-Bender, MD

Columbia University Medical Center

Phone: 212-305-3379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place