Trial Outcomes & Findings for 17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma (NCT NCT00117988)

Last Updated: 2014-05-30

Results Overview

Number of participants who experience complete response or partial response. Partial Response=\>50% decrease in lympho node masses. Complete Response=\>-75% decrease in lymph node masses.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Baseline to time to best response; Every 6 weeks

Results posted on

2014-05-30

Participant Flow

Recruitment Period: 02/08/2005 through 05/08/2009. All participant recruitment attempted at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	17-AAG 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m\^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
Overall Study STARTED	22
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	17-AAG 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m\^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
Overall Study Death	3
Overall Study Adverse Event	1

Baseline Characteristics

17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	17-AAG n=22 Participants 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m\^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
Age, Continuous	49.5 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to time to best response; Every 6 weeks

Population: Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included.

Number of participants who experience complete response or partial response. Partial Response=\>50% decrease in lympho node masses. Complete Response=\>-75% decrease in lymph node masses.

Outcome measures

Outcome measures
Measure	17-AAG n=18 Participants 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m\^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
Number of Patients With Response Complete Response	0 participants
Number of Patients With Response Partial Response	2 participants

Adverse Events

17-AAG

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	17-AAG n=22 participants at risk 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m\^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
General disorders Death	13.6% 3/22 • 4 years and 1 month

Other adverse events

Other adverse events
Measure	17-AAG n=22 participants at risk 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m\^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
Gastrointestinal disorders Diarrhea	36.4% 8/22 • 4 years and 1 month
General disorders Fatigue	31.8% 7/22 • 4 years and 1 month
Gastrointestinal disorders Nausea	27.3% 6/22 • 4 years and 1 month
General disorders Pain	22.7% 5/22 • 4 years and 1 month
Gastrointestinal disorders Vomiting	22.7% 5/22 • 4 years and 1 month
General disorders Fever	27.3% 6/22 • 4 years and 1 month
Nervous system disorders Neuropathy	22.7% 5/22 • 4 years and 1 month
Metabolism and nutrition disorders Hypomagnesemia	18.2% 4/22 • 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 4/22 • 4 years and 1 month
Eye disorders Blurred Vision	13.6% 3/22 • 4 years and 1 month
Cardiac disorders Hypertension	13.6% 3/22 • 4 years and 1 month
Cardiac disorders Hypotension	9.1% 2/22 • 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • 4 years and 1 month
Metabolism and nutrition disorders Hypokalemia	9.1% 2/22 • 4 years and 1 month
Skin and subcutaneous tissue disorders Pruritus	9.1% 2/22 • 4 years and 1 month

Additional Information

Dr. Anas Younes, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60