Trial Outcomes & Findings for Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies (NCT NCT01009931)

NCT ID: NCT01009931

Last Updated: 2015-11-04

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

42 months

Results posted on

2015-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	TPA + Dexamethasone and CMT 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) 12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles. Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles. Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks. Up to 6 cycles.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TPA + Dexamethasone and CMT n=1 Participants 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) 12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles. Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles. Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks. Up to 6 cycles.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 42 months

Population: The study participant died before the study data collection completed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 43 months

Population: The study participant died before the study data collection completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 months

Population: The study participant died before the study data collection completed.

Cycle 1 of treatment

Outcome measures

Outcome data not reported

Adverse Events

TPA + Dexamethasone and CMT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TPA + Dexamethasone and CMT n=1 participants at risk 12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate) 12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles. Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles. Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks. Up to 6 cycles.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Blood	100.0% 1/1 • Number of events 2
Gastrointestinal disorders Hemorrhage, GI - Rectum	100.0% 1/1 • Number of events 1
General disorders Hemorrhage, CNS	100.0% 1/1 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Tatiana Zelinskaya

Rutgers Cancer Institute of New Jersey

Phone: (732) 235-9837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place