Trial Outcomes & Findings for TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients (NCT NCT00415909)

Last Updated: 2014-06-30

Results Overview

Rate is defined as number of participants with response of Major and Complete cytogenetic response out of total study participants. Response evaluated at one and 3 months from start of therapy, then every 3 months in patients with response, for one year, then every 6-12 months. Responses classified according to suppression of Philadelphia (Ph) chromosome by cytogenetic analysis: a) Complete cytogenetic response - Not Ph positive; b) Major cytogenetic response - Ph positive 1-34% of pretreatment value; c) Minor cytogenetic response - Ph positive 35-65% of pretreatment value; d) Minimal cytogenetic response - Ph positive 65-99% of pretreatment value; e) No cytogenetic response - Ph positive 100% of pretreatment value.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Evaluated at baseline (pretreatment) up to 12 months

Results posted on

2014-06-30

Participant Flow

Recruitment Period: December 21, 2006 to June 27, 2008.

Participant milestones

Participant milestones
Measure	TALL-104 + IM TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	TALL-104 + IM TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
Overall Study Withdrawal by Subject	2
Overall Study Death	1

Baseline Characteristics

TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TALL-104 + IM n=3 Participants TALL-104 cells and imatinib mesylate (IM) therapy Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
Age, Continuous	65 years n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 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	2 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

PRIMARY outcome

Timeframe: Evaluated at baseline (pretreatment) up to 12 months

Population: All three patients received the planned 9 administrations of TALL-104.

Outcome measures

Outcome measures
Measure	TALL-104 + IM n=3 Participants TALL-104 cells and imatinib mesylate (IM) therapy Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
Response Rate (Major and Complete Cytogenetic Response) Baseline	0 percentage of participants
Response Rate (Major and Complete Cytogenetic Response) 1 Month	67 percentage of participants
Response Rate (Major and Complete Cytogenetic Response) 3 Months	33 percentage of participants
Response Rate (Major and Complete Cytogenetic Response) 12 Months	33 percentage of participants

Adverse Events

TALL-104 + IM

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TALL-104 + IM n=3 participants at risk TALL-104 cells and imatinib mesylate (IM) therapy Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
General disorders Death	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.

Other adverse events

Other adverse events
Measure	TALL-104 + IM n=3 participants at risk TALL-104 cells and imatinib mesylate (IM) therapy Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
General disorders Fatigue	66.7% 2/3 • Number of events 2 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Investigations Fever	66.7% 2/3 • Number of events 2 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Skin and subcutaneous tissue disorders Hyperpigmentation	66.7% 2/3 • Number of events 2 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Musculoskeletal and connective tissue disorders Muscle Weakness	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Vascular disorders Edema, Limb	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Skin and subcutaneous tissue disorders Hypopigmentation	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Musculoskeletal and connective tissue disorders Musculoskeletal, Other	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Eye disorders Occular/Visual	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Musculoskeletal and connective tissue disorders Pain, Extremity-Limb	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
Nervous system disorders Pain, Headache	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.
General disorders Pain, Other	33.3% 1/3 • Number of events 1 • Treatment cycle is 28 days, follow up planned for 1, 3 and 6 months. Overall study period was from January 2007 to November 2012.

Additional Information

Jorge Cortes, MD / Professor, Leukemia

University of Texas MD Anderson Cancer Center

Phone: 713-794-5783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place