Trial Outcomes & Findings for Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT00602225)

NCT ID: NCT00602225

Last Updated: 2018-03-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 45 days after the last dose of clofarabine
• Results posted on: 2018-03-09

Participant Flow

Participant milestones

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline measure only applies to those participants whose disease was in relapse at the time of enrollment.

Baseline characteristics by cohort

Measure	Arm I n=50 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Age, Continuous	53 years n=50 Participants
Sex: Female, Male Female	14 Participants n=50 Participants
Sex: Female, Male Male	36 Participants n=50 Participants
AML Onset: de novo	32 Participants n=50 Participants
AML Onset: secondary	18 Participants n=50 Participants
Relapsed	32 Participants n=50 Participants
First salvage	32 Participants n=50 Participants
Second or greater salvage	18 Participants n=50 Participants
Refractory	18 Participants n=50 Participants
Favorable cytogenetics (at initial diagnosis)	3 Participants n=50 Participants
Intermediate cytogenetics (at initial diagnosis)	27 Participants n=50 Participants
Unfavorable cytogenetics (at initial diagnosis)	20 Participants n=50 Participants
Median first CR duration	26 weeks n=32 Participants • This baseline measure only applies to those participants whose disease was in relapse at the time of enrollment.

PRIMARY outcome

Timeframe: 45 days after the last dose of clofarabine

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=50 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Maximum Tolerated Dose of Clofarabine	25 mg/m^2 of clofarabine

PRIMARY outcome

Timeframe: 45 days after the last dose of clofarabine

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=50 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0	2 Participants

PRIMARY outcome

Timeframe: 45 days after the last dose of clofarabine

Population: Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.

Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=46 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Response Rates by Cytogenetic Risk Category Favorable risk Complete Remission	3 Participants
Response Rates by Cytogenetic Risk Category Intermediate risk Complete remission	10 Participants
Response Rates by Cytogenetic Risk Category Unfavorable risk Complete remission	9 Participants

PRIMARY outcome

Timeframe: 45 days after the last dose of clofarabine

Population: Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.

Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=46 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Favorable Risk + 25 mg/m^2 achieve CR	2 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Intermediate Risk + 15 mg/m^2 achieve CR	2 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Intermediate Risk + 20 mg/m^2 achieve CR	3 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Intermediate Risk + 25 mg/m^2 achieve CR	5 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Intermediate Risk + 25 mg/m^2 achieve CRp	4 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Unfavorable Risk + 15 mg/m^2 achieve CR	2 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Unfavorable Risk + 20 mg/m^2 achieve CR	1 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Unfavorable Risk + 25 mg/m^2 achieve CR	6 Participants
Response Rates by Cytogenetic Risk Category and Clofarabine Dose Unfavorable Risk + 25 mg/mg^2 achieve CRp	3 Participants

PRIMARY outcome

Timeframe: 45 days after the last dose of clofarabine

Population: Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.

Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=21 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Response Rates by Duration First Complete Remission (CR1) Duration CR1 (months): 0	12 Participants
Response Rates by Duration First Complete Remission (CR1) Duration CR1 (months): 1-6	4 Participants
Response Rates by Duration First Complete Remission (CR1) Duration CR1 (months): 6-12	2 Participants
Response Rates by Duration First Complete Remission (CR1) Duration CR1 (months): greater than 12	3 Participants

PRIMARY outcome

Timeframe: 45 days after the last dose of clofarabine

Population: Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.

Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=46 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Response Rates by Salvage Number Salvage number 1	16 Participants
Response Rates by Salvage Number Salvage number 2	5 Participants
Response Rates by Salvage Number Salvage number 3 or greater	0 Participants

SECONDARY outcome

Timeframe: 45 days after the last dose of clofarabine

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At five years after the last dose of clofarabine

Number of Patients Surviving at Five Years

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=50 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Efficacy	12 Participants

SECONDARY outcome

Timeframe: At five years after the last dose of clofarabine

Number of participants who survived and were disease-free at 5 years

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=50 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Disease-free Survival	11 Participants

SECONDARY outcome

Timeframe: At five years after the last dose of clofarabine

Outcome measures

Measure	Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC) n=50 Participants See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Overall Survival	9 months Interval 5.2 to 13.0

Adverse Events

Arm I

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=50 participants at risk See Detailed Description clofarabine: Given IV cytarabine: Given IV filgrastim: Given subcutaneously
Skin and subcutaneous tissue disorders Skin	10.0% 5/50 • Number of events 5 Other \[Non-serious\] adverse events were not collected/assessed.
Hepatobiliary disorders Hepatic transaminases	16.0% 8/50 • Number of events 8 Other \[Non-serious\] adverse events were not collected/assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary	46.0% 23/50 • Number of events 23 Other \[Non-serious\] adverse events were not collected/assessed.
Infections and infestations infection	40.0% 20/50 • Number of events 20 Other \[Non-serious\] adverse events were not collected/assessed.
Gastrointestinal disorders Gastrointestinal	12.0% 6/50 • Number of events 6 Other \[Non-serious\] adverse events were not collected/assessed.
Investigations Hyperbilirubinaemia	8.0% 4/50 • Number of events 4 Other \[Non-serious\] adverse events were not collected/assessed.
Renal and urinary disorders Renal	4.0% 2/50 • Number of events 2 Other \[Non-serious\] adverse events were not collected/assessed.
General disorders Pain	2.0% 1/50 • Number of events 1 Other \[Non-serious\] adverse events were not collected/assessed.
Nervous system disorders Neuropathy	2.0% 1/50 • Number of events 1 Other \[Non-serious\] adverse events were not collected/assessed.
Investigations Tumor Lysis	2.0% 1/50 • Number of events 1 Other \[Non-serious\] adverse events were not collected/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Pamela Becker, MD, PhD

University of Washington

Phone: 206-288-7273

Email: pbecker@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place