Trial Outcomes & Findings for Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia (NCT NCT01794702)

Last Updated: 2019-05-30

Results Overview

Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

65 participants

Primary outcome timeframe

After second, 33 day cycle

Results posted on

2019-05-30

Participant Flow

Recruitment Period: 1/2013 to 01/2018

All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1: Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)

Participant milestones

Participant milestones
Measure	Period 1 Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Clofarabine: Phase I Starting Dose - 15 mg/m\^2 by vein daily for 4 days (days 6-9)	Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin Phase II - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Phase II - Clofarabine 15 mg/m\^2 by vein over approximately 1 hour for 4 days (days 6-9).
Overall Study STARTED	18	47
Overall Study COMPLETED	18	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 1 n=18 Participants Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Clofarabine: Phase I Starting Dose - 15 mg/m\^2 by vein daily for 4 days (days 6-9)	Period 2 Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Clofarabine: Phase I Dose -1 - 15 mg/m\^2 by vein daily for 3 days (days 6-9)	Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin n=47 Participants Phase II - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	0 Participants n=7 Participants	47 Participants n=5 Participants	65 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	0 Participants n=7 Participants	32 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	0 Participants n=7 Participants	33 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	—	47 participants n=5 Participants	65 participants n=4 Participants

PRIMARY outcome

Timeframe: After second, 33 day cycle

Population: All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1: Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)

Outcome measures

Outcome measures
Measure	Period 1 n=18 Participants Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily	Period 2 Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily
Maximum Tolerated Dose (MTD) of Clofarabine	15 mg/m^2 x 4 days (6-9)	—

PRIMARY outcome

Timeframe: 56 days

Population: One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.

Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.

Outcome measures

Outcome measures
Measure	Period 1 n=46 Participants Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily	Period 2 Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily
Number of Participants With a Response	20 Participants	—

SECONDARY outcome

Timeframe: Up to 2 years after participants off study date

Population: One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.

Time from date of treatment start until the date of first objective documentation of return of disease.

Outcome measures

Outcome measures
Measure	Period 1 n=46 Participants Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily	Period 2 Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily
To Determine the Disease-free Survival (DFS).	17.9 months Interval 1.0 to 33.0	—

SECONDARY outcome

Timeframe: Up to 2 years after participants off study date

Population: One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.

Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Outcome measures
Measure	Period 1 n=46 Participants Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily	Period 2 Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein over approximately 2 hours daily for 5 days (days 6-10) Clofarabine 15 mg/m\^2 by vein over approximately 1 hour daily
Overall Survival	7.7 Months Interval 1.0 to 40.0	—

Adverse Events

Period 1

Serious events: 18 serious events

Other events: 17 other events

Deaths: 1 deaths

Period 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin

Serious events: 33 serious events

Other events: 27 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Period 1 n=18 participants at risk Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Clofarabine: Phase I Starting Dose - 15 mg/m\^2 by vein daily for 4 days (days 6-9)	Period 2 Phase I Clofarabine + Cytarabine + Decitabine + Idarubicin Phase I - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Clofarabine: Phase I Dose level -1 - 15 mg/m\^2 by vein daily for 3 days (days 6-9)	Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin n=46 participants at risk Phase II - Decitabine 20 mg/m\^2 by vein for approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m\^2 by vein for approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m\^2 by vein for approximately 2 hours daily for 5 days (days 6-10) Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour for 4 days (days 6-9).
Infections and infestations Infection	5.6% 1/18 • Number of events 1 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	10.9% 5/46 • Number of events 5 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Gastrointestinal disorders Mucositis	11.1% 2/18 • Number of events 2 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	0.00% 0/46 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Gastrointestinal disorders Diarrhea	27.8% 5/18 • Number of events 5 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	2.2% 1/46 • Number of events 1 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Metabolism and nutrition disorders Hyperbilirubinemia	72.2% 13/18 • Number of events 13 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	32.6% 15/46 • Number of events 17 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Metabolism and nutrition disorders Elevated Transaminases	55.6% 10/18 • Number of events 10 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	28.3% 13/46 • Number of events 14 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Gastrointestinal disorders Nausea	16.7% 3/18 • Number of events 3 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	0.00% 0/46 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
General disorders Pain	11.1% 2/18 • Number of events 2 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	0.00% 0/46 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	0.00% 0/46 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Gastrointestinal disorders Vomiting	11.1% 2/18 • Number of events 2 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	0.00% 0/46 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
Cardiac disorders Hypotension	0.00% 0/18 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	— 0/0 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)	2.2% 1/46 • Number of events 1 • 3 years All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol. Period 1 Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2 Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)

Additional Information

Nitin Jain, MD./Associate Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-745-6080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place