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Article ; Online: Real-world outcomes of adult patients with acute lymphoblastic leukemia treated with a modified CALGB 10102 regimen.

Reed, Daniel R / Wooster, Margaux / Isom, Scott / Ellis, Leslie R / Howard, Dianna S / Manuel, Megan / Dralle, Sarah / Lyerly, Susan / Bhave, Rupali / Powell, Bayard L / Pardee, Timothy S

Annals of hematology

2023 Volume 102, Issue 4, Page(s) 897–906

Abstract: Acute lymphoblastic leukemia (ALL) is an aggressive bone marrow cancer with disparate outcomes. Data on patient outcomes in real world settings outside of clinical trials is limited. The current study reports on outcomes for 137 ALL patients who received ...

Abstract	Acute lymphoblastic leukemia (ALL) is an aggressive bone marrow cancer with disparate outcomes. Data on patient outcomes in real world settings outside of clinical trials is limited. The current study reports on outcomes for 137 ALL patients who received an adult induction and consolidation regimen derived from the CALGB 10102 trial modified without alemtuzumab. Of the 137 patients, 32 were < 40 years old, 52 were between 40 and 59, and 53 were ≥ 60 years old. Overall, 109 (79.6%) patients achieved a complete remission (< 40: 96.1%, 40-59: 86.5%, and 62.3% ≥ 60 (p = 0.0002)). Progression free survival for the entire cohort was 13.5 months and by age was 19.8 months for less than 40, 23.4 months for 40 to 59 and 6.7 months for ≥ 60; p = 0.0002. Median survival was 22.1 months for the entire cohort (32.9 months for ages < 40, 26.6 months ages 40-59, 7.8 months ≥ 60, p < 0.001).
MeSH term(s)	Humans ; Adult ; Child, Preschool ; Infant ; Middle Aged ; Treatment Outcome ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy ; Remission Induction ; Alemtuzumab/therapeutic use
Chemical Substances	Alemtuzumab (3A189DH42V)
Language	English
Publishing date	2023-03-01
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1064950-5
ISSN	1432-0584 ; 0939-5555 ; 0945-8077
ISSN (online)	1432-0584
ISSN	0939-5555 ; 0945-8077
DOI	10.1007/s00277-023-05141-5
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Article ; Online: A Pilot Phase II Study of the Feasibility and Efficacy of Vincristine Sulfate Liposome Injection in Patients With Relapsed or Refractory Acute Myeloid Leukemia.

Seegars, Mary Beth / Woods, Ryan / Ellis, Leslie R / Bhave, Rupali Roy / Howard, Dianna S / Manuel, Megan / Dralle, Sarah / Lyerly, Susan / Powell, Bayard L / Pardee, Timothy S

Journal of hematology

2021 Volume 10, Issue 1, Page(s) 1–7

Abstract: Background: Resistance to therapy and a poor outcome characterize relapsed or refractory acute myeloid leukemia (AML). There is a clear need for additional palliative approaches with acceptable toxicities. Vincristine sulfate liposome injection (VSLI) ... ...

Abstract	Background: Resistance to therapy and a poor outcome characterize relapsed or refractory acute myeloid leukemia (AML). There is a clear need for additional palliative approaches with acceptable toxicities. Vincristine sulfate liposome injection (VSLI) confers enhanced pharmacokinetics and activity when compared to the parent compound. It is effective and well tolerated in heavily pretreated acute lymphoblastic leukemia (ALL) patients. Preclinically VSLI has activity in vincristine-resistant cancers. As relapsed or refractory AML patients would have minimal exposure to vincristine it was hypothesized that VSLI would be well tolerated and may have activity. Methods: A pilot phase II clinical trial was conducted. Five patients with relapsed or refractory disease were treated using the Food and Drug Administration (FDA)-approved dose and schedule. Results: Of the five patients treated none completed more than one cycle; there were no responses and two patients did not complete one cycle of therapy. Surprisingly, three of the five patients had treatment-related constipation, and two had neuropathy consistent with the known toxicities of VSLI. Given the toxicity and lack of response, the trial was terminated early. Conclusions: VSLI had no activity against relapsed or refractory AML in this limited, single institution dataset.
Language	English
Publishing date	2021-02-06
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2662519-2
ISSN	1927-1220 ; 1927-1220
ISSN (online)	1927-1220
ISSN	1927-1220
DOI	10.14740/jh771
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Article ; Online: Phase II trial of cytarabine and mitoxantrone with devimistat in acute myeloid leukemia.

Anderson, Rebecca / Miller, Lance D / Isom, Scott / Chou, Jeff W / Pladna, Kristin M / Schramm, Nathaniel J / Ellis, Leslie R / Howard, Dianna S / Bhave, Rupali R / Manuel, Megan / Dralle, Sarah / Lyerly, Susan / Powell, Bayard L / Pardee, Timothy S

Nature communications

2022 Volume 13, Issue 1, Page(s) 1673

Abstract: Devimistat is a TCA cycle inhibitor. A previously completed phase I study of devimistat in combination with cytarabine and mitoxantrone in patients with relapsed or refractory AML showed promising response rates. Here we report the results of a single ... ...

Abstract	Devimistat is a TCA cycle inhibitor. A previously completed phase I study of devimistat in combination with cytarabine and mitoxantrone in patients with relapsed or refractory AML showed promising response rates. Here we report the results of a single arm phase II study (NCT02484391). The primary outcome of feasibility of maintenance devimistat following induction and consolidation with devimistat in combination with high dose cytarabine and mitoxantrone was not met, as maintenance devimistat was only administered in 2 of 21 responders. The secondary outcomes of response (CR + CRi) and median survival were 44% (21/48) and 5.9 months respectively. There were no unexpected toxicities observed. An unplanned, post-hoc analysis of the phase I and II datasets suggests a trend of a dose response in older but not younger patients. RNA sequencing data from patient samples reveals an age-related decline in mitochondrial gene sets. Devimistat impairs ATP synthesis and we find a correlation between mitochondrial membrane potential and sensitivity to chemotherapy. Devimistat also induces mitochondrial reactive oxygen species and turnover consistent with mitophagy. We find that pharmacological or genetic inhibition of mitochondrial fission or autophagy sensitizes cells to devimistat. These findings suggest that an age related decline in mitochondrial quality and autophagy may be associated with response to devimistat however this needs to be confirmed in larger cohorts with proper trial design.
MeSH term(s)	Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Caprylates ; Cytarabine/therapeutic use ; Humans ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/genetics ; Mitoxantrone ; Sulfides ; Treatment Outcome
Chemical Substances	Caprylates ; Sulfides ; Cytarabine (04079A1RDZ) ; Mitoxantrone (BZ114NVM5P) ; devimistat (E76113IR49)
Language	English
Publishing date	2022-03-30
Publishing country	England
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-022-29039-4
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Article ; Online: Efficacy of 10-day decitabine in acute myeloid leukemia.

Bouligny, Ian M / Mehta, Vivek / Isom, Scott / Ellis, Leslie R / Bhave, Rupali R / Howard, Dianna S / Lyerly, Susan / Manuel, Megan / Dralle, Sarah / Powell, Bayard L / Pardee, Timothy S

Leukemia research

2021 Volume 103, Page(s) 106524

Abstract: The azanucleotide decitabine is used in the treatment of acute myeloid leukemia (AML). Studies have shown conflicting results with 10-day regimens used in previously untreated AML patients. Additionally, there is little data on 10-day decitabine regimens ...

Abstract	The azanucleotide decitabine is used in the treatment of acute myeloid leukemia (AML). Studies have shown conflicting results with 10-day regimens used in previously untreated AML patients. Additionally, there is little data on 10-day decitabine regimens in the relapsed setting. This study investigated outcomes of 108 adult patients with AML in the upfront and relapsed setting treated with a 10-day decitabine regimen. In the upfront group, the overall response rate (ORR, CR + CRi) was 36.1% and the median overall survival (OS) was 6.6 months, while the relapsed/refractory group had an ORR of 25% with an OS of 4.8 months. When analyzed with respect to cytogenetics, the upfront group featured an ORR of 28.1% with an OS of 9.4 months in the intermediate cytogenetic cohort compared to a 40.5% ORR and an OS of 5.4 months in the unfavorable cytogenetic cohort. An analysis of the relapsed/refractory group demonstrated an ORR of 26.3% with an OS of 7.9 months for intermediate cytogenetics versus 25.0% with an OS of 1.8 months in the unfavorable cohort. While these response rates are similar to previously published data, the median OS appears shorter.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Decitabine/administration & dosage ; Disease-Free Survival ; Female ; Humans ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/mortality ; Male ; Middle Aged ; Survival Rate ; Time Factors
Chemical Substances	Decitabine (776B62CQ27)
Language	English
Publishing date	2021-02-12
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	752396-8
ISSN	1873-5835 ; 0145-2126
ISSN (online)	1873-5835
ISSN	0145-2126
DOI	10.1016/j.leukres.2021.106524
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Article ; Online: Re-induction therapy in adult patients with acute myeloid leukemia with ≤20 % blasts: A retrospective cohort study.

Kannan, Kavya K / Vellanki, Paz / Isom, Scott / Tawfik, Bernard / Winter, Allison / Klepin, Heidi D / Ellis, Leslie R / Bhave, Rupali Roy / Howard, Dianna / Manuel, Megan / Dralle, Sarah / Lyerly, Susan / Powell, Bayard L / Pardee, Timothy S

Leukemia research

2021 Volume 111, Page(s) 106731

MeSH term(s)	Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Blast Crisis/drug therapy ; Blast Crisis/pathology ; Female ; Follow-Up Studies ; Humans ; Induction Chemotherapy/methods ; Induction Chemotherapy/mortality ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/pathology ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Survival Rate
Language	English
Publishing date	2021-10-21
Publishing country	England
Document type	Letter ; Research Support, N.I.H., Extramural
ZDB-ID	752396-8
ISSN	1873-5835 ; 0145-2126
ISSN (online)	1873-5835
ISSN	0145-2126
DOI	10.1016/j.leukres.2021.106731
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Article ; Online: The prognostic value of standardized phase angle in adults with acute leukemia: A prospective study.

Yates, Samuel J / Lyerly, Susan / Manuel, Megan / Tooze, Janet A / Klepin, Heidi D / Powell, Bayard L / Dralle, Sarah / Uprety, Alok / Pardee, Timothy S

Cancer medicine

2020 Volume 9, Issue 7, Page(s) 2403–2413

Abstract: Standardized phase angle (SPhA) is a tool used to estimate body composition and cell membrane integrity. Standardized phase angle has been shown to predict survival in solid malignancies and hematopoietic stem cell transplant patients. We investigated ... ...

Abstract	Standardized phase angle (SPhA) is a tool used to estimate body composition and cell membrane integrity. Standardized phase angle has been shown to predict survival in solid malignancies and hematopoietic stem cell transplant patients. We investigated the predictive value of SPhA on 60-day mortality, overall survival (OS), and length of hospital stay (LHS) for adults with acute myelogenous and lymphoblastic leukemia (AML and ALL). Consecutive patients ≥18 years with newly diagnosed acute leukemia receiving intensive chemotherapy were enrolled. Phase angle measurements were taken on day 1 of therapy for all patients and on the day of nadir marrow for AML patients. Measurements were standardized by BMI, gender, and age to calculate the SPhA. The difference between SPhA at nadir bone marrow compared to day 1 of induction was used to calculate change in SPhA. A cutoff of 25th percentile was used to dichotomize baseline SPhA. Among 100 patients, 88% were AML, 56% were female, and mean age was 59 years. Though not statistically significant, OS by Kaplan-Meier analysis was shorter for those below the 25th percentile SPhA compared to those above (median OS: 11.0 months vs 19.5 months; P = .09). Lower baseline SPhA was associated with increased incidence of 60-day mortality in univariable (odds ratio [OR] = 5.25; 1.35, 20.44; P = .02) but not multivariable analysis (OR = 3.12; 0.67, 14.48; P = .15) adjusted for age, creatinine, and cytogenetics. Increased change in SPhA was associated with worse OS (hazard ratio = 1.15; 1.00,1.33; P = .05) in multivariable analysis. Standardized phase angle is a rapid, noninvasive, and objective measure that may be used to inform risk stratification.
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Body Composition ; Bone Marrow/pathology ; Cell Membrane/pathology ; Combined Modality Therapy ; Female ; Follow-Up Studies ; Hematopoietic Stem Cell Transplantation/mortality ; Humans ; Leukemia, Myeloid, Acute/pathology ; Leukemia, Myeloid, Acute/therapy ; Male ; Middle Aged ; Prognosis ; Prospective Studies ; Survival Rate
Language	English
Publishing date	2020-02-12
Publishing country	United States
Document type	Journal Article
ISSN	2045-7634
ISSN (online)	2045-7634
DOI	10.1002/cam4.2835
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Article ; Online: A Phase I Study of CPI-613 in Combination with High-Dose Cytarabine and Mitoxantrone for Relapsed or Refractory Acute Myeloid Leukemia.

Pardee, Timothy S / Anderson, Rebecca G / Pladna, Kristin M / Isom, Scott / Ghiraldeli, Lais P / Miller, Lance D / Chou, Jeff W / Jin, Guangxu / Zhang, Wei / Ellis, Leslie R / Berenzon, Dmitriy / Howard, Dianna S / Hurd, David D / Manuel, Megan / Dralle, Sarah / Lyerly, Susan / Powell, Bayard L

Clinical cancer research : an official journal of the American Association for Cancer Research

2018 Volume 24, Issue 9, Page(s) 2060–2073

Abstract: Purpose: ...

Abstract	Purpose:
MeSH term(s)	Adult ; Aged ; Animals ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Biomarkers ; Biopsy ; Bone Marrow/pathology ; Caprylates/administration & dosage ; Cell Line ; Cell Respiration/drug effects ; Cytarabine/administration & dosage ; Drug Resistance, Neoplasm ; Female ; Humans ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/metabolism ; Leukemia, Myeloid, Acute/mortality ; Leukemia, Myeloid, Acute/pathology ; Male ; Mice ; Middle Aged ; Mitochondria/drug effects ; Mitochondria/genetics ; Mitochondria/metabolism ; Mitoxantrone/administration & dosage ; Neoplasm Grading ; Neoplasm Staging ; Oxygen Consumption/drug effects ; Recurrence ; Retreatment ; Sulfides/administration & dosage ; Treatment Outcome ; Young Adult
Chemical Substances	Biomarkers ; Caprylates ; Sulfides ; Cytarabine (04079A1RDZ) ; Mitoxantrone (BZ114NVM5P) ; devimistat (E76113IR49)
Language	English
Publishing date	2018-02-06
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-17-2282
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Article ; Online: High dose cytarabine, mitoxantrone and l-asparaginase (HAMA) salvage for relapsed or refractory acute myeloid leukemia (AML) in the elderly.

Ahmed, Tamjeed / Holwerda, Scott / Klepin, Heidi D / Isom, Scott / Ellis, Leslie R / Lyerly, Susan / Manuel, Megan / Dralle, Sarah / Berenzon, Dmitriy / Powell, Bayard L / Pardee, Timothy S

Leukemia research

2015 Volume 39, Issue 9, Page(s) 945–949

Abstract: Acute myeloid leukemia (AML) is an aggressive malignancy that affects older patients. The role of salvage therapy in the elderly is controversial and there is little data on efficacy. Outcomes for 94 relapsed or refractory AML patients who received ... ...

Abstract	Acute myeloid leukemia (AML) is an aggressive malignancy that affects older patients. The role of salvage therapy in the elderly is controversial and there is little data on efficacy. Outcomes for 94 relapsed or refractory AML patients who received salvage HAMA therapy were analyzed. Of the 94 patients 66 were ≥60, including 26 patients ≥70, and 28 were <60 years old. Early mortality (30-day) was 14% (4%<60, 18%≥60 years old). Overall, 27% of patients died during hospitalization or were discharged to hospice (11%<60, 33%≥60 years old). CR/CRi was achieved in 41% of patients (61%<60, 33%≥60 years old). Median survival was 6.1 months (15.7<60, 5.2≥60). Patients ≥60 who achieved a CR/CRi had a median survival of 11.7 months. At 12 months 56% of patients <60 were alive versus 24% of patients ≥60. At 24 months these numbers fell to 40% and 2% respectively. In those <60 years old, 50% went on to allogeneic hematopoietic stem cell transplant (HSCT) whereas 14% of patients in the ≥60 cohort did so. In conclusion, HAMA salvage therapy results in a 33% response rate in patients ≥60 years old with acceptable toxicity.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; Asparaginase/administration & dosage ; Cytarabine/administration & dosage ; Drug Administration Schedule ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Karyotype ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/genetics ; Leukemia, Myeloid, Acute/mortality ; Leukemia, Myeloid, Acute/pathology ; Male ; Middle Aged ; Mitoxantrone/administration & dosage ; Recurrence ; Remission Induction ; Retrospective Studies ; Salvage Therapy/methods ; Survival Analysis ; Transplantation, Homologous ; Treatment Outcome
Chemical Substances	Cytarabine (04079A1RDZ) ; Mitoxantrone (BZ114NVM5P) ; Asparaginase (EC 3.5.1.1)
Language	English
Publishing date	2015-09
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	752396-8
ISSN	1873-5835 ; 0145-2126
ISSN (online)	1873-5835
ISSN	0145-2126
DOI	10.1016/j.leukres.2015.05.010
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Article ; Online: Efficacy of the hypomethylating agents as frontline, salvage, or consolidation therapy in adults with acute myeloid leukemia (AML).

Tawfik, Bernard / Sliesoraitis, Sarunas / Lyerly, Susan / Klepin, Heidi D / Lawrence, Julia / Isom, Scott / Ellis, Leslie R / Manuel, Megan / Dralle, Sarah / Berenzon, Dmitriy / Powell, Bayard L / Pardee, Timothy

Annals of hematology

2013 Volume 93, Issue 1, Page(s) 47–55

Abstract: The hypomethylating agents (HAs), azacitidine and decitabine, have emerged as an alternative to initial and salvage therapy in patients with acute myeloid leukemia (AML). Little is known about how AML responds to hypomethylating agents after standard ... ...

Abstract	The hypomethylating agents (HAs), azacitidine and decitabine, have emerged as an alternative to initial and salvage therapy in patients with acute myeloid leukemia (AML). Little is known about how AML responds to hypomethylating agents after standard therapy, and the activity of these agents in a real-world setting is not well studied. We retrospectively examined data for 75 consecutive AML patients at Wake Forest from 2002 to 2011 treated with HAs either as first-line (n = 34), salvage (n = 28), or consolidation (n = 13) therapy. We collected data on age, gender, race, Charlson comorbidity index (CCI), cytogenetics, type of treatment, complete remission (CR), complete remission with incomplete count recovery (CRi), and survival. Statistical analysis was performed using Kaplan-Meier estimates and Cox proportional hazards models. Frontline response rate (CR + CRi) was 26.5 %, and median overall survival (OS) was 3.4 months (95 % CI 1.3-7.4), with 18 % alive at 1 year. In the salvage cohort, the response rate was significantly lower compared to frontline (3.6 versus 26.5 %, p = 0.017). Despite the reduced response, OS from time of HA treatment was longer than frontline at 8.2 months (CI 4.8-10.3). In the consolidation cohort, OS was 13.8 months (CI 8.0-21.6) with one patient in remission more than 30 months from diagnosis. These data suggest that prior cytotoxic therapy decreases marrow response rates to HAs but not survival. Furthermore, use of hypomethylating agents for consolidation resulted in a median overall survival over 1 year in a cohort of older patients. This suggests that hypomethylating agents have activity in all phases of AML treatment.
MeSH term(s)	Age Factors ; Aged ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Azacitidine/administration & dosage ; Azacitidine/analogs & derivatives ; Azacitidine/pharmacology ; Comorbidity ; Consolidation Chemotherapy ; DNA (Cytosine-5-)-Methyltransferases/antagonists & inhibitors ; DNA Damage ; DNA Methylation/drug effects ; DNA, Neoplasm/drug effects ; Decitabine ; Drug Evaluation ; Female ; Humans ; Kaplan-Meier Estimate ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/metabolism ; Male ; Middle Aged ; Neoplasm Proteins/antagonists & inhibitors ; Proportional Hazards Models ; Remission Induction ; Retrospective Studies ; Salvage Therapy ; Survival Rate
Chemical Substances	DNA, Neoplasm ; Neoplasm Proteins ; Decitabine (776B62CQ27) ; DNA (Cytosine-5-)-Methyltransferases (EC 2.1.1.37) ; Azacitidine (M801H13NRU)
Language	English
Publishing date	2013-10-23
Publishing country	Germany
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1064950-5
ISSN	1432-0584 ; 0939-5555 ; 0945-8077
ISSN (online)	1432-0584
ISSN	0939-5555 ; 0945-8077
DOI	10.1007/s00277-013-1940-9
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Article ; Online: A phase I study of the first-in-class antimitochondrial metabolism agent, CPI-613, in patients with advanced hematologic malignancies.

Pardee, Timothy S / Lee, King / Luddy, John / Maturo, Claudia / Rodriguez, Robert / Isom, Scott / Miller, Lance D / Stadelman, Kristin M / Levitan, Denise / Hurd, David / Ellis, Leslie R / Harrelson, Robin / Manuel, Megan / Dralle, Sarah / Lyerly, Susan / Powell, Bayard L

Clinical cancer research : an official journal of the American Association for Cancer Research

2014 Volume 20, Issue 20, Page(s) 5255–5264

Abstract: Purpose: The lipoate derivative CPI-613 is a first-in-class agent that targets mitochondrial metabolism. This study determined the effects of CPI-613 on mitochondrial function and defined the MTD, pharmacokinetics, and safety in patients with relapsed ... ...

Abstract	Purpose: The lipoate derivative CPI-613 is a first-in-class agent that targets mitochondrial metabolism. This study determined the effects of CPI-613 on mitochondrial function and defined the MTD, pharmacokinetics, and safety in patients with relapsed or refractory hematologic malignancies. Experimental design: Human leukemia cell lines were exposed to CPI-613 and mitochondrial function was assayed. A phase I trial was conducted in which CPI-613 was given as a 2-hour infusion on days 1 and 4 for 3 weeks every 28 days. Results: CPI-613 inhibited mitochondrial respiration of human leukemia cells consistent with the proposed mechanism of action. In the phase I trial, 26 patients were enrolled. CPI-613 was well tolerated with no marrow suppression observed. When the infusion time was shortened to 1 hour, renal failure occurred in 2 patients. At 3,780 mg/m(2), there were two dose-limiting toxicities (DLT). At a dose of 2,940 mg/m(2) over 2 hours, no DLTs were observed, establishing this as the MTD. Renal failure occurred in a total of 4 patients and resolved in all but 1, who chose hospice care. CPI-613 has a triphasic elimination with an alpha half-life of approximately 1.34 hours. Of the 21 evaluable, heavily pretreated patients, 4 achieved an objective response and 2 achieved prolonged stabilization of disease for a clinical benefit rate of 29%. Following drug exposure, gene expression profiles of peripheral blood mononuclear cells from responders demonstrated immune activation. Conclusion: CPI-613 inhibits mitochondrial function and demonstrates activity in a heavily pretreated cohort of patients.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Caprylates/pharmacology ; Caprylates/therapeutic use ; Cell Line, Tumor ; Drug Administration Schedule ; Female ; Hematologic Neoplasms/diagnosis ; Hematologic Neoplasms/drug therapy ; Hematologic Neoplasms/metabolism ; Hematologic Neoplasms/mortality ; Hematologic Neoplasms/pathology ; Humans ; Leukemia/drug therapy ; Leukemia/metabolism ; Leukemia/pathology ; Male ; Middle Aged ; Mitochondria/drug effects ; Mitochondria/metabolism ; Neoplasm Staging ; Positron-Emission Tomography ; Sulfides/pharmacology ; Sulfides/therapeutic use ; Tomography, X-Ray Computed ; Treatment Outcome ; Young Adult
Chemical Substances	Antineoplastic Agents ; CPI 613 ; Caprylates ; Sulfides
Language	English
Publishing date	2014-08-27
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-14-1019
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