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Trial record 26 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

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

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ClinicalTrials.gov Identifier: NCT01794702
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : May 10, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia.

The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied.

Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die.

Clofarabine is designed to interfere with the growth and development of cancer cells.

Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Decitabine Drug: Idarubicin Drug: Cytarabine Drug: Clofarabine Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Sequential Assignment
Intervention Model Description:

Starting with Dose level 1, the participants were enrolled by cohort of 3. Once the DLT assessment is completed, another cohort of 3 patients will be enrolled. If at any time, we see more than 30% patients experiencing DLT, we will de-escalate to dose level (-1).

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)

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia
Actual Study Start Date : February 20, 2013
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : January 11, 2018


Arm Intervention/treatment
Experimental: Clofarabine + Cytarabine + Decitabine + Idarubicin

Phase I - Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)

Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour daily (number of days selected based on Phase I portion).

Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)

Drug: Decitabine
Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)
Other Name: Dacogen

Drug: Idarubicin
Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)
Other Name: Idamycin

Drug: Cytarabine
Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)
Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride

Drug: Clofarabine

Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9)

Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion).

Other Names:
  • Clofarex
  • Clolar




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Clofarabine [ Time Frame: After second, 33 day cycle ]
    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).

  2. Number of Participants With a Response [ Time Frame: 56 days ]
    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.


Secondary Outcome Measures :
  1. To Determine the Disease-free Survival (DFS). [ Time Frame: Up to 2 years after participants off study date ]
    Time from date of treatment start until the date of first objective documentation of return of disease.

  2. Overall Survival [ Time Frame: Up to 2 years after participants off study date ]
    Time from date of treatment start until date of death due to any cause or last Follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign an IRB-approved informed consent document.
  2. Age >/= 18 years and <65 years.
  3. Diagnosis of AML [other than acute promyelocytic leukemia] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed
  4. ECOG performance status of </=2 at study entry.
  5. Organ function as defined below (unless due to leukemia):Serum creatinine </= 3 mg/dL;Total bilirubin </= 2.5 mg/dL; ALT (SGPT) </= 3 x ULN or </= 5 x ULN if related to disease
  6. Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)
  7. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

  1. Breast feeding women
  2. Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
  3. Patients with active secondary malignancy will not be eligible unless approved by the PI.
  4. NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794702


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Nitin Jain, MBBS M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01794702     History of Changes
Other Study ID Numbers: 2012-1064
NCI-2013-00548 ( Registry Identifier: NCI CTRP )
First Posted: February 20, 2013    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Acute Leukemia
Leukemia
Acute myelogenous leukemia
AML
Acute lymphoblastic leukemia
ALL
Maximum Tolerated Dose
MTD
Response Rate
Decitabine
Dacogen
Idarubicin
Idamycin
Cytarabine
Ara-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Clofarabine
Idarubicin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors