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Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030355
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : March 22, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: homoharringtonine Procedure: chemotherapy Phase 1 Phase 2

Detailed Description:


  • Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia.
  • Determine the antileukemic efficacy of this drug in these patients.

OUTLINE: Patients receive remission induction therapy comprising homoharringtonine (HH) IV continuously on days 1-14. Courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission (CR) is achieved or the patient fails to respond after 3 courses.

Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH IV continuously on days 1-7. Maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: A Phase I/II Open-Label Study Of The Intravenous Administration Of Homoharringtonine (CGX-635) Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia

Primary Outcome Measures :
  1. Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events
  2. Efficacy by response to treatment

Secondary Outcome Measures :
  1. Pharmacokinetics
  2. Duration of treatment response
  3. Survival
  4. Induction mortality
  5. Hospitalizations

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction
  • Refractory to tretinoin, anthracyclines, and arsenic-based therapy (including arsenic trioxide) and for which no other alternative therapy of higher priority is appropriate



  • 12 and over

Performance status:

  • Zubrod 0-3

Life expectancy:

  • More than 4 weeks


  • See Disease Characteristics


  • Bilirubin no greater than 2.0 mg/dL
  • ALT no greater than 3 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • No New York Heart Association class III or IV heart disease
  • No active ischemia
  • No other uncontrolled cardiac condition (e.g., angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure)
  • No myocardial infarction within the past 12 weeks


  • No other concurrent illness that would preclude study
  • No other active malignancy
  • No uncontrolled active infection
  • No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia
  • No medical or psychiatric condition that would preclude informed consent or study therapy
  • HIV negative
  • HTLV-I and HTLV-II negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior or concurrent leukapheresis allowed


  • See Disease Characteristics
  • At least 15 days since prior systemic chemotherapy unless leukemia progression necessitates early therapy
  • No other concurrent systemic chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • Recovered from prior therapy
  • At least 15 days since other prior antileukemic therapy unless leukemia progression necessitates early therapy
  • No other concurrent antileukemic therapy

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 identifier (NCT number): NCT00030355

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United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center

Layout table for additonal information Identifier: NCT00030355    
Other Study ID Numbers: CDR0000069158
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: September 2007
Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
adult acute promyelocytic leukemia (M3)
childhood acute promyelocytic leukemia (M3)
adult acute myeloid leukemia with t(15;17)(q22;q12)
Additional relevant MeSH terms:
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Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action