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Single Agent Arsenic Trioxide in the Treatment of Newly Diagnosed Acute Promyelocytic Leukemia (IAPLSG04)

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ClinicalTrials.gov Identifier: NCT00517712
Recruitment Status : Unknown
Verified August 2007 by Christian Medical College, Vellore, India.
Recruitment status was:  Recruiting
First Posted : August 17, 2007
Last Update Posted : August 17, 2007
Ministry of Science and Technology, India
Information provided by:
Christian Medical College, Vellore, India

Brief Summary:
There is very limited data on the use of arsenic trioxide in newly diagnosed patients with acute promyelocytic leukemia. The use of arsenic trioxide was limited to relapsed patients mainly because of the superior efficacy of ATRA as primary therapy for newly diagnosed APML. Though the early study by Niu et al showed 72% remission rates in 11 newly diagnosed patients, the role of arsenic trioxide as primary therapy was limited by the hepatic toxicity seen in this study. Studies from our centre have shown remission rates of 70-75% in newly diagnosed patients with acute promyelocytic leukemia. There was no major toxicity seen related to the administration of arsenic trioxide. Follow up data on these patients continue to show long term remission rates above 70%. These remission rates are similar to the data available in patients with acute promyelocytic leukemia treated with ATRA. Lu et al studied 19 patients treated with oral arsenic (Tetra-arsenic tetra-sulfide) wherein 84% achieved hematological remission with disease free survival of 76% at 3 years. Studies from other groups using arsenic trioxide alone or in combination with ATRA have shown similar remission rates. Arsenic trioxide as primary therapy for patients with newly diagnosed acute promyelocytic leukemia is a very attractive treatment option for developing countries mainly because of the low cost involved along with the favorable toxicity profile. However long term remission data is still not available and the ideal course and duration of treatment still needs to be defined. This multi-center study aims to further clarify the efficacy of this agent in the treatment of newly diagnosed cases of acute promyelocytic leukemia and to study the optimal maintenance regimen.

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Drug: Single agent arsenic trioxide Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Remission With Arsenic Trioxide in Acute Promyelocytic Leukemia: Indian APL Study Group - IAPLSG
Study Start Date : June 2004
Estimated Study Completion Date : July 2009

Arm Intervention/treatment
Active Comparator: A
Duration of maintenance therapy with single agent ATO of 12 months
Drug: Single agent arsenic trioxide
duration of maintenance therapy, 6 months versus 12 months
Active Comparator: B
Duration of maintenance therapy with single agent ATO for 6 months
Drug: Single agent arsenic trioxide
duration of maintenance therapy, 6 months versus 12 months

Primary Outcome Measures :
  1. Measure complete hematological remission rate [ Time Frame: 60 days ]
  2. Measure complete molecular remission rate [ Time Frame: 3 months ]
  3. Measure duration of response [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Document early and late toxicities [ Time Frame: 5 years ]
  2. Measure relapse rates [ Time Frame: 5 years ]
  3. Measure treatment related mortality [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients included in this trial should have been diagnosed to have Acute Promyelocytic Leukemia morphologically on FAB criteria. This is sufficient to initiate therapy with arsenic tri-oxide but this diagnosis has to be confirmed using either Fluorescent in situ hybridization (FISH) for t(15;17) or reverse transcriptase polymerase chain reaction assay (RT-PCR) for PML-RARalpha transcripts within 7 days of inclusion into the study.
  • All these patients would have in the absence of this study received only palliative therapy due to the lack of resources to support standard chemotherapy.

Exclusion Criteria:

  • Women who are pregnant
  • Patients with acute promyelocytic leukemia who are found on standard karyotyping/ FISH/RTPCR to have t(11;17) or t(5;17).

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): NCT00517712

Contact: Vikram Mathews, MD 91-416-2282891 vikram@cmcvellore.ac.in
Contact: Mammen Chandy, MD 91-416-2282169 mammen@cmcvellore.ac.in

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Principal Investigator: P P Bapsy, MD         
St. Johns Hospital Recruiting
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Contact: Cecil Ross, MD    91-80-22065000    ross@satyam.net.in   
Principal Investigator: Cecil Ross, MD         
Regional Cancer Center Recruiting
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Prince Aly Khan Hospital Not yet recruiting
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Contact: Tapan Saikia, MD    91-22-23777800    tsaikias@yahoo.co.in   
Principal Investigator: Tapan Saikia, MD         
KEM Hospital Recruiting
Mumbai, Maharastra, India, 400012
Contact: Farah Jijina, MD    91-22-22872904    f_jijina@hotmail.com   
Principal Investigator: Farrah Jijina, MD         
Tata Memorial Hospital Recruiting
Mumbai, Maharastra, India, 400012
Contact: Reena Nair, MD    91-22-4146750    reenanair@email.com   
Principal Investigator: Purvish Parikh, MD         
Sahyadri Speciality Hospital Recruiting
Pune, Maharastra, India
Contact: Shashi Apte, MD    91-20-25403040    sashi@pn3.vsnl.net.in   
Principal Investigator: Shashi Apte, MD         
Netaji Subhash Chandra Bose Cancer Research Institute Recruiting
Kolkata, West Bengal, India, 700016
Contact: Ashis Mukherjee, MD    91-33-22291049    hmcwt@dataone.in   
Principal Investigator: Ashish Mukherjee, MD         
Institute Rotary Cancer Hospital Recruiting
New Delhi, India, 110029
Contact: Atul Sharma, MD    91-11-26589490    atul1@hotmail.com   
Principal Investigator: Vinod Kochupillai, MD         
Sponsors and Collaborators
Christian Medical College, Vellore, India
Ministry of Science and Technology, India
Principal Investigator: Mammen Chandy, MD Christian Medical College, Vellore, India


ClinicalTrials.gov Identifier: NCT00517712     History of Changes
Other Study ID Numbers: IAPLSG2004
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: August 2007

Keywords provided by Christian Medical College, Vellore, India:
Acute promyelocytic leukemia
Arsenic trioxide
Molecular remission
Toxicity profile
Maintenance therapy

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic trioxide
Antineoplastic Agents