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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Christian Medical College, Vellore, India.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Ministry of Science and Technology, India
Information provided by:
Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier:
NCT00517712
First received: August 16, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose
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 Intervention Phase
Acute Promyelocytic Leukemia
Drug: Single agent arsenic trioxide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Molecular Remission With Arsenic Trioxide in Acute Promyelocytic Leukemia: Indian APL Study Group - IAPLSG

Resource links provided by NLM:


Further study details as provided by Christian Medical College, Vellore, India:

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

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

Estimated Enrollment: 400
Study Start Date: June 2004
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517712

Locations
India
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India, 560029
St. Johns Hospital
Bangalore, Karnataka, India, 560034
Regional Cancer Center
Trivandrum, Kerala, India, 695011
Prince Aly Khan Hospital
Mumbai, Maharastra, India, 400010
KEM Hospital
Mumbai, Maharastra, India, 400012
Tata Memorial Hospital
Mumbai, Maharastra, India, 400012
Sahyadri Speciality Hospital
Pune, Maharastra, India
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, India, 700016
Institute Rotary Cancer Hospital
New Delhi, India, 110029
Sponsors and Collaborators
Christian Medical College, Vellore, India
Ministry of Science and Technology, India
Investigators
Principal Investigator: Mammen Chandy, MD Christian Medical College, Vellore, India
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00517712     History of Changes
Other Study ID Numbers: IAPLSG2004  BT/PR4460/Med/14/531/2003 
Study First Received: August 16, 2007
Last Updated: August 16, 2007
Health Authority: India: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on December 05, 2016