NCT00517712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 17, 2007

Status Verified

August 1, 2007

First QC Date

August 16, 2007

Last Update Submit

August 16, 2007

Conditions

Acute Promyelocytic Leukemia

Keywords

Acute promyelocytic leukemiaArsenic trioxideMolecular remissionToxicity profileMaintenance therapy

Outcome Measures

Primary Outcomes (3)

  • Measure complete hematological remission rate

    60 days

  • Measure complete molecular remission rate

    3 months

  • Measure duration of response

    5 years

Secondary Outcomes (3)

  • Document early and late toxicities

    5 years

  • Measure relapse rates

    5 years

  • Measure treatment related mortality

    60 days

Study Arms (2)

A

ACTIVE COMPARATOR

Duration of maintenance therapy with single agent ATO of 12 months

Drug: Single agent arsenic trioxide

B

ACTIVE COMPARATOR

Duration of maintenance therapy with single agent ATO for 6 months

Drug: Single agent arsenic trioxide

Interventions

Single agent arsenic trioxideDRUG

duration of maintenance therapy, 6 months versus 12 months

AB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

NOT YET RECRUITING

St. Johns Hospital

Bangalore, Karnataka, 560034, India

RECRUITING

Regional Cancer Center

Trivandrum, Kerala, 695011, India

RECRUITING

Prince Aly Khan Hospital

Mumbai, Maharashtra, 400010, India

NOT YET RECRUITING

KEM Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Sahyadri Speciality Hospital

Pune, Maharashtra, India

RECRUITING

Institute Rotary Cancer Hospital

New Delhi, New Delhi, 110029, India

RECRUITING

Netaji Subhash Chandra Bose Cancer Research Institute

Kolkata, West Bengal, 700016, India

RECRUITING

Related Publications (7)

  • Mathews V, George B, Lakshmi KM, Viswabandya A, Bajel A, Balasubramanian P, Shaji RV, Srivastava VM, Srivastava A, Chandy M. Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: durable remissions with minimal toxicity. Blood. 2006 Apr 1;107(7):2627-32. doi: 10.1182/blood-2005-08-3532. Epub 2005 Dec 13.

    PMID: 16352810BACKGROUND

  • George B, Mathews V, Poonkuzhali B, Shaji RV, Srivastava A, Chandy M. Treatment of children with newly diagnosed acute promyelocytic leukemia with arsenic trioxide: a single center experience. Leukemia. 2004 Oct;18(10):1587-90. doi: 10.1038/sj.leu.2403480.

    PMID: 15356649BACKGROUND

  • Mathews V, Balasubramanian P, Shaji RV, George B, Chandy M, Srivastava A. Arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: a single center experience. Am J Hematol. 2002 Aug;70(4):292-9. doi: 10.1002/ajh.10138.

    PMID: 12210810BACKGROUND

  • Mathews V, Chandy M, Srivastava A. Arsenic trioxide in the management of acute promyelocytic leukaemia. Natl Med J India. 2001 Jul-Aug;14(4):215-22.

    PMID: 11547528BACKGROUND

  • George B, Mathews L, Balasubramanian P, Shaji RV, Srivastava A, Chandy M. Molecular remission with arsenic trioxide in patients with newly diagnosed acute promyelocytic leukemia. Haematologica. 2004 Oct;89(10):1266-7.

    PMID: 15477216BACKGROUND

  • Mathews V, Desire S, George B, Lakshmi KM, Rao JG, Viswabandya A, Bajel A, Srivastava VM, Srivastava A, Chandy M. Hepatotoxicity profile of single agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia, its impact on clinical outcome and the effect of genetic polymorphisms on the incidence of hepatotoxicity. Leukemia. 2006 May;20(5):881-3. doi: 10.1038/sj.leu.2404165. No abstract available.

    PMID: 16525498BACKGROUND

  • Mathews V, Thomas M, Srivastava VM, George B, Srivastava A, Chandy M. Impact of FLT3 mutations and secondary cytogenetic changes on the outcome of patients with newly diagnosed acute promyelocytic leukemia treated with a single agent arsenic trioxide regimen. Haematologica. 2007 Jul;92(7):994-5. doi: 10.3324/haematol.10802.

    PMID: 17606455BACKGROUND

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mammen Chandy, MD

    Christian Medical College, Vellore, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikram Mathews, MD

CONTACT

91-416-2282891vikram@cmcvellore.ac.in

Mammen Chandy, MD

CONTACT

91-416-2282169mammen@cmcvellore.ac.in

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

June 1, 2004

Study Completion

July 1, 2009

Last Updated

August 17, 2007

Record last verified: 2007-08

Locations

IN(9)