Treatment Protocol for Relapsed Acute Promyelocytic Leukemia (APL) With Arsenic

NCT00196768 | Unknown Phase 4

• 1 other identifier: 30052004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia. By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be reached. On average, about 10% of patients still die in the early phase of the treatment and about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the individual kinetics of MRD and to identify patients with an imminent hematological relapse. A standardized treatment for patients with relapsed APL has not yet been established. With arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower concentrations. ATO was also successfully administered before allogeneic and autologous transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe and in the USA. In the present protocol, ATO is given for remission induction:

1. 1.in patients with hematological or molecular first or subsequent relapse of APL and
2. 2.in patients who do not reach a hematological or molecular remission after first line therapy.
3. 3.the eligibility for allogeneic transplantation
4. 4.the eligibility for autologous transplantation
5. 5.the presence or absence of contraindications against intensive chemotherapy
6. 6.the PCR status after induction and during follow up (RT-PCR of PML/RARa, sensitivity 10-4)

Conditions

Relapsed Acute Promyelocytic Leukemia; Refractory Acute Promyelocytic Leukemia

Keywords

relapsed; acute promyelocytic leukemia; arsenic

Outcome Measures

Primary Outcomes (3)

• the rate of hematological remission

• the rate of molecular remission

• the kinetics of the MRD of PML/RARa during and after ATO

Secondary Outcomes (4)

• the side effects of ATO

• percentage of transplantable patients in comparison to the historical results after chemotherapy

• the overall survival

• duration of the hematological and molecular remission

Interventions

Arsenic trioxide DRUG

Trisenox DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in first or subsequent hematological or molecular relapse of APL
• Persistence of a positive PCR or no hematological complete remission (CR) after first line therapy
• No complete hematological remission after first line therapy
• Age over 18 years
• No upper age limit
• Informed consent of the patient

You may not qualify if:

• Absolute QTc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the QT-interval)
• Heart failure New York Health Association grade III and IV
• Renal or hepatic failure World Health Organization grade \>= III
• Pneumonia with hypoxemia
• Uncontrolled sepsis
• Pregnancy and lactation period
• Secondary malignancy, which will have major influence on the prognosis
• Expected noncompliance
• No informed consent of the patient.

Sponsors & Collaborators

• German AML Cooperative Group: lead

Study Sites (1)

Eva Lengfelder, MD, PhD

Mannheim, 68305, Germany

RECRUITING

Related Publications (1)

• Toft P, Olsen HT, Jorgensen HK, Strom T, Nibro HL, Oxlund J, Wian KA, Ytrebo LM, Kroken BA, Chew M. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial. Trials. 2014 Dec 20;15:499. doi: 10.1186/1745-6215-15-499.

  PMID: 25528350 DERIVED

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute; Recurrence

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Eva Lengfelder, MD, PhD

  German AMLCG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Lengfelder, MD, PhD

CONTACT

0049 621 3834110; eva.lengfelder@med3.ma.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Study Completion: December 1, 2010
• Last Updated: October 23, 2007

Record last verified: 2007-10

Locations

DE (1)