LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)

NCT01041040 | Completed Phase 4 DMC

• 1 other identifier: PETHEMA-LAM07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients with acute myeloid leukemia (AML).

Conditions

Acute Myeloblastic Leukemia

Keywords

Acute Myeloblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• To provide prognosis stratification of AML patients at the end of the induction treatment, based on minimal residual disease (MRD), cytogenetics and molecular findings.

• To evaluate the efficacy and safety of a post-remission therapy strategy adapted to the prognosis of the patients, which optimizes the currently available treatment options and includes GO

Secondary Outcomes (1)

• To analyze the different prognosis factors in AML, including the karyotype and the molecular findings at diagnosis and the MRD level at the end of the induction.

Interventions

gemtuzumab DRUG

gemtuzumab ozogamicin (GO) during consolidation for patients with acute myeloid leukemia (AML)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For intensive chemotherapy:
• Patients with the novo AML or secondary to MDS or previous treatment, regardless of age.
• Signed written informed consent.
• ECOG ≤ 2. If ECOG is greater than 2 due to AML, the patient can be included in the study.
• LVEF \> 40 % measured by means of echocardiography.
• If background of respiratory disease (not related to the AML), risk factors or clinical criteria for COPD, the values of functional tests, including DLCO, should be greater than 50% of the expected.
• Bilirubin, alkaline phosphatase and ALT \< of 3 fold the upper normal value, providing that it is not due to the disease that motivates the treatment (AML).
• Serum creatinine \< 2,5 mg/dL providing that it is not due to the disease that motivates the treatment (AML).
• In fertile aged women, negative pregnancy test and use of contraception methods are required.

You may not qualify if:

• Criteria for GO administration in patient candidates for intensive chemotherapy
• Same criteria for intensive chemotherapy, including the following specifications:
• CD33 positive (more than 5 % of the leukemic population)
• In patients who are going to receive GO in two cycles, the second one will be only administrated if the toxicity due to the first cycle is recovered.
• Though the GO administered dose is much lower than usual, it is recommended a period of two months between GO administration and hematopoietic stem cell transplantation (HSCT).
• Criteria for the modification of high dose ARA-C
• The dose of Ara-C in cycles containing HiDAC should be reduced in the following cases:
• The hematopoietic recovery in the previous cycle has been longer than 28 days.
• Presence in the previous cycles of a confluent maculopapular rash or drug-induced shedding.
• More than 4 episodes of watery diarrhea per day.
• Increase of 4 fold the previous normal value of aminotransferases or alkaline phosphatase in any of the cycles.
• Total bilirubin greater than 3 mg/dL in any of the cycles.
• Treatment with HiDAC will be definitively suspended (even that included in the BEA conditioning) when previous toxicity include severe cerebellar ataxia, confusion or another sign of central nervous toxicity that has not another clear explanation.
• Patients with blastic crisis of a chronic myeloid leukemia or other myeloproliferative syndromes evolving to acute leukemia.
• Patients with AML in relapse.

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (1)

Hoapital La Fe

Valencia, Valencia, Spain

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sanz Miguel Angel, Dr

  PETHEMA Foundation

  STUDY CHAIR

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: December 28, 2009
• First Posted: December 30, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

ES (1)