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)

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01041040
First received: December 28, 2009
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Acute Myeloblastic Leukemia
Drug: gemtuzumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PETHEMA LAM07: 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)

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To provide prognosis stratification of AML patients at the end of the induction treatment, based on minimal residual disease (MRD), cytogenetics and molecular findings. [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2007
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gemtuzumab
    gemtuzumab ozogamicin (GO) during consolidation for patients with acute myeloid leukemia (AML)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For intensive chemotherapy:

  1. Patients with the novo AML or secondary to MDS or previous treatment, regardless of age.
  2. Signed written informed consent.
  3. ECOG ≤ 2. If ECOG is greater than 2 due to AML, the patient can be included in the study.
  4. LVEF > 40 % measured by means of echocardiography.
  5. 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.
  6. 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).
  7. Serum creatinine < 2,5 mg/dL providing that it is not due to the disease that motivates the treatment (AML).
  8. In fertile aged women, negative pregnancy test and use of contraception methods are required.

Any patient who does not meet the inclusion and exclusion criteria for treatment with intensive chemotherapy can be evaluated individually when considering that could still obtain benefit from this treatment considering that could still obtain benefit from this treatment.

Criteria for GO administration in patient candidates for intensive chemotherapy

Same criteria for intensive chemotherapy, including the following specifications:

  1. CD33 positive (more than 5 % of the leukemic population)
  2. Exclusion for treatment with GO in cases of serious hepatic disease not due to AML.
  3. 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.
  4. 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:

  1. The hematopoietic recovery in the previous cycle has been longer than 28 days.
  2. Presence in the previous cycles of a confluent maculopapular rash or drug-induced shedding.
  3. More than 4 episodes of watery diarrhea per day.
  4. Increase of 4 fold the previous normal value of aminotransferases or alkaline phosphatase in any of the cycles.
  5. Total bilirubin greater than 3 mg/dL in any of the cycles.
  6. 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.

Exclusion Criteria:

  1. Patients with blastic crisis of a chronic myeloid leukemia or other myeloproliferative syndromes evolving to acute leukemia.
  2. Patients with AML in relapse.
  3. Acute promyelocytic leukemia (M3 or M3v).
  4. Absence of signed written informed consent.
  5. ECOG ≥ 3 that it is not due to the disease that motivates the treatment (AML).
  6. LVEF < 40 % determined by echocardiography study.
  7. Values of respiratory functional tests, including DLCO, lower than 50% of the expected.
  8. Bilirubin, alkaline phosphatase or GOT > 3 fold the upper normal value, providing that it is not due to the disease that motivates the treatment (AML).
  9. Serum creatinine > of 2.5 mg/dL providing that it is not due to the disease that motivates the treatment (AML).
  10. Positive pregnancy test or not use of effective contraception in fertile aged women.
  11. Previous treatment with antileukemic chemotherapy, except hydroxyurea.
  12. Presence of an active neoplasia different from the AML.
  13. Presence of a serious psychiatric disease.
  14. Positive HIV test.
  15. Any other condition which limits or dissuades from the treatment with intensive chemotherapy, especially with anthracyclines
  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: NCT01041040

Locations
Spain
Hoapital La Fe
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Sanz Miguel Angel, Dr PETHEMA Foundation
  More Information

No publications provided

Responsible Party: Josep Mª Ribera/Executive Secretary, PETHEMA
ClinicalTrials.gov Identifier: NCT01041040     History of Changes
Other Study ID Numbers: PETHEMA-LAM07
Study First Received: December 28, 2009
Last Updated: July 30, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Gemtuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014