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)

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Gemtuzumab

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