Main info

Identifier:

HO30 AML

Sponsor:

HOVON

Included patients:

82

Active sites:

18

(of 18)

Title:

Addition of Cyclosporin A to the Combination of Mitoxantrone and Etoposide to Overcome Resistance to Chemotherapy in Refractory Acute Myeloid Leukemia: A Randomized Phase II Study.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Newly diagnosed adult AML patients in sufficiently good condition who did not attain CR after standardized chemotherapy courses with idarubicin plus Ara-C and AMSA plus Ara-C respectively (HOVON 29).
• Adult patients with AML in first or subsequent relapse after a previously attained CR.

Exclusion Criteria:

• AML patients not fulfilling the above inclusion criteria.
• Patients with myelodysplasia.
• Severe cardiac, pulmonary, neurologic or metabolic disease.
• Suboptimal kidney function.
• Uncontrolled hypertension.
• Liver function abnormalities.
• Severe infection not controllable with adequate antimicrobial therapy.
• Serological positivity for HIV.
• Concomitant malignancy except non-melanomatous skin tumors and carcinoma in situ of the cervix uteri.
• Pregnancy.
• Known intolerance for one of the study drugs.
• Refusal of the patient.

Participating Sites

= Active hospitals

= Inactive hospitals