Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remissio

Not Applicable

• Conditions: -C920 Acute myeloblastic leukaemia [AML]; C920; Acute myeloblastic leukaemia [AML]

• Registration Number: PER-058-06
• Lead Sponsor: EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Eligible patients must be in one of the following categories: A) Patients in first complete remission followed by failure of primary induction. B) Patients must have received at least two induction therapy regimens. C) Patients in second or subsequent complete remission (CR2).
2) Patients must be in CR by haematological and bone marrow studies.
3) Patients must have morphological evidence of having AML of one of the following types before entering CR: a) Acute myeloblastic leukemia (MO, M1, M2). b) Acute myelomonocytic leukemia (M4). c) Acute monocytic leukemia (M5). d) Acute erythroleukemia (M6). e) Acute megakaryocytic leukemia (M7). f) Refractory anemia with excess blasts in transformation (RAEB-T)
4) Patients with acute promyelocytic leukemia are not eligible.
5) Patients must register within 60 days of the end of therapy for the current referral.
6) ANC> 1000 / mm3.
7) Platelet count> 100,000 / mm3.
6) Patients who have received consolidation therapy are eligible.
9) Patients who have received an autologous stem cell transplant are eligible.
10) Patients who have not received some form of post-remission therapy are eligible.
11) Patients who have received an allogeneic transplant in the current remission are not eligible.
12) Patients with a history of extramedullary disease are eligible if they are in CR at the time of entering the study and do not require therapy for their extramedullary disease.
13) Patients should not be pregnant or breastfeeding.
14) Potentially pregnant women and sexually active men should be advised to use an effective contraceptive method.
15) Patients should not have known allergy to imidazole, as well as clotrimazole, ketoconazole, miconazole, econazole or terconazole, as they would have an increased risk of allergic reaction to R115777.
16) Patients must be over 18 years of age.
17) Patients must include the following criteria at the time of recruitment: ECOG Status 0-2.

Exclusion Criteria

1) Active cardiac or pulmonary disease.
2) Active kidney disease.
3) Active liver disease.
4) Patients should not be taking an anticonvulsant inducer of liver enzymes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified