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A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission


Phase 2
50 Years
N/A
Not Enrolling
Both
Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b)

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Trial Information

A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission


PRIMARY OBJECTIVES:

I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in
first complete remission treated with cilengitide as maintenance therapy.

SECONDARY OBJECTIVES:

I. Determine overall survival of patients treated with this drug. II. Determine the safety
and toxicity of this drug in these patients. III. Determine the biological activity of this
drug in cells from these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.

Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4
weeks.

In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable
toxicity.


Inclusion Criteria:



- Diagnosis of acute myeloid leukemia (AML)

- In first complete remission after at least 1 course of induction chemotherapy AND 1-2
courses of consolidation chemotherapy for newly diagnosed AML, as defined by the
following:

- No evidence of disease in bone marrow

- Recovery of peripheral blood counts

- Platelet count > 100,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Must be able to start study medication within 60 days from the start of the last
consolidation therapy

- Must not have a suitable donor, refused, or ineligible for hematopoietic stem call
transplantation

- None of the following AML subtypes or chromosomal translocations:

- Acute promyelocytic leukemia

- t(8;21)

- t(16;16)

- inv(16)

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- See Disease Characteristics

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT ≤ 2.5 times ULN

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance > 60mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No prior investigational agents specifically designated as an antiangiogenic agent

- No concurrent prophylactic hematopoietic colony-stimulating factors

- See Disease Characteristics

- Recovered from prior consolidation chemotherapy

- No other concurrent anticancer therapies

- No other concurrent investigational cytotoxic agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Description:

Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.

Outcome Time Frame:

From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years

Safety Issue:

No

Principal Investigator

Srdan Verstovsek

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02621

NCT ID:

NCT00089388

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Adult Acute Basophilic Leukemia
  • Adult Acute Eosinophilic Leukemia
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Basophilic, Acute
  • Leukemia, Eosinophilic, Acute
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Hypereosinophilic Syndrome

Name

Location
M D Anderson Cancer Center Houston, Texas  77030