Know Cancer

or
forgot password

An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)


OBJECTIVES:

Primary

- To determine the complete response rate in older patients with relapsed or refractory
acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.

Secondary

- To determine the tolerability and safety of this regimen.

- To determine the duration of response.

- To determine the duration of survival.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and
temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2
courses in the absence of disease progression or unacceptable toxicity.

- Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with
incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8
of each month. Treatment continues for 12 months in the absence of disease progression
or unacceptable toxicity.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:

- At least 20% of blasts in the bone marrow

- AML in first relapse OR refractory to no more than one prior combination
chemotherapy induction regimen

- No acute promyelocytic leukemia

- No blast transformation of chronic myeloid leukemia or other myeloproliferative
disorders

- No active CNS leukemia

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Life expectancy ≥ 4 weeks

- Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)*

- AST and ALT ≤ 2.5 times ULN*

- Serum creatinine ≤ 1.0 mg/dL* OR estimated glomerular filtration rate > 60 mL/min

- No active uncontrolled systemic infection

- No concurrent active malignancy

- No HIV positivity

- No severe concurrent medical condition or psychiatric disorder that would preclude
study participation NOTE: *Unless due to organ leukemic involvement

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 2 weeks since prior myelosuppressive chemotherapy

- At least 48 hours since prior hydroxyurea

- No prior clofarabine or temsirolimus

- No prior allogeneic stem cell transplantation

- No investigational drug within the past 30 days

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Time Frame:

At 2 years from study entry

Safety Issue:

No

Principal Investigator

Sergio Amadori, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ospedale Sant' Eugenio

Authority:

Italy: Ethics Committee

Study ID:

AML1107

NCT ID:

NCT00775593

Start Date:

December 2008

Completion Date:

June 2012

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute basophilic leukemia
  • adult acute eosinophilic leukemia
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • 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 with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location