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Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.


Phase 1/Phase 2
15 Years
N/A
Not Enrolling
Both
Acute Lymphocytic Leukemia

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Trial Information

Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.


All patients receive Alemtuzumab in 3 successive phases:

Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for
tolerance.

Phase B: 30mg 3 times a week for 12 to 18 administrations until response or
progression/failure has been documented.

Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2
months.


Inclusion Criteria:



- Patients older than 15 years

- Refractory ALL

- ALL in relapse post chemotherapy or post transplant

- ALL blast cells expressing CD 52 antigen at any time during the evolution of the
disease.

- Signed informed consent

- Patients under social security coverage

- Anti conceptional tablets in pre menopausal women.

Exclusion Criteria:

- Children below 15 years of age or aged 15

- Blast cells not expressing CD52 antigen (at all evaluations)

- HIV positivity

- ECOG Score 3 and 4

- Hypersensitivity to Alemtuzumab.

- Pregnancy or breast feeding.

- Other malignant disease in addition to ALL.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Partial and complete remission, overall response rates

Outcome Time Frame:

At 2 years

Safety Issue:

Yes

Principal Investigator

Norbert Claude GORIN, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - H├┤pitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P051003

NCT ID:

NCT00773149

Start Date:

October 2006

Completion Date:

July 2011

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Adult Acute Lymphocytic Leukemia
  • Alemtuzumab
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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