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Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy

S

Sheba Medical Center

Status and phase

Unknown
Phase 3

Conditions

Leukemia, Myeloid, Philadelphia-Positive

Treatments

Drug: Pegylated Interferon and Imatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT00297570
SHEBA-06-4015-IH-CTIL

Details and patient eligibility

About

The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy.

Exclusion criteria

  • Patients in imatinib study
  • Patients with a history of intolerability to interferon.
  • Patients with less than CCR or less than one year of imatinib therapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Izhar Hardan, MD

Data sourced from clinicaltrials.gov

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