Clinical trial NCT00244829: Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
Official title: A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Keywords: accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2005-10-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia.

PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

Detailed description: OBJECTIVES:

Primary

* Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.

Secondary

* Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
* Determine the 1-year survival of patients treated with this drug.

OUTLINE: This is an open-label, pilot, multicenter study.

Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p\^190 and/or p\^210 bcr/abl gene rearrangement
  * Accelerated or blastic phase CML
  * CML in second or greater chronic phase
* No imatinib mesylate-resistant leukemia
* Planned allogeneic hematopoietic stem cell transplantation

  * Availability of an appropriately matched related or unrelated donor
  * Autologous or nonmyeloablative transplantation is not allowed
* None of the following within 4 days after the date of neutrophil engraftment\*:

  * More than 5% marrow blasts
  * Circulating peripheral blood leukemic blasts
  * Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay
  * Presence of bcr/abl in \> 5% of marrow interphase nuclei by fluorescent in situ hybridization
  * More than 1 of 20 Philadelphia chromosome-positive marrow metaphases
  * CNS involvement by leukemia NOTE: \*The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* At least 2 months

Hematopoietic

* See Disease Characteristics
* Absolute neutrophil count ≥ 1,200/mm\^3 (use of filgrastim \[G-CSF\] allowed)

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known imatinib mesylate hypersensitivity
* No other disease that severely limits life expectancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Primary outcomes:
measure: Safety at 90 days following transplant
Secondary outcomes:
measure: BCR/ABL transcript load at 90 days following transplant
measure: Standard management of progressive minimal residual disease at 90 days following transplant
measure: Survival at 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Paul Carpenter, MD
role: STUDY_CHAIR
References: