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A Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Chronic Myeloid Leukemia (CML) and Adoptive Cellular Immunotherapy Only in Patients With Persistent Disease and Matched Family Donors


Phase 2
N/A
30 Years
Not Enrolling
Both
Chronic Myeloid Leukemia

Thank you

Trial Information

A Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Chronic Myeloid Leukemia (CML) and Adoptive Cellular Immunotherapy Only in Patients With Persistent Disease and Matched Family Donors


Further study details will be provided by Columbia University, Division of Pediatric Blood
and Marrow Transplantation.

STUDY DESIGN:

Patients less than 30 years of age with CML in 1st or 2nd chronic phase or 1st accelerated
phase and a matched related donor, an unrelated cord blood donor, or an unrelated adult
donor, will receive 6 days of IV Fludarabine, 4 doses of IV Busulfex, and 5 doses of
Alemtuzumab. Patients with persistant RT-PCR positive BCR-Abl and/or Philadelphia chromosome
positivity by cytogentics after Day + 100 and a matched related donor would receive DLIx1.
If still BCR-Abl or Philadelphia chromosome positive at Day +180 and a matched related
donor, patients would receive a second dose of DLI. All patients will receive STI-571
(Gleevec) after hematological reconstitution. Studies for immune reconstitution, chimersim,
and MRD will be performed postt AlloSCT.


Inclusion Criteria:



- Age: Patient must be less than 30 years of age.

- Consent: Patient or the patient's legally authorized guardian must be fully informed
about their illness and the investigational nature of the study protocol (including
foreseeable risks and possible side effects), and must sign an informed consent in
accordance with the institutional policies approved by the U.S. Department of Health
and Human Services.

- Organ Function: Patient must have adequate organ function as below Adequate renal
function defined as:Serum creatinine 1.5 x normal, or Creatinine clearance or
radioisotope GFR > 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as
determined by the institutional normal range

- Adequate liver function defined as:Total bilirubin < 2.5 x normal; or SGOT (AST) or
SGPT (ALT) < 5.0 x normal

- Adequate cardiac function defined as:

- Shortening fraction of >25% by echocardiogram, or

- Ejection fraction of >40% by radionuclide angiogram or echocardiogram

- Adequate pulmonary function defined as:

-DLCO >40% by pulmonary function test For children who are uncooperative, no evidence
of dyspnea at rest,no exercise intolerance, and a pulse oximetry >94% in room air.

- Disease Status

- Patients with CML with either of the following:

- Patients in 1st or 2nd chronic phase

- Patients in 1st or 2nd accelerated phase

Exclusion Criteria:

- Patient in blast crisis

- Patient in 3rd or greater chronic phase

- Patient in 3rd or greater accelerated phase

- women that are pregnant are ineligible

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the toxicity associated with reduced intensity therapy and allogeneic SCT in selected patients with CML.

Outcome Time Frame:

Until Study End

Safety Issue:

Yes

Principal Investigator

Mtchell S Cairo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAA8191

NCT ID:

NCT00531310

Start Date:

January 2003

Completion Date:

June 2010

Related Keywords:

  • Chronic Myeloid Leukemia
  • CML
  • allogeneic SCT
  • matched family donor
  • unrelated donor
  • cord blood donor
  • persistent disease
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Morgan Stanley Children's Hospital of NYP New York, New York  10032