Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.

Conditions

• Leukemia

Interventions

BIOLOGICAL

Filgrastim

Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.

DRUG

Busulfan

Administered orally every 6 hours on consecutive days -6 through -4.

DRUG

Cyclophosphamide

Given intravenously (IV) over 1 hour on consecutive days -3 and -2.

DRUG

Cyclosporine

Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.

DRUG

Decitabine (DAC)

IV over 4 hours on days -8 and -7.

DRUG

Methotrexate

Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.

DRUG

Methylprednisolone

Given according to clinical grade of GVHD procedures.

DRUG

Tacrolimus

IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.

PROCEDURE

Allogeneic Bone Marrow Transplantation

Infusion of stem cells on Day 0.

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Stem cell infusion on Day 0.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Sergio Giralt, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-08-01

Primary Completion

2002-12-31

Completion

2002-12-31

Countries

• United States

Study Locations