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Phase II Trial of Clofarabine With Parenteral Busulfan (Busulfex®) Followed by Allogeneic Related or Unrelated Donor Transplantation for the Treatment of Hematologic Malignancies and Diseases


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase II Trial of Clofarabine With Parenteral Busulfan (Busulfex®) Followed by Allogeneic Related or Unrelated Donor Transplantation for the Treatment of Hematologic Malignancies and Diseases


The success of allogeneic hematopoietic transplantation in the treatment of myeloid
malignancies is determined by two main factors: the limiting of regimen-related toxicity and
the prevention of recurrent leukemia. Over the past 10 years, considerable clinical
research has been devoted to the reduction of regimen-related toxicity through the use of
reduced-intensity (nonmyeloablative) transplants. However, leukemic relapse has remained a
difficult obstacle. Thus, the need for highly effective, yet non-toxic regimens persists,
particularly for elderly patients for whom very little overall progress has been made.
Clofarabine is a chemotherapeutic agent with novel myelotoxic properties and proven low
toxicity in older patients. These qualities suggest clofarabine may be a useful component
of conditioning regimens for stem cell transplantation.


Inclusion Criteria:



Disease Criteria:

- Acute myelogenous leukemia (AML)

- Acute lymphocytic leukemia (ALL)

- Myelodysplastic syndromes (MDS) Refractory anemia (RA) with adverse cytogenetics
(SWOG criteria) or beyond (RAEB, RAEB-T, AML)

- Other Myeloproliferative Disorders Myelofibrosis, Agnogenic Myeloid Metaplasia,
Chronic Myelomonocytic Leukemia (CMML)

- Chronic lymphocytic leukemia (CLL) High risk or advanced disease

Other

Inclusion Criteria:



- 18 years of age or older

- Related or unrelated donor with HLA criteria as follows:

- Related donors: a serologic equivalent HLA Class I (A, B, and C) and Class II
DRB1 or DQB1 matched donor OR a donor who is a single 1 antigen mismatched for
A, B, C, DRB1, or DQB1 loci

- Unrelated donors: sequence-based typing fully matched A, B, C, DRB1, and DQB1
allele-matched donor OR a donor who is no greater than 1 antigen mismatched for
A, B, C, DRB1, or DQB1 loci

- Able to provide valid informed consent.

- Female patients must have a negative serum pregnancy test within 2 weeks prior to
enrollment.

- Male and female patients must use an effective contraceptive method during the study
and for up to 12 months after study treatment.

Exclusion Criteria:

Organ Function Criteria:

- Cardiac: symptomatic coronary artery disease or ejection fraction <45% or
uncontrolled cardiac failure

- Pulmonary: FEV1 or DLCO (corrected) <50% of predicted values and/or receiving
continuous supplementary oxygen

- Hepatic: Bilirubin ≥ 1.2 mg/dL or AST/ALT ≥ 3x upper limit of normal (ULN) unless the
liver is involved with malignant disease

- Renal: creatinine clearance < 60 mL/min (24-hour urine collection) or <50 mL/min
(Glofil test)

- Karnofsky score <60%

- Active CNS disease

- Prior hematopoietic transplantation (autologous or allogeneic) <6 months prior to
study entry

- Use of investigational agents less than or equal to 30 days before study entry.

- Life threatening, or clinically significant infection

- Any significant concurrent disease, illness, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results.

- Female patients who are pregnant or breast feeding

- HIV-positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease free survival at one and two year

Outcome Time Frame:

At 1 year and 2 Year

Safety Issue:

No

Principal Investigator

Edward Agura, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Health Care System

Authority:

United States: Institutional Review Board

Study ID:

006-150

NCT ID:

NCT00852163

Start Date:

March 2007

Completion Date:

December 2011

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndrome
  • conditioning, preparative
  • clofarabine; transplant
  • Busulfan
  • leukemia
  • myelodysplastic syndrome
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Baylor University Medical CenterDallas, Texas  75246