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A Phase II Trial of IV Busulfan (Busulfex) and Melphalan as a Preparatory Regimen Prior to Allogeneic Bone Marrow Transplantation for the Treatment of Advanced and High Risk Hematologic Malignancies


Phase 2
N/A
N/A
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

A Phase II Trial of IV Busulfan (Busulfex) and Melphalan as a Preparatory Regimen Prior to Allogeneic Bone Marrow Transplantation for the Treatment of Advanced and High Risk Hematologic Malignancies


OBJECTIVES:

- Determine the antileukemic potential of busulfan and melphalan prior to allogeneic bone
marrow transplantation in patients with advanced or high-risk hematologic malignancy.

- Determine the incidence of transplantation-related morbidity and mortality in patients
treated with this regimen.

- Determine the incidence of acute and chronic graft-versus-host disease in patients
treated with this regimen.

OUTLINE: Patients receive cytoreductive chemotherapy comprising busulfan IV over 2 hours
every 6 hours for a total of 16 doses on days -8 to -5 and melphalan IV over 30 minutes on
days -4 to -2. Patients undergo T-cell replete allogeneic bone marrow transplantation on day
0. For graft-versus-host disease prophylaxis, patients receive tacrolimus IV continuously or
every 12 hours beginning on day -1 and continuing for 50 days to 6 months followed by a
taper. Once oral medications are tolerated, patients switch to oral tacrolimus every 12
hours. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Patients are followed weekly through day 100, every 6 weeks for 3 months, every 3 months for
1 year, and then every 3-6 months for 6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of one of the following:

- Infant leukemia

- Acute lymphoblastic leukemia in 3rd or greater remission or relapse

- Undifferentiated or biphenotypic leukemia in 2nd or greater remission or relapse

- Juvenile chronic myelogenous leukemia (CML)

- Acute myelogenous leukemia (AML) in 3rd or greater remission or relapse

- Primary advanced myelodysplastic syndrome (MDS) excluding refractory anemia (RA)
and RA with ringed sideroblasts

- Therapy-related MDS of any stage or AML

- CML in 2nd or greater chronic phase, accelerated, or blastic phase

- Acute leukemia, CML, or MDS but unable to tolerate total body irradiation (TBI)
due to potential neurotoxicity (prior TBI, prior local radiotherapy,or under 2
years of age)

- No active CNS disease

- Related or unrelated bone marrow donor matched at HLA-A, B, and DR beta 1

PATIENT CHARACTERISTICS:

Age:

- Under 60 (over 60 considered on case-by-case basis)

Performance status:

- Karnofsky 70-100%

- Lansky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- AST and ALT less than 2 times upper limit of normal

- Bilirubin less than 1.5 mg/dL unless liver is involved with disease

Renal:

- Creatinine normal

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- Asymptomatic with no prior risk factors OR

- LVEF greater than 50% if symptomatic

Pulmonary:

- Asymptomatic with no prior risk factors OR

- Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if
symptomatic

Other:

- No active uncontrolled viral, bacterial, or fungal infection

- Not pregnant or nursing

- Negative pregnancy test

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- More than 6 months since prior allogeneic or autologous stem cell transplantation

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Trudy N. Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-126

NCT ID:

NCT00014469

Start Date:

December 2000

Completion Date:

May 2007

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • acute undifferentiated leukemia
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • graft versus host disease
  • refractory cytopenia with multilineage dysplasia
  • juvenile myelomonocytic leukemia
  • childhood chronic myelogenous leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021