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Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors


Phase 2
15 Years
50 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors


OBJECTIVES:

- Determine the survival of allogeneic bone marrow transplantation using closely matched
related and unrelated donors in patients with malignant or nonmalignant hematological
disorders.

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

- Determine the relapse rates with this treatment regimen in those patients with
malignant disorders.

- Determine the incidence and severity of infectious complications associated with this
treatment regimen in these patients.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body
radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.

Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the
beginning of the study. If CNS involvement is documented, patients receive a second dose of
methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses.
Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week
for 12 weeks after transplant.

Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant.
Patients with ALL receive total body radiotherapy for 5 consecutive days prior to
transplant.

Patients are followed once a week for 3 months, and then monthly for 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of one of the following:

- Acute lymphocytic leukemia (ALL):

- Complete remission (CR) 1 - high risk defined as overt CNS involvement or
poor cytogenetics (additions, deletions, translocations, or multiple
abnormalities)

- CR2

- Induction failures

- Relapse - patients with at least 10% marrow blasts undergo at least one
reinduction attempt

- Acute myelogenous leukemia (AML):

- CR1 - high risk defined as poor cytogenetics (deletions, additions,
multiple abnormalities)

- CR2

- Induction failures

- Relapse - patients with at least 10% marrow blasts undergo at least one
reinduction attempt

- Chronic myelogenous leukemia (CML):

- Chronic phase (CP) 1

- Accelerated phase/CP2 - patients in blast phase must undergo treatment and
achieve a second chronic phase prior to transplant

- Chronic lymphocytic leukemia (CLL):

- Relapse - any stage; must have received no more than 3 prior regimens

- Multiple myeloma:

- At diagnosis - primary refractory

- Relapse (no more than 2) - sensitive disease

- Plasma cell leukemia

- Inability to achieve a complete remission after autologous transplant (no
older than 40)

- Myelodysplasia - all subtypes

- Myeloproliferative disorders - patients with poor response to medical therapy or
cytogenetic abnormalities

- Severe aplastic anemia (SAA):

- Very SAA - at diagnosis

- SAA - induction therapy

- Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch

PATIENT CHARACTERISTICS:

Age:

- 15 to 50

Performance status:

- Karnofsky 80-100%

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT and SGPT no greater than 3 times normal

- PT/PTT normal

Renal:

- Creatinine no greater than 2.0 mg/dL

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- Left ventricular ejection fraction at least 45%

- No myocardial infarction within past 6 months

- No uncontrolled arrhythmias

Pulmonary:

- FEV1 at least 50%

- DLCO at least 50% predicted

Other:

- No active serious infection

- HIV negative

- Not pregnant or nursing

- No uncontrolled diabetes mellitus or thyroid disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

event free survival (EFS)

Outcome Description:

EFS determined by the Kaplan-Meier product limit method

Outcome Time Frame:

five year post transplant

Safety Issue:

No

Principal Investigator

Teresa Field, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

MCC-11282

NCT ID:

NCT00005622

Start Date:

May 1996

Completion Date:

July 2009

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Multiple Myeloma and Malignant Plasma Cell Neoplasms
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • recurrent childhood acute lymphoblastic leukemia
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic 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
  • polycythemia vera
  • primary myelofibrosis
  • essential thrombocythemia
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • refractory cytopenia with multilineage dysplasia
  • chronic eosinophilic leukemia
  • chronic neutrophilic 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)
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location
Moffitt Cancer Center Tampa, Florida  33612