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Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
This study is ongoing, but not recruiting participants.
Study NCT00005622   Information provided by National Cancer Institute (NCI)
First Received: May 2, 2000   Last Updated: February 6, 2009   History of Changes

May 2, 2000
February 6, 2009
June 2000
 
  • Survival [ Designated as safety issue: No ]
  • Incidence and severity of acute and chronic graft versus host disease [ Designated as safety issue: No ]
  • Relapse rates [ Designated as safety issue: No ]
  • Incidence and severity of infectious complications [ Designated as safety issue: No ]
  • Survival
  • Incidence and severity of acute and chronic graft versus host disease
  • Relapse rates
  • Incidence and severity of infectious complications
Complete list of historical versions of study NCT00005622 on ClinicalTrials.gov Archive Site
 
 
 
Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.

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.

Phase II
Interventional
Treatment
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Drug: cyclophosphamide
  • Drug: leucovorin calcium
  • Drug: methotrexate
  • Procedure: allogeneic bone marrow transplantation
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
15 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005622
 
CDR0000067763, MCC-11282, MCC-IRB-4189, NCI-G00-1755
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study Chair: Teresa Field, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP