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Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00005622
First received: May 2, 2000
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Multiple Myeloma and Malignant Plasma Cell Neoplasms
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Drug: cyclophosphamide
Radiation: TBI
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • event free survival (EFS) [ Time Frame: five year post transplant ] [ Designated as safety issue: No ]
    EFS determined by the Kaplan-Meier product limit method


Secondary Outcome Measures:
  • Incidence of graft versus host disease [ Time Frame: five years post transplant ] [ Designated as safety issue: No ]
    incidence and severity of acute and chronic GVHD


Enrollment: 72
Study Start Date: May 1996
Study Completion Date: July 2009
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cy/TBI
cyclophosphamide and total body irradiation (TBI)
Drug: cyclophosphamide
Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)
Radiation: TBI
FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005622

Locations
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Teresa Field, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00005622     History of Changes
Other Study ID Numbers: MCC-11282, IRB-4189, NCI-G00-1755
Study First Received: May 2, 2000
Last Updated: October 24, 2012
Health Authority: United States: Federal Government

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
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

Additional relevant MeSH terms:
Disease
Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms, Plasma Cell
Plasmacytoma
Preleukemia
Syndrome
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Paraproteinemias
Pathologic Processes
Precancerous Conditions
Vascular Diseases
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 20, 2014