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

NCT ID: NCT00005622

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Myeloproliferative Disorders Leukemia Multiple Myeloma and Malignant Plasma Cell Neoplasms Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cy/TBI

cyclophosphamide and total body irradiation (TBI)

Group Type OTHER

cyclophosphamide

Intervention Type DRUG

Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)

TBI

Intervention Type RADIATION

FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.

Interventions

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cyclophosphamide

Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)

Intervention Type DRUG

TBI

FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresa Field, MD, PhD

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-4189

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G00-1755

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-11282

Identifier Type: -

Identifier Source: org_study_id