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Bone Marrow Transplant in Treating Patients With Hematologic Cancers

NCT ID: NCT00005797

Last Updated: 2020-12-10

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-03-31

Study Completion Date

2007-07-31

Brief Summary

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RATIONALE: Giving chemotherapy drugs 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 healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow 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 hematologic cancers.

Detailed Description

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OBJECTIVES:

* Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation (BMT).
* Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body irradiation, and allogeneic BMT.
* Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients.
* Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia.

OUTLINE:

* Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT). Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic bone marrow is infused on day 0.
* Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI. Allogeneic bone marrow is infused on day 0.

Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis.

Patients are followed weekly for 3 months and then monthly for 1 year.

PROJECTED ACCRUAL: At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients with high risk myeloid disease will be accrued for this study.

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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refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic 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 adult acute myeloid leukemia in remission adult 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 previously treated 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BuCy2

Busulfan \& Cyclophosphamide

Group Type OTHER

busulfan

Intervention Type DRUG

administered on Day -7 through Day -4. The total dose is 12.8 mg/kg

Cyclophosphamide

Intervention Type DRUG

administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)

VP16/TBI

Fractionated Total Body Irradiation + VP-16

Group Type OTHER

VP-16

Intervention Type DRUG

administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is \>/= 150% of IBW, in which case adjusted body weight will be used.

Fractionated Total Body Irradiation (FTBI)

Intervention Type RADIATION

FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.

Interventions

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busulfan

administered on Day -7 through Day -4. The total dose is 12.8 mg/kg

Intervention Type DRUG

Cyclophosphamide

administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)

Intervention Type DRUG

VP-16

administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is \>/= 150% of IBW, in which case adjusted body weight will be used.

Intervention Type DRUG

Fractionated Total Body Irradiation (FTBI)

FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.

Intervention Type RADIATION

Other Intervention Names

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Busulfex® Etoposide (VP-16; Vepesid(R) brand only)

Eligibility Criteria

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Inclusion Criteria

* Myeloproliferative disorders

* Poor response to medical therapy OR
* Cytogenetic abnormalities
* Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match

* Molecular DR matching required

PATIENT CHARACTERISTICS:

Age:

* 15 to 55

Performance status:

* Karnofsky 80-100%

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 3 times upper limit of normal
* PT/PTT normal

Renal:

* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* LVEF at least 45% by MUGA scan or echocardiography
* No myocardial infarction within the past 6 months
* No arrhythmias controlled by therapy

Pulmonary:

* FEV\_1 at least 50% predicted
* DLCO at least 50% predicted

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No diabetes mellitus or thyroid disease that is not medically controlled
* No psychosocial disorder that would preclude study compliance
* No active serious infections
* HIV negative
* Donor must be HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 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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H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-IRB-4188

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G00-1759

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MCC-11281

Identifier Type: -

Identifier Source: org_study_id