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Bone Marrow Transplant in Treating Patients With Hematologic Cancers

NCT00005797 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2020-12-10

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

busulfan

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

DRUG

Cyclophosphamide

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

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.

RADIATION

Fractionated Total Body Irradiation (FTBI)

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Teresa Field, MD, PhD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-03-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005797 on ClinicalTrials.gov