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Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Primary Purpose

Leukemia, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan
cyclophosphamide
methylprednisolone
allogeneic bone marrow transplantation
in vitro-treated bone marrow transplantation
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory multiple myeloma, chronic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, acute undifferentiated leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched, sibling donor for BMT available No current CNS disease No history of more than 2 episodes of active CNS disease PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients must use effective contraception No concurrent debilitating medical or psychiatric illness that would preclude compliance No prior malignancy except curatively treated skin cancer or carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Sites / Locations

  • Johns Hopkins Oncology Center
  • Center for Cancer Treatment and Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 1, 2014
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003960
Brief Title
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Official Title
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
September 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.
Detailed Description
OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose chemotherapy. OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and then tapered. Patients are followed every 6 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Keywords
refractory multiple myeloma, chronic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, acute undifferentiated leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
in vitro-treated bone marrow transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched, sibling donor for BMT available No current CNS disease No history of more than 2 episodes of active CNS disease PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients must use effective contraception No concurrent debilitating medical or psychiatric illness that would preclude compliance No prior malignancy except curatively treated skin cancer or carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul V. O'Donnell, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Center for Cancer Treatment and Research
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States

12. IPD Sharing Statement

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Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

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