Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003960
First received: November 1, 1999
Last updated: May 1, 2014
Last verified: May 2014

November 1, 1999
May 1, 2014
April 1998
September 2001   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003960 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Drug: methylprednisolone
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: in vitro-treated bone marrow transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2001
September 2001   (final data collection date for primary outcome measure)

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

Both
19 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003960
J9828 CDR0000067159, P30CA006973, JHOC-98032006, JHOC-J9828, NCI-G99-1543
Not Provided
Not Provided
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Paul V. O'Donnell, MD, PhD Fred Hutchinson Cancer Research Center
Sidney Kimmel Comprehensive Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP