Bone Marrow Transplantation in Treating Patients With Hem... | NCT00003398 | Trialant
NCT00003398
Sponsor
University of Maryland, Baltimore
Status
Completed
Last Update Posted
Oct 17, 2019Actual
Enrollment
45Estimated
Phase
Phase 4
Conditions
Anemia
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions
anti-thymocyte globulin
filgrastim
cyclophosphamide
thiotepa
allogeneic bone marrow transplantation
bone marrow ablation with stem cell support
radiation therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00003398
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000066400
Secondary IDs
ID
Type
Description
Link
MSGCC-9739
NCI-V98-1433
Brief Title
Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Official Title
Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor
Acronym
Not provided
Organization
University of Maryland, BaltimoreOTHER
Status Module
Record Verification Date
Oct 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 1998
Primary Completion Date
May 2000Actual
Completion Date
May 2000Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Apr 26, 2004
First Posted Date
Apr 27, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 15, 2019
Last Update Posted Date
Oct 17, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
University of Maryland, BaltimoreOTHER
Collaborators
Name
Class
University of Maryland Greenebaum Cancer Center
OTHER
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor.
Detailed Description
OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients undergoing transplantation with an unrelated or related matched or mismatched antigen donor. II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this patient population.
OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8 to -5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic bone marrow transplantation on day 0. Bone marrow is harvested from patient's donor, depleted of T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4.
PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4 years.
Conditions Module
Conditions
Anemia
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Keywords
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
Burkitt lymphoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
45Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
anti-thymocyte globulin
Biological
filgrastim
Biological
cyclophosphamide
Drug
thiotepa
Drug
allogeneic bone marrow transplantation
Procedure
bone marrow ablation with stem cell support
Procedure
radiation therapy
Radiation
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven malignancy or condition of the following types: Acute myelogenous leukemia (not M5 or M6) or lymphocytic leukemia in first or greater remission or early relapse OR Chronic myelogenous leukemia OR Myelodysplastic syndrome OR Aggressive or refractory non-Hodgkin's lymphoma OR Aggressive or refractory Hodgkin's disease OR Multiple myeloma at early relapse or after conventional chemotherapy to reduce tumor mass OR High risk chronic lymphocytic leukemia OR Aplastic anemia HLA-matched or 1 antigen mismatched (related or unrelated) available as donor
PATIENT CHARACTERISTICS: Age: 50 and under Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL SGOT less than 4 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50% by MUGA Pulmonary: DLCO at least 50% Other: HIV negative No active extramedullary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
50 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Barry R. Meisenberg, MD
University of Maryland Greenebaum Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore
Maryland
21201
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal 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
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute promyelocytic leukemia (M3)
adult acute myelomonocytic leukemia (M4)
adult acute eosinophilic leukemia
adult acute basophilic leukemia
adult acute megakaryoblastic leukemia (M7)
childhood acute myeloblastic leukemia with maturation (M2)
childhood acute promyelocytic leukemia (M3)
childhood acute myelomonocytic leukemia (M4)
childhood acute eosinophilic leukemia
childhood acute basophilic leukemia
childhood acute megakaryocytic leukemia (M7)
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent adult diffuse small cleaved cell lymphoma