Stem Cell Transplantation in Treating Patients With Hematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004904
First received: March 7, 2000
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Small Intestine Cancer
Biological: anti-thymocyte globulin
Biological: filgrastim
Drug: cladribine
Drug: cyclophosphamide
Drug: etoposide
Drug: methylprednisolone
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of T Cell Depleted (TCD) Partially Matched Related Donor (PMRD) Hematopoietic Stem Cell Transplantation for High Risk Hematologic Diseases Using Intense Pre and Post Transplant Immunosuppression and Megadose CD34 "Veto" Cells

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphoma, Small Cleaved-cell, Diffuse Lymphosarcoma B-cell Lymphomas Follicular Lymphoma Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Acute Myeloid Leukemia, Adult Multiple Myeloma Acute Lymphoblastic Leukemia Cutaneous T-cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Waldenstrom Macroglobulinemia Mantle Cell Lymphoma Burkitt Lymphoma Lymphoma, Large-cell Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Hairy Cell Leukemia Homologous Wasting Disease Chronic Myeloproliferative Disorders Large Granular Lymphocyte Leukemia Mycosis Fungoides Sezary Syndrome Acute Myeloid Leukemia, Childhood Leukemia, T-cell, Chronic Small Non-cleaved Cell Lymphoma Monoclonal Gammopathy of Undetermined Significance Small Intestine Cancer Myelofibrosis Polycythemia Vera Essential Thrombocythemia AL Amyloidosis Anaplastic Plasmacytoma
U.S. FDA Resources

Further study details as provided by Northwestern University:

Study Start Date: October 1999
Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine if megadose CD34 cells and intense immunosuppression administered before and after partially matched related donor (PMRD) hematopoietic stem cell (HSC) transplantation results in engraftment in patients with high risk hematologic malignancies. II. Determine the incidence and severity of acute grade (I-IV) and chronic (limited or extensive) graft versus host disease in patients after rigorous T-cell depletion in PMRD HSC transplantation.

OUTLINE: Harvest: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a related 1, 2, or 3 HLA antigen mismatched donor. PBSC are selected for CD34+ cells and T-cells are depleted. Conditioning: Patients undergo total body irradiation twice daily on days -10 to -7 and once on day -6. Patients receive cladribine IV continuously on days -10 to -6; etoposide IV over 2 hours on day -5; and cyclophosphamide IV over 2 hours, antithymocyte globulin (ATG) IV over 10-12 hours, and methylprednisolone IV over 1 hour on days -4 to -2. Transplantation: T-cell depleted PBSC and bone marrow are infused on day 0. Patients receive G-CSF SQ daily beginning on day 0 and continuing until blood counts recover. Graft versus host disease prophylaxis: Patients receive tacrolimus IV every 12 hours beginning on day -2 and continuing orally 4 times a day for 6-12 months at the discretion of the protocol investigator. Patients receive ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days 5-15 followed by a taper of methylprednisolone. Patients are followed every week through day 100 and then at 6 and 12 months.

PROJECTED ACCRUAL: A total of 12-20 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy with relapse after allogeneic bone marrow transplantation (BMT) or autologous BMT if no HLA matched sibling donor is available OR Histologically proven acute myeloid leukemia (AML) without an available HLA matched sibling donor and with one of the following: Failure of induction, defined as inability to obtain remission with 2 courses of induction or failure during treatment Second or greater remission OR Histologically proven acute lymphocytic leukemia (ALL) in an adult over age 15 without an available HLA matched sibling donor and with one of the following: Philadelphia chromosome positivity by cytogenetics or PCR Relapse or second or greater remission Two or more prognostic features (over age 30, WBC on presentation over 35,000/mm3, time to complete response over 4 weeks, t(4:11), or B-cell ALL) OR Histologically proven chronic myelogenous leukemia In chronic phase without an A, B, and DR unrelated matched donor OR In accelerated phase, defined as new cytogenetic abnormalities or difficulty maintaining a normal WBC due to dose limiting cytopenias (thrombocytopenias or anemia) from hydroxyurea or interferon OR In blast transformation OR Histologically proven aplastic anemia without an available HLA matched sibling donor and failure of an immunosuppressive therapy regimen using either cyclosporine, antithymocyte globulin, or both OR Histologically proven lymphoma without an available HLA matched donor and failure of at least 2 different chemotherapy regimens OR Histologically proven cutaneous T-cell lymphoma without an available HLA matched donor and failure of interferon and PUVA (psoralen and ultraviolet A radiation) OR Histologically proven myelodysplastic syndrome without an available HLA matched sibling donor and with one of the following: 5% or greater blasts in marrow Multiple cytogenetic abnormalities History of infections from neutropenia 1, 2, or 3 antigen mismatched related donor available

PATIENT CHARACTERISTICS: Age: Physiologic age 45 and under Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No coronary artery disease requiring medical therapy Resting LVEF at least 40% Pulmonary: FEV1/FVC at least 60% predicted DLCO at least 60% predicted Other: HIV negative No prior malignancy except basal cell or squamous cell skin cancer Other malignancies for which the patient is cured by local surgical therapy, such as head and neck cancer or stage I breast cancer, are considered on an individual basis Not pregnant Negative pregnancy test Fertile patients must use effective contraception No psychiatric illness or mental deficiency that would preclude compliance or informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004904

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Richard K. Burt, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004904     History of Changes
Other Study ID Numbers: NU FDA97H1, NU-97H1, NCI-G00-1691
Study First Received: March 7, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
monoclonal gammopathy of undetermined significance
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
small intestine lymphoma
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
polycythemia vera
chronic idiopathic myelofibrosis
essential thrombocythemia
refractory hairy cell leukemia
T-cell large granular lymphocyte leukemia
acute undifferentiated leukemia
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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Graft vs Host Disease
Lymphoma
Leukemia
Syndrome
Myeloproliferative Disorders
Plasmacytoma
Precancerous Conditions
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Lymphatic Diseases
Disease
Pathologic Processes
Cyclophosphamide
Antilymphocyte Serum
Methylprednisolone Hemisuccinate

ClinicalTrials.gov processed this record on October 01, 2014