ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Massey Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003187
  Purpose

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of conventional bone marrow transplantation with T cell-depleted bone marrow transplantation in treating patients who have leukemia, myelodysplasia, or lymphoblastic lymphoma.


Condition Intervention Phase
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: filgrastim
Drug: methotrexate
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
Procedure: radiation therapy
Phase II
Phase III

MedlinePlus related topics:   Anemia    Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

Drug Information available for:   Cyclophosphamide    Filgrastim    Cytarabine    Cytarabine hydrochloride    Methotrexate    Methylprednisolone    Cyclosporine    Cyclosporin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   The Unrelated Donor Marrow Transplantation Trial

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   560
Study Start Date:   May 1995

Detailed Description:

OBJECTIVES: I. Compare the disease free survival of patients with leukemia, myelodysplasia, or lymphoblastic lymphoma after treatment with conventional (non-T cell depleted) or T cell depleted unrelated donor bone marrow transplantation. II. Compare the incidence of primary and secondary graft failure, acute and chronic graft-vs-host disease, complications (infection, veno-occlusive disease, interstitial pneumonitis), and relapse in these patients after these treatments. III. Compare the incidence of other malignancies, lymphoproliferative disorders, and post-transplant myelodysplasia in these patients after these treatments.

OUTLINE: This is a randomized, multicenter study. Patients will be stratified according to institution. Patients are assigned to one of two treatment arms, one with conventional bone marrow transplantation (arm I) and one with T cell depletion of the bone marrow (arm II). Arm I: Patients receive cyclophosphamide on days -6 and -5. Total body irradiation (TBI) is administered on days -4 to 0, although this order may be reversed. Males with ALL receive a testicular boost of radiation therapy. Bone marrow is infused on day 0. Patients receive cyclosporine beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Arm II: T cell depletion is conducted by 2 different methods, according to the institution, and treatment varies depending on the method used. Method I is by T10B9 depletion and Method II is by counterflow elutriation depletion. Method I: Depending on the institution, some patients receive TBI on days -9 to -7 (before chemotherapy) (Course I) and some receive TBI on days -3 to -1 (after chemotherapy) (Course II). Course I also includes cytarabine IV on days -5 to -3, cyclophosphamide IV on days -2 and -1, and methylprednisolone IV on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day -1. Course II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5. Methylprednisolone IV is administered on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day 0. Method II: Preparative therapy varies according to the disease category. Acute lymphoblastic leukemia: Patients undergo TBI on days -7 to -4. Males receive testicular boost on day -7, and all receive electron boost to anterior and posterior chest wall on days -5 and -4. Cyclophosphamide IV is administered on days -3 and -2. Bone marrow infusion is administered on day 0. Acute nonlymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome: Patients receive cyclophosphamide IV on days -7 and -6, followed by TBI on days -4 to -1. Bone marrow infusion is administered on day 0. Patients receive methylprednisolone IV every 12 hr on days -2,-1, and 5-19. Cyclosporine is administered from day -3 to day 180. All patients on both arms receive filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning on day 7 post-transplant. Patients are followed weekly for the first 14 weeks, at day 100, every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 4 years.

  Eligibility
Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Pathologically confirmed acute myeloid leukemia Not in first complete remission with translocations t(8;21) unless failed first line induction therapy Not in first complete remission with translocations t(15;17) or 16q abnormality unless: Failed first line induction therapy OR Molecular evidence of disease Pathologically confirmed acute lymphoblastic lymphoma (ALL) Not in first complete remission OR High risk ALL in first complete remission defined as: Hypodiploidy OR Pseudodiploidy with translocations t(9,22), t(4;11), or t(8;14) OR Elevated WBC at presentation Greater than 100,000/mm3 if 6-12 months old Greater than 50,000/mm3 if 10-20 years old Greater than 20,000/mm3 if 21 or over OR Failed to achieve complete remission after 4 weeks of induction therapy Pathologically confirmed chronic myelogenous leukemia (CML) not in blast crisis Pathologically confirmed undifferentiated leukemia or biphenotypic leukemia Pathologically confirmed juvenile CML with or without either 7q- or infantile monosomy 7 Leukocytosis with absolute monocytosis greater than 450 microliters AND Immature myeloid cells in peripheral blood circulation Less than 25% marrow blasts Myelodysplastic syndromes: Refractory anemia (RA) RA with ringed sideroblasts RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Pathologically confirmed stage IV lymphoblastic lymphoma No active CNS or skin leukemic involvement No consenting suitably HLA-matched related donor available Consenting unrelated donor available

PATIENT CHARACTERISTICS: Age: 55 and under Performance status: Karnofsky 70-100% OR Lansky 60-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL SGOT less than 3 times upper limit of normal Renal: Creatinine within normal range OR Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic OR Left ventricular ejection fraction at rest greater than 40% and improves with exercise Pulmonary: Asymptomatic OR DLCO greater than 45% Other: Not pregnant or lactating HIV negative No uncontrolled viral, bacterial, or fungal infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior autologous or allogeneic bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No concurrent mediastinal radiation No prior radiation therapy that would preclude total body irradiation Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003187

Locations
United States, California
Stanford University Medical Center    
      Stanford, California, United States, 94305-5408
United States, Iowa
University of Iowa Hospitals and Clinics    
      Iowa City, Iowa, United States, 52242
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky    
      Lexington, Kentucky, United States, 40536-0084
United States, Minnesota
University of Minnesota Medical School    
      Minneapolis, Minnesota, United States, 55455
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center    
      Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University    
      Columbus, Ohio, United States, 43210
United States, Pennsylvania
Western Pennsylvania Hospital    
      Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
University of South Carolina School of Medicine    
      Columbia, South Carolina, United States, 29203
United States, Utah
Huntsman Cancer Institute    
      Salt Lake City, Utah, United States, 84132
United States, Virginia
Massey Cancer Center    
      Richmond, Virginia, United States, 23298-0037
United States, Wisconsin
Midwest Children's Cancer Center    
      Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators
Massey Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Lee Ann Jensen, PhD     National Heart, Lung, and Blood Institute (NHLBI)    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066016, MCV-CCHR-9504-2X, DUMC-75951, NCI-G98-1388
First Received:   May 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003187
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
stage IV childhood lymphoblastic lymphoma  
recurrent childhood acute myeloid leukemia  
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
untreated adult acute lymphoblastic leukemia  
untreated adult acute myeloid leukemia  
untreated childhood acute myeloid leukemia and other myeloid malignancies  
untreated childhood acute lymphoblastic 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
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
acute undifferentiated leukemia
stage IV adult lymphoblastic lymphoma
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Study placed in the following topic categories:
Leukemia, Lymphoid
Cyclosporine
Precancerous Conditions
Chronic myelogenous leukemia
Clotrimazole
Methylprednisolone
Chronic myelomonocytic leukemia
Refractory anemia
Miconazole
Prednisolone acetate
Cyclophosphamide
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Acute
Cyclosporins
Acute lymphoblastic leukemia, adult
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Methotrexate
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Lymphoma
Cytarabine
Methylprednisolone Hemisuccinate
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Neuroprotective Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Antifungal Agents
Abortifacient Agents
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers