Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL

NCT00041288 | Terminated Phase 2 DMC

• 7 other identifiers: CDR0000069462UTSMC-0501228AMGEN-UTSMC-0501228IBMTR-SC-00-02.1ROCHE-UTSMC-0501228SPRI-UTSMC-0501228NCI-V02-1706
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 23

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Conditions

Leukemia; Lymphoma

Keywords

Waldenstrom macroglobulinemia; refractory chronic lymphocytic leukemia; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent small lymphocytic lymphoma

Interventions

therapeutic allogeneic lymphocytes BIOLOGICAL

cyclophosphamide DRUG

cyclosporine DRUG

fludarabine phosphate DRUG

methotrexate DRUG

mycophenolate mofetil DRUG

tacrolimus DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of chronic lymphocytic leukemia or * Diagnosis of non-Hodgkin's lymphoma * Lymphoplasmacytic lymphoma * Grade I follicular small cleaved cell lymphoma * Grade II follicular mixed cell lymphoma * Diffuse small cleaved cell lymphoma * Small lymphocytic lymphoma * Relapsed after at least 1 course of prior therapy * Availability of a 6/6 human leukocyte antigen (HLA) A, B, and DR identical sibling donor * Nonmyeloablative transplantation candidate * No clinically significant effusions or ascites that would preclude administration of methotrexate PATIENT CHARACTERISTICS: -Age: 18 to 75 Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 OR Zubrod 0-2 * Life expectancy: At least 6 months * Hematopoietic: Not specified * Hepatic: Bilirubin no greater than 3 mg/dL * Renal: Creatinine no greater than 2 mg/dL * Cardiovascular: left ventricular ejection fraction (LVEF) at least 40% on multigated acquisition (MUGA) scan or echocardiogram * Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) at least 50% of predicted OTHER: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled bacterial, viral, fungal, or parasitic infection * Human Immunodeficiency Virus (HIV)1 and Human Immunodeficiency Virus (HIV)2 negative * No other active malignancy except basal cell skin cancer * No recent history of drug or alcohol abuse * No other primary disease or comorbid illness that would severely limit life expectancy PRIOR CONCURRENT THERAPY * Biologic therapy:See Disease Characteristics * Biologic therapy:Prior autologous bone marrow transplantation allowed if disease has progressed after transplantation * Biologic therapy:No entry on study as part of a tandem autologous transplantation followed by nonmyeloablative allograft protocol * Chemotherapy: Not specified * Endocrine therapy: Not specified * Radiotherapy:Not specified * Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (23)

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Delaware Clinical & Laboratory Physicians

Newark, Delaware, 19713, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342-1601, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

University of Missouri Kansas City School of Medicine

Kansas City, Missouri, 64111, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Oregon Cancer Institute

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37212, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-8590, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M4S 1KN, Canada

Location

University of Toronto

Toronto, Ontario, M5S 1A8, Canada

Location

Hopital du Saint-Sacrament, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Waldenstrom Macroglobulinemia; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, Non-Hodgkin

Interventions

Cyclophosphamide; Cyclosporine; fludarabine phosphate; Methotrexate; Mycophenolic Acid; Tacrolimus; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Macrolides; Lactones; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Robert H. Collins, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

US (19); CA (4)